Operational Quality Specialist -QC

What you'll do

• Oversee QC quality-system activities, including deviations, CAPAs, change controls, validation, analytical method transfers, risk assessments, and PQRs; advise QC personnel on cGMP and quality issues.
• Provide on-floor QA support, review documentation and records, and manage laboratory area status and room release after return-to-service testing.
• Provide QA oversight of the site Stability and Retention program and make quality decisions affecting clinical and commercial product release.

What they ask for

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, or a related scientific discipline.
• 2+ years of quality control experience, including experience overseeing quality control testing.
• Experience with quality systems and QC laboratories, including validation, documentation, and compliance in a high-volume, rapid-turnaround release or compliance environment.
• Knowledge of GMPs and applicable regulatory requirements; strong communication, problem-solving, and cross-functional influencing skills.

Nice to have

• Experience with licensed biopharmaceutical or biological products; hands-on analytical laboratory equipment or systems experience (HPLC, GC-MS, TOC, FTIR, ELISA) and aseptic environmental monitoring or microbiological testing.
• Experience in pharmaceutical or biologics manufacturing; knowledge of LIMS or electronic lab notebooks, investigation techniques, or regulatory inspections and audit readiness.

Tools

HPLC, GC-MS, TOC, FTIR, ELISA, LIMS