QA Analytical Specialist

Our Client, a Biotech company, is looking for a QA Analytical Specialist for their Philadelphia, PA location.

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.

Requirements:

• 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.

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities