Quality Assurance Associate

Winchester, KY 40391

Posted: 11/15/2023 Employment Type: Contract Division: Life Sciences Job Number: JN -112023-17911 State: Kentucky

Job Description

Quality Assurance Associate

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

  • Title: Quality Assurance Associate
  • Location: Winchester, KY
  • Industry: Pharmaceutical
  • Hours: Sunday- Thursday 10PM - 6:30AM
  • Salary: up to $29 (Paid Weekly - Benefits Available)
  • Employment Type: 3-6 month contract (potential for extension or direct hire)

Environment: The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and SOP's through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.


  • Recommend SOP and batch record changes as needed
  • Review proposed SOP revisions and provide feedback to management
  • Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
  • Perform room and equipment clearances per procedure following cleaning conducted by production.
  • Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
  • Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.
  • Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
  • Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
  • Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
  • Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
  • Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
  • Other assignments as needed within the scope of QA Associate training curriculum.
  • Assist in investigations for deviations by supporting data gathering and root cause analysis
  • Enforcement of GMP Compliance.
  • Promotes team work and good communication.
  • Provide training and coaching to manufacturing staff as needed
  • Support site process improvements (training, efficiency projects, implementation of CAPAs)
  • Supports customer complaint investigation by performing inspection of retains and complaint samples


  • Bachelor s Degree in related science or technical field preferred with 2 years prior work experience
  • Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment.
  • Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification




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