QA Analytical Specialist - GMP Quality Assurance Expert

Virtual Company; Philadelphia (Philadelphia County); On-site; USD 51,000 - 76,000; Full time

Job summary

The Fountain Group is seeking a QA Analytical Specialist to support GMP-compliant QA activities in Philadelphia, PA. You will review and approve QC analytical testing records, investigate deviations, and ensure batch documentation meets regulatory requirements.

You will collaborate across QA and manufacturing, monitor testing trends, assist with internal and external audits, and contribute to timely product disposition and regulatory readiness.

Qualifications

• Bachelor's degree in biology, chemistry, engineering, or a related scientific discipline.
• 2–5 years of experience in the pharmaceutical or biotechnology industry.
• Experience with GMP compliance and QC analytical testing.

Responsibilities

• Review and approve analytical and microbiology testing records for raw materials, bulk drug substances, and drug products.
• Review and approve Out-of-Specification (OOS) investigations, deviations, change controls, and CAPAs.
• Evaluate analytical results against approved specifications and determine material and product disposition.
• Review executed batch records for drug substances, drug products, and packaged materials.
• Provide QA support for laboratory investigations, analytical testing issues, and manufacturing deviations.
• Review and approve SOPs, vendor certificates, and Certificates of Analysis (CoAs).
• Monitor analytical testing trends and identify potential quality issues.
• Support internal and external audits and regulatory inspections.

Skills

GMP compliance

QC analytical testing

QA/QC processes

OOS investigations

Deviation management

CAPA

Change control

Analytical data review

Batch record review

Education

Bachelor's degree in Biology, Chemistry, Engineering, or a related scientific discipline

Job description

The Fountain Group is seeking a QA Analytical Specialist to support GMP-compliant QA activities in Philadelphia, PA. You will review and approve QC analytical testing records, investigate deviations, and ensure batch documentation meets regulatory requirements.

You will collaborate across QA and manufacturing, monitor testing trends, assist with internal and external audits, and contribute to timely product disposition and regulatory readiness.