Quality Assurance Associate

Overview :

YOUR PASSION, ACTIONS & FOCUS is our StrengthBecome one of our ContributorsJoin the KnipperHEALTH Team!

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, IndianaMust be available to work the hours of 9:00am- 5:30pm 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.