QA Analytical Specialist

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

Job Title: QA Analytical Specialist
Location: Philadelphia, PA
Pay Rate: $36.96–$55.11/hour
Duration: 1 Year

Job Description

The QA Analytical Specialist will support Quality Assurance activities by reviewing and approving QC analytical testing records, laboratory investigations, and batch documentation to ensure compliance with GMP and regulatory requirements.

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.

Education

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

• 2–5 years of experience in the pharmaceutical or biotechnology industry.

Required Skills

• Good Manufacturing Practices (GMP) compliance.

• QC analytical testing and laboratory operations.

• Quality Assurance and Quality Control processes.

• Out-of-Specification (OOS) investigations.

• Deviation management, CAPA, and change control.

• Analytical data review and product disposition.

• Batch record review and quality documentation.

Preferred Skills

• 1–2+ years of analytical laboratory experience.

• Experience with analytical testing and analytical development.

• Knowledge of analytical laboratory equipment and instrumentation.

• Familiarity with USP, EP, ICH, and FDA regulatory guidelines.

• Experience with microbiology testing and pharmaceutical product release.