What are the responsibilities and job description for the Quality Assurance Associate position at Knipper HEALTH?
Overview
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The Quality Assurance Associate, 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.
Full Time 100% On-site Role, Based out of Charlestown, Indiana
Must be available to work the hours of 8:00am- 4:30pm ET Monday-Friday.
Previous quality assurance experience preferred.
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; PRINT
- This job function has no supervisory responsibilities.
The above duties are meant to be representative of the position and not all-inclusive.
Qualifications
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 to include: Outlook, Word, Excel, etc.
- 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.
Knipper Health is an equal opportunity employer.
