Careers at Knipper

At Knipper, our most valuable resource is our people. With experienced leadership from across the life science industries and a diverse workforce possessing a myriad of skill sets and expertise, our employees are what differentiate us most from our competition. It takes special people to so firmly adopt and continuously demonstrate the type of customer-centric culture that is the hallmark of all Knipper solutions. Committed – driven – intelligent people that can listen effectively, ask the right questions, build the right teams, and develop the best tools and processes to deliver success every time.

We are committed to our employee’s success. We believe in building a solid working relationship with each of our employees that is founded in mutual trust and caring. We want every Knipper employee to be successful in their career, to learn and grow, and to be well compensated for their efforts.

Sample Accountability Analyst (Somerset, NJ)

Job Description:

As a Sample Accountability Analyst you will be responsibile for working directly with internal staff and pharmaceutical sales representatives to perform drug sample inventory reconciliations. Some responsibilities will include: Analyzing reports and sample transactions, finding and correcting inventory transaction problems through research and analysis, working closely with internal teams to execute the clients PDMA program, work directly with sales representatives and sales operations personnel via phone and email for problem resolution, generating sample reconciliation reports, performing follow up activities with sales representatives who are not in compliance with their sample program, ensuring sample transaction paperwork is accurate and processed with agreed upon service levels, providing guidance to pharmaceutical sales representatives on how to comply with their program rules, enforcing program business rules and processes, seeking operational improvements.

Openings: 2


Requirements:

Business experience (2 or more years) working within the Sample Accountability/Compliance field, or in a financial field. A self starter who can work independently or on a team to execute detailed programs. Client focused with the ability to communicate effectively inside and outside of the organization. Working knowledge of PDMA preferred. Proficient in Microsoft Office with strong Excel skills.

Education:

Associate's Degree preferably in a business discipline.

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Business Systems Analyst - (Somerset, NJ)

Job Description:

The Business Systems Analyst’s role is to define and plan enabling solutions for drug sampling and literature fulfillment programs after gathering and analyzing business and systems requirements. In partnership with the head of System Design & Planning, BSA decides which solution best matches the business/technical needs, and determines whether the request represents configuration or modifications. The BSA works directly with customer-facing colleagues and pharmaceutical clients using effective communication and business acumen in tandem with a working technical knowledge of the company’s solution offerings. SDLC responsibilities include solution planning; requirements definition and documentation; facilitating development and testing; and preparing for the launch and operational support of the solution. Serve as the primary contact for the assigned information systems by being a liaison between technical staff and clients. Will be the IT product owner (subject matter expert) for the assigned information systems. Provide post-implementation support to all stakeholders including triaging system problems. Identify the best solution to a job request and coordinate the resolution accordingly. Accountable for system administration including, client and user setup, and business rule configurations for the assigned information systems. Plan and participate in deployment of information systems they are responsible for. Generates reports and queries using SQL skills, and analyzes data to make conclusions Meet with various stakeholders including decision makers, system owners and end users to understand their business models/needs and gather requirements for new solutions. Analyze the requirements and translate them into project vision, project deliverables, business process flows, system models, detailed requirements specifications and sample data as per Knipper’s standards, policies and procedures. Provide a set of alternative solutions to address the stakeholder’s needs and achieve consensus on the solution that needs to be implemented. Lead design sessions in prototyping new systems for the purpose of enhancing business processes, operations and information process flow. Either prepare or oversee the preparation of system requirements specifications, functional design specifications, and data interface agreements

Openings: 1


Requirements:

Ability to evaluate business processes from a business and technical perspective. Experience in gathering requirements, analysis and documentation. Proven experience in overseeing the design, development, and implementation of software and hardware solutions, systems, or products. Experienced with software development methodologies/life cycles and associated processes. Experienced with object-oriented concepts, modeling, practices and procedures. Excellent analytical, mathematical, logical and creative problem-solving skills. Excellent understanding of the organization’s goals and objectives. Excellent written and oral communication skills. Excellent listening and interpersonal skills with ability to develop good working relationships. Keen attention to detail. Ability to effectively prioritize and execute tasks in a high-pressure environment. Strong customer service orientation. Experience working in a team-oriented and collaborative environment. Well versed in Microsoft Office productivity tools such as Outlook, Word, Excel, Access and/or PowerPoint. Experience with Pharmaceutical commercial data models including HCP profiles, customer target lists, rep rosters, drug sample transactions Experience with Pharmaceutical drug sample order management and distribution processes, sample accountability regulations (PDMA) and processes, touch point interactions with HCPs Health care, Pharmaceutical or life science industry experiences a plus. Knowledge of Visio or other diagramming software a plus. Knowledge of entity relationships and ability to query databases using SQL. Knowledge of MS SQL and .Net applications and development

Education:

Bachelors Degree in computer science, information systems, or a business discipline. 7+ years work experience as a business analyst with technical skills ,or as a systems analyst with business requirements experience

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Customer Service Representative - Call Center (Lawrenceville, NJ)

Job Description:

The Customer Service Representative (CSR) is an important member of the contact center team that maintains customer relationships, understands products and services, understands and researches inquiries, assembles and communicates information, verifies customers' understanding of information, answers and records customer inquiries and expands the customer base both in terms of the number of customers and in the number of products being sampled by each customer. KEY RESPONSIBILITIES: Promote meaningful relationships and brand loyalty through engaged and informed conversation with customers and sales representatives by handling incoming phone calls and emails requesting samples, literature and product information following business rules. Responsible for all initial interaction via phone and email with customers and sales representatives, including capturing profiling answers about the practice, other healthcare professionals at that practice and servicing the requests of the practice according to business rules. Answer calls, emails and requests to meet and exceed service level goals. Strive to fulfill requests during initial contact with the customer. Having the product knowledge to detail and “up sell” all products in the portfolio and to evaluate whether the customer qualifies for auto shipment according to business rules. Able to balance priorities, working with team members, between inbound calls, responding to inbound email requests and making outbound calls to messages left on voicemail. Accurately and completely capture information and update systems appropriately . Share feedback about customer and sales rep request trends and overall suggestions for improvement with supervisor. Handle potentially negative situations with customers and sales representatives with tact and diplomacy. Be flexible, organized and able to comply with constantly changing business rules about processes, products and literature offerings. Investigate issues that cannot be resolved at the time of the initial call and follow through until issue resolution. Understand when an issue must be escalated and to whom it should be escalated. Make outbound calls for other reasons as required. Find in the systems and provide availability, tracking and shipping information as needed. Assist department with additional duties as directed by the Manager and provide timely completion of special tasks when requested. The above duties are meant to be representative of the position and not all-inclusive.

Openings: 1


Requirements:

1-2 years of customer service experience in a call center or similar environment Work in the medical or pharmaceutical area a plus. KNOWLEDGE, SKILLS & ABILITIES: Excellent Written and Oral Communication Skills. Active listening skills. Able to quickly establish rapport/relationships on phone instill trust and confidence on phone. Must be able to demonstrate ability to think on your feet, fill empty space with relevant discussion. Must demonstrate a true passion for speaking with people, cannot be shy in conversations. Able to present a positive spin on disappointing news. High Productivity. Focus on the Customer . Desire for Continuous Learning. Ability to work independently and as a productive part of the Customer Service Team with little direction from the Manager. Adaptable, flexible and readily adjusts to changing departmental and business needs. Computer literate with Microsoft Office, including Outlook. Ability to multi-task. Able to deal with frustrated and angry customers. Able to prioritize own work depending on call and email volume.

Education:

High School Diploma or equivalent.

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Sample Accountability Coordinator - (Somerset, NJ)

Job Description:

The primary function of the Sample Accountability Support Coordinator is to support one or more Client Field Sales Forces with Sample Accountability related requests and to support the internal Sample Accountability team. This position requires an individual that is well organized and can work independently or in a team-oriented environment. The Sample Accountability Coordinator role requires good communication skills, both written and verbal, as well as an attention to detail. On a daily basis, review, coordinate and maintain business activities with managers and analysts. Prepare folders and maintain filing of PDMA documentation, records, manuals for regulatory purposes. Document storage and retrieval. Perform daily quality control checks on scanned and data entered documents. Receive error corrections and enter them in the system database. Provide copies to Data Entry to scan image with corrections. Fax and copy all documentation. Distribute monthly reports. Maintain active roster of all Client Field Representatives per project(s). Perform data entry of sample related transactions including sample shipments, acknowledgements of delivery, sample transfers, sample returns, and periodic inventories as designated by each client. Communicate with field personnel (Representatives/District and Region Managers, etc.) via phone, e-mail, or fax to maintain compliance in all aspects of PDMA regulations. Maintain and process signature audit data and letters as per client specifications.

Openings: 2


Requirements:

Basic math skills. Experience with and knowledge of PDMA/FDA regulations is a plus. Working knowledge of Microsoft Office Excel and Word. Excellent organizational and data entry skills. Detail orientation with computer knowledge and good customer service awareness.

Education:

Two years college degree or High School diploma plus three years work experience

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Distribution Supervisor (Charlestown, Indiana)

Job Description:

This position is responsible for the effective hands-on supervision of warehouse, shipping, inventory replenishment, cycle counting, returns and receiving activities and personnel. Direct oversight of day-to-day activities ensuring compliance with all relevant procedures and regulations. Directs workforce to complete assigned tasks, sets priorities and reallocates resources as necessary, serves as the main point of contact for team deliverables and the assignment of ad-hoc requests. KEY RESPONSIBILITIES: Maintain a safe work environment for all associates. Communicate tasks and expected turnaround. Ensure priorities are assigned to meet service levels and are in alignment with standard operating procedures, good manufacturing practices, OSHA, and inventory management best practices. Work directly with the Warehouse Operations Manager in coordination with other department Supervisors to understand daily priorities, and appropriately communicate to warehouse associates. Oversee timely completion of assigned tasks and ensure their quality. Oversee all shipping activities including documentation for hazmat and international shipments. Oversee all receiving activities and report any seal issues, temperature excursions or inventory discrepancies to QA and Warehouse Management. Interact directly with QA, Human Resources, and Facilities to effectively supervise activities. Support the execution of physical inventories and scheduled daily cycle counts to ensure company commitments can be achieved. Maintain warehouse in a clean, organized fashion in accordance with cGMP’s and Standard Operating Procedures. Perform scheduled warehouse inspections to ensure compliance with standards. Ensure forklift operators, leads, and all warehouse support personnel comply with safety protocols. Coordinate incoming and outgoing material flow to meet deadlines and service levels. Ensure the accurate and timely handling of returned goods. Identify areas for improvement, recommends changes to departmental processes and procedures. May participate in the development of standards operating/quality procedures. Resolves personnel problems by analyzing data, investigating issues, identifying solutions, and recommending action. Promote cooperation, teamwork and open communication company-wide by providing assistance to all departments as needed. Execute cycle counting program in accordance with SOP’s including coaching and training of new employees. Investigate any cycle count discrepancies and elevate to Management. The above duties are meant to be representative of the position and not all-inclusive. SUPERVISORY REQUIREMENTS: Will carry out supervisory responsibilities in accordance with the company’s policies and applicable laws. Responsibilities include: training, planning, assigning and directing work; appraising performance; motivating, developing and disciplining employees; addressing complaints and resolving conflicts. KNOWLEDGE, SKILLS & ABILITIES: Excellent verbal & written communication skills. Knowledge of WMS (Warehouse Management System) & TMS (Time Management System) Proficient in use of Excel, Word, Outlook & PowerPoint Good organization skills Good communication and interpersonal skills Lifting (50 – 70) lbs

Openings: 1


Requirements:

Business Experience: Five years of inventory/warehouse with at least two years in a supervisor position.

Education:

Two year degree preferred, High School Diploma acceptable.

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Material Handler/Forklift Operator 11:30 am - 8 pm (Lakewood, NJ)

Job Description:

POSITION SUMMARY: This is a Temporary position. The associate is certified in the safe operation of assorted material handling equipment. Able to complete duties as directed by management both accurately and in a timely manner. KEY RESPONSIBILITIES: Maintains a safe work environment at all times. Reports any unsafe issues to the supervisor. Focus on quality and accuracy as part of the company wide goal: Quality First Display: Caring, Honesty, Accountability, Respect, and Trust (CHART). Maintains a clean work environment at all times in accordance with sanitation standard operating procedures. Expected to maintain good general housekeeping practices throughout the facilities. Reports any sanitation issues to the supervisor. Participate in user training that is led by qualified staff members that will include but is not limited to: hands on the job training, material handling safe practices, Warehouse Management System (WMS) navigation, and Standard Operating Procedures (SOP) training. Said trainings are documented accordingly. Certified to safely operate material handling equipment in various areas and various applications. Some of the equipment types are: sit down counter balance, deep reach truck, order selector, turret truck, and electric pallet jacks. Equipment can be expected to be utilized in standard aisle configurations, wire guided configurations, and in refrigerated configurations. The equipment will be utilized for inbound trailer unloading, put away of stock, movement of stock, cycle counting of stock, picking of stock, and outbound loading of trailers and LTL. Those with company authorization may be qualified to drive company vehicles such as box truck and vans. Said vehicles can be expected to be driven between facility sites, special deliveries, vendor applications, and post office deliveries. As directed by the WMS, users will be expected to follow the system direction to complete daily activities. Activities are done by utilizing the WMS through either radio frequency (RF) equipment, pick to light technologies, or computer based work stations. Users can be expected to work within various areas of distribution such as: Receiving, assorted pick modules, Kitting, Shipping, Returns, DEA, freezer, and refrigerated space. Assorted WMS tasks such as receiving incoming materials, counting, sorting, verification of item numbers, lot numbers, expiration dates, counting, data entering, and other visual verifications will be conducted frequently. Along with WMS functions, other software applications such as UPS, FedEx, USPS, and shipment End of Day processes will be used daily. Expected to assist with the training of new employees. Perform other assigned tasks as directed by management.

Openings: 2


Requirements:

Must be forklift certified. Must be proficient in MS Excel and use of scale counter. Basic math skills are necessary. Knowledge of WMS (Warehouse Management System). Must be able to lift 50 to 70 pounds. One year related experience and/or training.

Education:

High school diploma or general education degree (GED).

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Compliance Analyst (Lakewood, NJ)

Job Description:

The Compliance Analyst works under direct supervision of the Compliance Manager or Compliance Director and is responsible for daily operations of the Regulatory Affairs and Compliance department. The Compliance Analyst operates primarily at the tactical level, but is required to know and understand FDA, DEA, HIPAA, Part 11 regulatory requirements in order to effectively support company compliance activities on a day-to-day basis. KEY RESPONSIBILITIES: Support the creation and management of department priority lists required to coordinate departmental work flow with Regulatory Affairs and Compliance management. Executes needed deliverables such as client requests, internal compliance queries and agency requests in a timely and efficient manner. Researches and analyzes regulations and laws relevant to Knipper operations and client programs to alert Regulatory Affairs and Compliance management to review, evaluate potential impact to compliance of these regulatory and legal requirements. Assists Regulatory Affairs and Compliance management with projects and follow up as needed. Serves as back-up for Compliance Manager or Compliance Director. Leads the Compliance Coordinators for the management of manual adjudication/prescriber validation services. Works with Professional Services and Sample Accountability on fact-gathering and PDMA investigations for incidents related to drug sample losses, thefts, concealed shortages, open AOCs, signature verification audits and sales rep activities. Drafts investigational summaries and compliance reports for client and agency submissions related to: Thefts Significant Losses and Concealed Losses Losses in Transit Negative AOCs Negative Signature Audits Falsification of Records Non-compliance by Sales Representatives Assists Regulatory Affairs and Compliance management on incident analysis and trending. Conducts internal audits Handles any updates to company’s mid-level prescriptive authority table for Rx and DEA sampling (review FDA, DEA, HHS websites, state websites, and SHALL) Handles any updates to company’s State Loss / Theft Reporting Aids Compliance Manager in monitoring changes to PDMA requirements and state requirements for drug sampling and sales representative activities. Monitors the PDMA Alliance website and regulatory database (i.e. SHALL) for legislative and regulatory updates. Conducts regulatory research and preliminary analysis on federal and state investigation and reporting requirements. Conducts regulatory research on mid-level prescriptive authority. Assists with preparation of materials for client audits alongside Compliance Administrator. Assists with preparation of training materials for sales reps alongside Compliance Administrator. Maintains client-related Regulatory Affairs and Compliance files alongside Compliance Administrator. Document archiving as required alongside Compliance Administrator. Maintains Resource hours accurately to capture billable, non-billable and overtime hours. Schedule/assist/conduct Annual Regulatory trainings for employees.

Openings: 1


Requirements:

Minimum two (2) to four (4) years legal or compliance administrative background or legal/compliance support work experience. Experience within the pharmaceutical industry and/or pharmaceutical distribution and warehousing is highly desirable. Computer literate: MS Office, Excel, and Word; basic understanding of data processing, ability to learn new business and customer management software/systems. Effective written and verbal communication, organizational and data entry skills. Detail oriented and has computer knowledge and good customer service awareness.

Education:

Associates Degree at a minimum.

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Warehouse Forklift Operator (8:00-4:30 pm) Charlestown, IN.

Job Description:

POSITION SUMMARY: To efficiently execute the physical movement of all materials while operating various types of material handling equipment and adhering to safety protocols and standard operating procedures. Material handling equipment may include: sit downs, stand-up reach truck, swing reach, order picker, pallet jacks and walkie-riders. KEY RESPONSIBILITIES: Complete daily forklift inspections as required by OSHA Complete battery watering as specified in SOP Unload inbound shipments safely and move product to designated staging area Assorted WMS tasks such as receiving incoming materials, counting, sorting, verification of item numbers, lot numbers, expiration dates, counting, data entering, and other visual verifications will be conducted frequently. Perform pallet inspections on all inbound shipments to ensure pallets are in good condition/heat treated before put-away. Swap out damaged pallets. Utilize an RF handheld device to execute picking/put-away of materials in warehouse and cold chain areas, and other inventory moves Perform flow rack replenishments to support distribution activities Ensure all inbound and outbound pallets are accurate and free of damage Report any inventory variances to Supervisor Move pallets from drop zones and staging areas to shipping or other areas as directed by Supervisor Operate and maintain material handling equipment in a safe manner. Follow cGMP documentation practices.Maintain clean and organized aisles; pallets squared off in locations, remove hanging stretch-wrap and other trash Adhere to all security requirements in the facility Attention to detail on picks, verifying item descriptions, lot numbers and expiration dates Perform physical inventory counts at specified intervals. Assist in loading and unloading of shipments.

Openings: 0


Requirements:

KNOWLEDGE, SKILLS & ABILITIES: General warehouse or manufacturing skills Use of job specific machinery and equipment General ability to operate machinery Basic computer skills Manhattan SCALE experience a plus PHYSICAL DEMANDS: While performing the duties of this job the employee is: Frequently required to stand or sit. Frequently required to stoop, kneel, or crouch. Frequently required to reach with hands and arms. Frequently lift and/or move objects up to 35 pounds. Occasionally lift and/or move objects up to 60 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education:

Education/Training: High School Education Business Experience: One year related experience or training. Experience on Raymond trucks a plus.

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Operations Lead (8-4:30 pm) Charlestown, IN.

Job Description:

POSITION SUMMARY: The Operations Lead will focus on the safety, quality and productivity of associates engaged in Operations activities assigned to them. Oversee pick pack operations in a Pick-to-Light environment. Oversee pick pack operations in a refrigerated environment. Maintain a safe Operations environment. Review the Operations Work Instructions specific to each job they are overseeing prior to running the line. Responsible for performing in-process inspections to ensure order accuracy on pick pack lines Ensure equipment is utilized as intended by the manufacturer with all guards and safety devices in place. Ensure compliance with all applicable regulations, best practices, and Standard Operating Procedures (e.g. line clearance, inventory reconciliation, current Good Manufacturing Practices (cGMP), and OSHA.) Directly responsible for meeting distribution deadlines and the productivity of the line and pick pack operators under their supervision. Responsible for coordinating cycle counts with the Distribution Leads Responsible for appropriate escalation of any incidents related to inventory or quality Deploy labor, equipment, and systems focused on achieving benchmarks and productivity requirements for assigned job(s). Accurately report the consumption of resources (e.g., labor, materials, inventory, equipment, postage, etc…) Ensure that paperwork and databases are updated and contain accurate and up-to-date information. Assign individual tasks to associates; assess quality and productivity of output on an on-going basis, making adjustments to line and labor as necessary. Participate in all training and process improvement initiatives. The above duties are meant to be representative of the position and not all-inclusive. KEY RESPONSIBILITIES: Supervisory Management 1. This position is responsible for following the directions of the Operations Supervisor, Operations Manager and other members of the Knipper Operations Management team. 2. This position is responsible for reporting back to the Operations Supervisor and Operations Manager on any and all situations that require escalation to management.

Openings: 1


Requirements:

KNOWLEDGE, SKILLS & ABILITIES: Basic Supervisory Skills or training (including safety and regulatory specific training or experience) General warehouse or distribution skills Previous experience with Pick to Light picking WMS experience a plus Use of job specific machinery and equipment Basic to intermediate mathematical skills (counting, adding, multiplying, percentages, calculating line rates, capacities, etc.) Basic to intermediate computer skills PHYSICAL DEMANDS: While performing the duties of this job the employee is: Frequently required to stand or sit. Frequently required to stoop, kneel, or crouch. Frequently required to reach with hands and arms. Frequently lift and/or move objects up to 20 pounds. Occasionally lift and/or move objects up to 35 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education:

Education/Training: High School Education or higher. Business Experience: One year related supervisory experience or training; or equivalent combination of education and experience.

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Distribution Lead (8-4:30 pm) Charlestown, IN.

Job Description:

POSITION SUMMARY: The Distribution Lead will be responsible for all job functions related to receiving, shipping and returns processing. KEY RESPONSIBILITIES: Maintain a safe distribution/production environment. Ensure compliance with applicable regulations, Knipper Standard Operating Procedures, OSHA, DOT, and industry best practices. Monitor schedule for incoming trucks and report any no-shows to Supervisor. Screen all truck drivers, verifying driver identification. Verify counts of all inventory received against packing slip/BOL for all receipts. Check for damaged inventory, and document accordingly. Complete all receiving documentation and accurately enter into WMS. All documentation will be neat, legible and free of cGMP errors. Coordinate incoming inspections with Quality Assurance and ensure inventory is appropriately staged to facilitate inspection. Stow all cold chain inventory upon receipt, completing verification of receipt and counts within the refrigeration staging area. Complete dock to stock requirements within 24 hours. Coordinate pickups with small package carriers as needed. Verify counts of packages staged in shipping & ensure accurate loading onto appropriate carrier. Run all End of Day processes to ensure UPS and FedEx shipping information has been transmitted. Complete HAZMAT and International shipping documentation for carriers as needed. Complete daily cycle counts in flow rack area to support picking activities. Returns processing & put-away in Quarantine Cage. Ensure all paperwork and databases are updated and contain neat, accurate and up-to-date information. Participate in all training and process improvement initiatives. Operate sit down forklift, reach truck, pallet jack and walkie-riders as needed. Returns processing. Quarantine preparation for destruction. Supervisory Management: This position is responsible for reporting back to the Distribution/Operations Supervisors, Production Manager(s) on any and all situations that require escalation to management. The above duties are meant to be representative of the position and not all-inclusive.

Openings: 0


Requirements:

KNOWLEDGE, SKILLS & ABILITIES: Basic Supervisory Skills or training (including safety and regulatory specific training or experience) General warehouse or distribution skills Use of job specific machinery and equipment Basic to intermediate mathematical skills (counting, adding, multiplying, percentages, calculating line rates, capacities, etc.) Basic to intermediate computer skills WMS experience required – Manhattan SCALE experience a plus Sit down forklift, and walkie rider Neat and legible handwriting PHYSICAL DEMANDS: While performing the duties of this job the employee is: Frequently required to stand or sit. Frequently required to stoop, kneel, or crouch. Frequently required to reach with hands and arms. Frequently lift and/or move objects up to 25 pounds. Occasionally lift and/or move objects up to 35 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education:

Education/Training: High School Education or higher. Business Experience: One year related supervisory experience or training; or equivalent combination of education and experience.

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Sample Accountability Technical Support Specialist (Somerset, NJ)

Job Description:

POSITION SUMMARY: The Sample Accountability Technical Support Specialist will serve as the technical and business process liaison between the Sample Accountability Department (SA), Information Technology (IT), Software Engineering (SE), and other departments within the organization. Responsibilities include maximizing current analytical tools, creating complex Excel spreadsheets and PowerPoint presentations, and building Access databases, all with a high-level of proficiency, and with adherence to the Prescription Drug Marketing Act (PDMA), client business rules, work instructions and internal corporate policies and procedures. This position will supervise one or more direct reports. KEY RESPONSIBILITIES: Supervises the work of the Sample Accountability Technical Support Coordinator in support of the Sample Accountability Department and SA client teams, which includes, but is not limited to, mentoring and providing direction and guidance, monitoring and approving work hours in the TimeTrak and ReSource Systems, and administering the mid-year and year-end review. Oversees the daily tasks and deliverables assigned to the SA Technical Team, ensuring all deadlines are met with a high level of accuracy, which includes the daily review of the SA Tech email box. Analyzes Call/eMail Log data, and implements enhancements. Updates Call/email Log metrics ensuring accuracy, provides reporting to SA client teams. Subject matter expert supporting the sample accountability business intelligence system, which includes understanding client requirements, building and revising reports/cards, creating training presentations, training internal stakeholders and client Teams. Learns existing systems, and serves as the subject matter expert for the Sample Accountability Department and SA Technical Support Coordinator, which includes creating training presentations and training internal stakeholders. Creates/updates systems and/or business-related work instructions, FAQs, and provides trainings. Liaison between Software Engineering (SE), Information Technology (IT), Data Entry (DE) and other internal teams in support of the SA Department and SA clients. Researches technical and process issues related to the Sample Accountability Systems (PharmaComply, SIMS), the SA Department and/or SA client teams, and provides solutions. Reviews existing business and system processes periodically to build efficiencies, creates new processes, where applicable. Utilizes Access, Excel, and other systems to update or build complex reports, trackers and forms in support of the Sample Accountability Department and SA client teams. Provides training and creates training presentations and work instructions. Creates PowerPoint presentations, charts and graphs upon request by the SA Department in preparation for client Quarterly Business Reviews (QBRs) and miscellaneous internal and client presentations and meetings. Creates and updates department work orders and work instructions to ensure all aspects of the task, process and system are accurately conveyed. Generates Change Requests (CR), Project Management (PM) tickets and ScoreCards in support of system research, updates and changes, and provides all follow-up until the work is completed. Performs ad hoc system, process and administrative tasks as scheduled and upon request. Trouble shoots issues pertaining to the Sample Accountability Systems (PharmaComply, SIMS), which includes providing user access. Generates signature verification letters, reconciliation reports and miscellaneous reports in support of the Sample Accountability Department and SA clients. Oversees the ordering and maintenance of supplies for the Sample Accountability Department. The above duties are meant to be representative of the position and not all-inclusive. KNOWLEDGE, SKILLS & ABILITIES: Quick learner with proven computer and systems aptitude and experience. Strong organizational and planning skills. Strong interpersonal, communication, and writing skills. Supervisory skills with the ability to delegate work as needed, ensuring all work is clearly understood, completed accurately and on time. Strong analytical skills, with a high-level of accuracy. Ability to proactively anticipate issues. Strong knowledge of Microsoft Office; Outlook, Word and Excel (Pivot Tables Charts, Graphs, etc.) Proficiency in Microsoft Access. Working knowledge of Microsoft Project a plus. Ability to make decisions using sound judgment. Maintains professionalism in a deadline-driven environment. Ability to multitask across various client teams and projects. Ability to proactively troubleshoot and identify system issues, and present suggested resolutions. Detail oriented. Strong time-management and prioritization skills. Punctual, dependable with a positive attitude. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Openings: 1


Requirements:

Experience in a technical/business environment. Demonstrated capability to supervise effectively, to analyze data (trending, projections, reporting, etc.) and to communicate and interact with all levels of the organization. Experience prioritizing and delegating work using sound judgment, often times with competing and changing priorities.

Education:

Associates Degree or equivalent certificate training or experience.

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Quality Assurance Associate (Charlestown, IN)

Job Description:

POSITION SUMMARY: Performs all routine review and inspections of assembly, fulfillment, print, and receiving functions. Enforces compliance with SOP’s, cGMP, work order instructions, and all safety measures. Reports all non-conformances to management. KEY RESPONSIBILITIES: Assembly Line Clearance and Start up – assure appropriate materials/products are present for a job, paperwork is reviewed and understood, line set-up complies with cGMP and Standard Operating Procedures. This includes first piece inspection for conformance to written specifications (Work Order) and sample. Review reconciliation of product and/or components in assembly and fulfillment. This includes review and sign-off on Quality documentations and reconciliations. Monitors inventory, lot numbers, expirations dates, and checks orders in fulfillment areas to assure accuracy. Conducts and records the results of on-line inspections of packaging lines. Conducts and records the results of on-line inspections of materials printed or produced in-house. Maintain QA metrics database of non-conformances in Assembly, Print, and Inbound products. Reviews and maintains all quality control paperwork involved with incoming inspections and inspection log. Inspect inbound materials in accordance with ANSI/ASQC Z1.4 standards. Monitor portable temperature recording equipment and change charts on a weekly basis. Train on and maintain knowledge of Quality Assurance and applicable Knipper SOP’s. Train on and maintain knowledge of client SOP’s where applicable. Review and maintain all Work Orders generated by Operations. Review and maintain all Wave Reports generated by Operations or Warehouse Escort vendors for pest control, scale calibration and environmental monitoring. Perform responsibilities in all Knipper facilities. The above duties are meant to be representative of the position and not all-inclusive.

Openings: 1


Requirements:

KNOWLEDGE, SKILLS & ABILITIES: Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate, ratio and percent. Working knowledge of current Good Manufacturing Practices. PHYSICAL DEMANDS: While performing the duties of this job the employee is: Frequently required to stand or sit. Frequently required to stoop, kneel, or crouch. Frequently required to reach with hands and arms. Frequently lift and/or move objects up to 20 pounds. Occasionally lift and/or move objects up to 35 pounds.

Education:

High School Education or general education degree minimum. Three months prior QA experience.

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Quality Assurance Director (Lakewood, NJ)

Job Description:

The Director of Quality Assurance (“Director”) will lead the implementation of business control systems and assist the Senior Management team in meeting quality expectations. In this leadership capacity, the Director will function as internal auditor, ensuring compliance with Good Manufacturing Practices as well as a broad range of federal and state policies, procedures and regulations relating to drug, device and food warehousing and distribution operations. The Director is responsible for strategic risk assessments of support functions to identify areas of highest risk and to prevent potential liability to the Company. The Director identifies gaps, inefficiencies, and inconsistencies in internal systems, and creates appropriate common systems to ensure compliance across Knipper’s warehousing facilities. The Director oversees all Quality functions; development and implementation of the Quality Management System (“QMS”), shaping and establishing quality standards of products and performance; tracking, reviewing and approving internal documentation and customer deliverables; providing input to and monitoring corrective actions; and internal quality training. Essential Duties and Responsibilities include the following. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Undertake the leadership responsibility for quality assurance by creating and implementing a system for on-going evaluation of appropriate business processes, procedures, and controls. Perform strategic risk assessments of various projects to identify areas of highest risks and needs for controls. Provide consultative services that include process engineering and improvement, development of fiscal control plan and best practices, management of information, record management, space planning, and related functions. Oversee Quality functions ensuring that the receipt, warehousing, assembly and distribution of physician samples conform to PDMA and cGMP’s requirements, Corporate Standard Operating Procedures (SOPs) and Program Specific Operating Procedures. Recommend procedures to eliminate gaps, inefficiencies and inconsistencies in internal systems to ensure quality and compliance. Serve as the internal expert on rules and regulations relating to all quality, operations and distribution issues. Independently determine the need for legal review and/or approval for exceptions to standard operating practices and procedures. Provide guidance to staff on interpretation and implementation of policies. Monitor effectiveness of QA initiatives and CAPA plans. Develop and deliver training on QA procedures and to address critical needs, as identified through agency, client and internal audits. Establish continuous improvement systems to enhance functionality based on feedback from clients and departments. Work closely with Professional Services, Operations, IT/IS and Contact Center in meeting QA and FDA requirements. Undertake special projects; conduct analyses and make recommendations, act as inside consultant to evaluate non-routine problems, make professional written and oral presentations. Performs responsibilities in a professional manner, meeting the Company’s CHART principles, mission and goals. Supervisory Responsibilities This job has supervisory responsibilities. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Computer Skills To perform this job successfully, an individual should have knowledge of Accounting software; Contact Management systems; Database software; Human Resource systems; Internet software; Inventory software; Manufacturing software; Order Processing systems; Project Management software; Spreadsheet software and Word Processing software and/or demonstrable proficiency with the Microsoft Office suite of products. Certificates, Licenses, Registrations Other Skills and Abilities Must be skilled at conducting strategic risk assessments and implementing solutions to address critical needs. Must have strong persuasive abilities to influence cooperation and compliance with work methodologies without direct reporting authority. Must have demonstrable ability to work as a member of a team and to provide expertise to a large multi-functional staff. Must have experience in developing, writing, and communicating internal policies and procedures. The Director will be effective at solving problems, not just defining them. The Director will have demonstrable training skill – one-on-one or before groups.

Openings: 1


Requirements:

Extensive experience in compliance management and a broad understanding of regulations relating to the pharmaceutical industry across many federal and state agencies, private industry, and other organizations required. In-depth knowledge of Company policies and regulations, and the intricate and often delicate complex interactions between business units will be required of the Director. Must have an understanding of the principles and an in-depth knowledge of applicable federal rules and regulations. Must have knowledge of regulations and safety practices related to Company product. Must demonstrate expertise in conducting internal audits and recommending improved controls to assist teams in passing external audits.

Education:

Bachelor's degree (B. A.) from four (4) year college or university; or ten (ten) or more years related experience and/or training; or equivalent combination of education and experience required. Master’s Degree in Business Administration or similar preferred.

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