Quality Assurance Associate

Overview

YOUR PASSION, ACTIONS & FOCUS is our Strength

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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 11:30am- 8:00pm 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.