QA Associate

QA Associate

Location: Winchester, KY 40391
Duration: 6 Months
Format: Onsite Role
Shift: Mon-Fri 2:00‑10:30 pm (Training: Mon‑Fri 6:00‑2:30 pm)

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 Client SOP) 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 Client 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 in 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 in 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 teamwork 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.

Education or Experience (Minimum required to perform job):

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

Knowledge/Skills Requirements:

• Familiarity with basic laboratory instrumentation.
• Safe work habits.
• Basic math and computer skills.
• Good communication skills.
• Ability to follow written and verbal instructions.
• Able to work with limited supervision for routine tasks.
• Excellent documentation and handwriting skills.
• Proficient reading and comprehension skills.
• Sound decision‑making, technical and problem‑solving skills.
• Good time management skills.
• Expert technical writing and problem‑solving skills.
• Good Laboratory Practices.
• Experienced with continuous improvement techniques.
• Demonstrates initiative.