GMP Quality Assurance Analyst — Investigations & Release

Lancesoft; Philadelphia (Philadelphia County); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Lancesoft is seeking a QA Analytical Specialist to review QC testing records and OOS investigations, working with QA, QC, and Manufacturing to ensure GMP compliance. The role involves oversight of QC testing and investigations, review of batch records, and approval of analytical results and CoAs for materials destined for clinical or commercial use.

The ideal candidate will have a BS/BA in a related science, 2–5 years in pharma/biotech, GMP experience, and strong technical writing and

Competenze

• BS/BA required in Biology, Chemistry, Engineering or related science.
• 2-5 years pharma/biotech experience; 1-2+ years analytical experience in a lab operations environment preferred.
• GMP experience required; knowledge of USP/EP/ICH and FDA guidelines.
• Strong communication and technical writing skills for investigation reports.

Mansioni

• Review and approve QC testing records and OOS investigations.
• Oversee QC testing and investigations; review batch records for product disposition.
• Review CoA and ensure testing compliance across materials and products.
• Contribute to investigations/deviations and CAPAs; assist in audits and regulatory inspections.

Conoscenze

Analytical testing

GMP compliance

Technical writing

Investigations & CAPA

Record review

Quality systems

Communication

Formazione

BS/BA in Biology/Chemistry/Engineering

Strumenti

Analytical instruments

Descrizione del lavoro

Lancesoft is seeking a QA Analytical Specialist to review QC testing records and OOS investigations, working with QA, QC, and Manufacturing to ensure GMP compliance. The role involves oversight of QC testing and investigations, review of batch records, and approval of analytical results and CoAs for materials destined for clinical or commercial use.

The ideal candidate will have a BS/BA in a related science, 2–5 years in pharma/biotech, GMP experience, and strong technical writing and