Quality Assurance Associate

Knipper•Charlestown, IN

8h•Onsite

About The Position

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. This is a 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.

Requirements

High School Education or general education degree minimum.
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.

Nice To Haves

Three months prior QA experience
Experience in a regulated industry.
Working knowledge of current Good Manufacturing Practices.

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