QA Analytical Specialist
Location: Philadelphia, PA 19104 (Onsite)
Duration: 12-Month Contract
Pay Rate: $54.29/hr.
Job Overview:
We are seeking a QA Analytical Specialist with pharmaceutical or biotechnology industry experience to support GMP quality operations, analytical testing, QC investigations, and product release activities. The ideal candidate will have hands-on knowledge of GMP quality systems, CAPA, deviations, change controls, and analytical laboratory operations.
Key Responsibilities
- Review and approve analytical and microbiology testing records for raw materials, drug substances, and drug products.
- Support QC investigations, deviations, change controls, and CAPA activities.
- Review batch records, laboratory documentation, and Certificates of Analysis.
- Evaluate analytical results against approved specifications and support product disposition.
- Prepare, review, and revise SOPs and investigation reports.
- Support material inspections, vendor certificate reviews, internal audits, and regulatory inspections.
- Ensure compliance with GMP requirements and applicable FDA, USP, EP, and ICH guidelines.
Required Qualifications:
- Bachelor's degree in Biology, Chemistry, Engineering, or a related scientific discipline.
- 2–5 years of pharmaceutical or biotechnology industry experience.
- GMP environment experience is required.
- 1–2+ years of analytical laboratory or QC experience preferred.
- Knowledge of analytical testing methods, laboratory equipment, and quality systems.
- Experience with CAPA, deviations, investigations, and change controls.
- Strong technical writing, documentation, communication, and problem-solving skills.
Preferred Qualifications:
- Experience with batch record review and product disposition.
- Experience working with contract testing laboratories and external partners.
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