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Knipper Quality Assurance Associate in Charlestown, Indiana

POSITION SUMMARY:

Maintains quality standards by performing routine incoming, in process and finished product inspections; approving incoming materials, in-process, and finished products; recording quality results. Enforces compliance with Knipper Quality Policy, SOP’s, cGMP, Operations Work Order Instructions, and all safety measures.

KEY RESPONSIBILITIES:

  • Performs incoming material and product inspections (including returned product as necessary) in accordance with documented procedures and sampling plans.

  • Performs line clearance activities in accordance with documented procedures, including assuring that appropriate materials/products are present for a job, paperwork is reviewed and understood, line set-up complies with cGMP and company SOPs; performs first piece inspection for conformance to written specifications (Operations Work Instruction) and sample; documents the results of line clearance inspections performed.

  • Performs random and scheduled inspections of print, assembly and kitting activities in accordance with documented procedures; documents the results of such line inspections when performed.

  • Documents all inspection results by completing reports and logs; verifying same is completed by assembly personnel as required; escalates nonconformance found during incoming inspections accordingly.

  • Maintains safe and healthy work environment by following standards and procedures.

  • Updates job knowledge by participating in educational opportunities; routinely reading standard operation procedures (SOPs), Department Work Instructions (WIs) and Operations Work Instructions.

  • Accomplishes Knipper quality mission by adhering to all quality standards.

  • Reports all concerns and questions to management.

  • Review reconciliation of product and/or components in assembly and fulfillment

  • Reviews and maintains all quality assurance inspection documentation and inspection logs.

  • Reviews and maintains all quality system paperwork involved with incoming inspection, line inspections, return inspections, assembly / production, and distribution activities in conformance with good documentation practices are readily retrievable.

  • May escort vendors for pest control, scale calibration and environmental monitoring.

  • Scope of responsibilities include: RECEIVING; PRODUCTION/ASSEMBLY; MATERIAL AND PRODUCT DESTRUCTION AND RECYCLING; DEA; PRINTThis job function has no supervisory responsibilities.

The above duties are meant to be representative of the position and not all-inclusive.

MINIMUM JOB REQUIREMENTS:

Education/Training: High School Education or general education degree minimum.

Preferred: Three months prior QA experience; experience in a regulated industry.

KNOWLEDGE, SKILLS & ABILITIES:

  • Good written and oral communication skills.

  • Basic computer knowledge.

  • Ability to use a calculator to perform basic math functions and understands the concept of same including: add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals; compute ratio, rate and percent.

  • Ability to carefully monitor activities using as appropriate, instruments, gauges and processes.

  • Preferred: 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.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

ID: 2020-1804

Street: 1250 Patrol Road

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