QA Associate ; Biotechnology Industry

Title: QA Associate I ) – Biotechnology Industry

Location: Kentucky, U.S. (Open to local residents in Kentucky)

Positions: 1

Duration: Approximately 7 months contract (Temp-to-Hire)

Shift: Monday–Friday, 2:00 PM – 10:30 PM, with occasional overtime

Work Type: Onsite

• Recommend changes to SOPs and batch records as needed.
• Review proposed SOP revisions and provide feedback to management.
• Conduct real-time audits of batch records in production suites for completeness, documentation accuracy, calculation errors, and adherence to critical process parameters.
• Perform room and equipment clearances according to procedure following production cleaning.
• Conduct microbial swabbing of equipment and room surfaces for environmental monitoring.
• Maintain full understanding of all client SOPs, policies, and applicable cGMP and CFR guidance for manufacturing 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.
• Monitor production areas for compliance with SOPs, cGMP, batch records, and safety requirements to identify and resolve errors and prevent deviations.
• Work cross-functionally to assess potential deviations and assist in determining whether an investigation is required.
• Initiate deviation problem reports in Trackwise, documenting incidents for full investigation by the responsible department.
• Manage quality status of WIP and finished goods in physical inventory and inventory systems (JD Edwards).
• Assist in investigations of deviations by supporting data collection and root cause analysis.
• Enforce GMP compliance throughout the site.
• Promote teamwork and effective communication within the department.
• Provide training and coaching to manufacturing staff as needed.
• Support process improvement initiatives, including training, efficiency projects, and CAPA implementation.
• Complete investigations of customer complaints.
• Perform other duties as required to support high-performance quality operations.

• Lead investigations, write reports, conduct root cause analysis, and implement CAPAs for deviations assigned to QA.
• Supervise training of new QA employees.
• Analyze historical trends and provide awareness training to QA staff on potential documentation errors.
• Represent QA in projects and cross-functional meetings.
• Assist the Regulatory group in internal audits of other functional areas.
• Serve as a customer-facing QA contact when required.
• Develop new procedures as needed.
• Perform additional duties to support high-performance QA operations.

• Bachelor’s degree; OR
• Associate degree with 1 year of related experience; OR
• High School Diploma/GED with 2 years of related experience

Prospective candidates are encouraged to apply by submitting an updated resume directly through the [job description link] to be considered for this opportunity.