QA Analytical Specialist

Position Title: QA Analytical Specialist
Work Location: 3737 Market Street, Suite 1300, Philadelphia, Pennsylvania
Assignment Duration: 12 months

Position Summary:

• The QA Analytical Specialist will review and approve QC testing records and any associated OOS investigations while working closely with QA, QC and Manufacturing Functional Management to identify strategies, and objectives for improvement to GMP compliance.
• The incumbent will oversee QC testing and investigations (both internal and external) and will review executed batch records and evaluate product and facility deviations; support conclusions as they impact product disposition at our organization.

Key Responsibilities:

• Ensure drug substance and drug product analytical testing is conducted according to approved methods and regulatory filings.
• Review and approve internal and external analytical and microbiology testing in all raw material/starting material, buffer solutions, bulk drug substance and drug product for commercial and/or clinical distribution to ensure compliance with global (US/EU/ROW) GMP requirements.
• Provide QA technical expertise for analytical testing issues that arise from QC testing.
• Participate in troubleshooting efforts of laboratory investigations/deviations that arise during the manufacture or testing of drug substance.
• Assure all Quality lab investigations, deviations, change controls, CAPAs and/or other required documentation related to the lots are completed and closed prior to material/lot release.
• Author, revise, review and approve Standard Operating Procedures as required/assigned.
• Perform inspection and release of materials used for production against the MSS.
• Review vendor certificates for completeness / compliance against approved specifications.
• Evaluate analytical results against approved specifications to determine compliance, release materials for use and/or provide an appropriate disposition for product.
• Prepare certificate of analysis (CoA) for products for clinical and/or commercial materials.
• Evaluate lot test results against trending data to identify any irregular trends.
• Conduct record review of executed batch record for bulk drug substance, drug product and packaged lots.
• Assist in the audits of internal QC groups and/or CTLs.
• Supports regulatory inspections.

Qualification & Experience:

• BS /BA in Biology, Chemistry, Engineering, or related science discipline is required.
• Generally, 2-5 years of experience in the pharmaceutical/biotechnology industry.
• Generally, 1-2+ years analytical experience within a laboratory operations environment preferred.
• Must have proven experience working in a GMP environment.
• Analytical and laboratory equipment experience and knowledge in the areas of analytical testing and/or analytical development.
• Knowledge of quality systems such as change control, investigations and CAPA.
• Ability to communicate effectively with wide range of personnel.
• Technical writing skills related to investigation reports.
• General knowledge of GMP compliance as well as USP, EP, ICH and FDA guidelines.