Job Description
Job Description
Responsibilities:
- Ensure drug substance and drug product analytical testing is conducted per approved methods and regulatory filings.
- Review and approve internal and external analytical and microbiology testing for raw materials, buffers, bulk drug substance, and drug product for clinical and commercial use to meet US/EU/ROW GMP requirements.
- Provide QA technical expertise for analytical testing issues arising from QC testing.
- Participate in troubleshooting of laboratory investigations and deviations during manufacture or testing of drug substance.
- Assure all quality investigations, deviations, change controls, and CAPAs related to lots are completed and closed prior to material or lot release.
- Author, revise, review, and approve Standard Operating Procedures as required or assigned.
- Perform inspection and release of materials used for production against the MSS and approved specifications.
- Review vendor certificates for completeness and compliance.
- Evaluate analytical results against specifications to determine compliance and provide appropriate disposition decisions.
- Prepare Certificates of Analysis for clinical and commercial materials.
- Assess lot results against trending data to identify irregular trends.
- Conduct record review of executed batch records for bulk drug substance, drug product, and packaged lots.
- Assist in audits of internal QC groups and contract testing laboratories.
- Support regulatory inspections.
Required Skills & Qualifications:
- BS/BA in Biology, Chemistry, Engineering, or related science discipline.
- 2–5 years of experience in the pharmaceutical or biotechnology industry.
- 1–2+ years of analytical experience within a laboratory operations environment preferred.
- Proven experience working in a GMP environment.
- Knowledge of analytical and laboratory equipment and methods used in analytical testing and development.
- Knowledge of quality systems, including change control, investigations, and CAPA.
- Effective communication skills across cross-functional teams.
- Technical writing skills for investigation reports and SOPs.
- General knowledge of GMP compliance and relevant guidelines, including USP, EP, ICH, and FDA.
\nCompany Description
BCforward is a leading workforce solutions company connecting skilled professionals with top employers nationwide. We are committed to empowering careers through meaningful opportunities, professional growth, and exceptional support throughout the employment journey.
Company Description
BCforward is a leading workforce solutions company connecting skilled professionals with top employers nationwide. We are committed to empowering careers through meaningful opportunities, professional growth, and exceptional support throughout the employment journey.