Pharma QA Analyst - GMP & Analytical Records Expert

BEPC Inc. - Business Excellence Professional Consulting; Philadelphia (Philadelphia County); On-site; USD 69,000 - 75,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Job summary

BEPC Inc. in Philadelphia, PA is seeking an experienced QA Analytical Specialist to support GMP quality assurance operations for pharmaceutical and biotechnology products.

You will review QC data, approve test records, and support investigations to ensure regulatory compliance and product disposition. The role emphasizes collaboration with QA, QC, and Manufacturing teams to resolve analytical issues and maintain audit readiness, with a focus on documentation accuracy and scientific justification

Qualifications

• 2–5 years of pharmaceutical or biotechnology experience.
• Experience in GMP-regulated environment.
• Knowledge of analytical laboratory testing and QC investigations.
• Strong technical writing and documentation skills.

Responsibilities

• Review and approve QC analytical testing records and OOS investigations.
• Ensure testing performed per approved methods, specs, and filings.
• Review and approve internal/external analytical and microbiological results for materials and products.
• Verify compliance with US, EU, and international GMP requirements.
• Provide QA technical expertise to resolve analytical testing issues.
• Support investigations involving deviations, OOS results, and CAPA activities.
• Review closure of deviations, change controls, CAPAs, and quality investigations.
• Review batch records for bulk substances, drug products, and packaged lots.
• Evaluate results against specifications to support release and disposition.
• Inspect and release production materials against specs.
• Review CoAs for accuracy and compliance.
• Prepare CoAs for clinical and commercial products.
• Evaluate testing trends and identify quality concerns.
• Author and approve SOPs and other quality documents.
• Collaborate to improve GMP compliance.

Skills

GMP knowledge

QA analysis

Documentation

Cross-functional collaboration

Problem solving

Education

BS/BA in Biology, Chemistry, Engineering or related

Tools

Analytical instrumentation knowledge

Job description

BEPC Inc. in Philadelphia, PA is seeking an experienced QA Analytical Specialist to support GMP quality assurance operations for pharmaceutical and biotechnology products.

You will review QC data, approve test records, and support investigations to ensure regulatory compliance and product disposition. The role emphasizes collaboration with QA, QC, and Manufacturing teams to resolve analytical issues and maintain audit readiness, with a focus on documentation accuracy and scientific justification