Job Description
The Biologics Drug Substance Quality Assurance Specialist is responsible for performing key quality tasks in respect of company products. The position works in the External Manufacturing Quality Group within the Technical Operations department, which oversees contract manufacturing operations and internal quality systems.
Essential Functions/Responsibilities
* Monitoring and supporting the quality performance of contract manufacturing organizations and material suppliers to all applicable GXP standards.
* Reviewing and approving product complaints, deviations, validation protocols, change controls, and leading product-related investigations.
* Ensuring compliance of all respective contract manufacturers to both internal jazz requirements and country-specific regulations.
* Collaboration with all contract manufacturers, packagers, and testing laboratories to resolve any quality issues.
* Contributing to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers.
* Highlighting any risks associated with maintaining supply of commercial drug products to all markets.
* Conducting vendor audits and vendor site visits as required.
* Assisting in internal audits and regulatory agency inspections.
* Summarizing CMO Annual Product Quality Reviews and supporting regulatory submissions.
Required Knowledge, Skills, and Abilities
* Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/Biotechnology Industry.
* Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations.
* Deep knowledge of biologics drug substance manufacturing.
* Substantial experience working in or directly supporting manufacturing within a biologics drug substance manufacturing site.
* Experience with contract manufacturing is desirable.
* Significant experience (>5years) of commercial and/or late-state clinical phase GMP manufacturing of biologics drug substance products.
Required/Preferred Education and Licenses
* Bachelor's degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology, or a related discipline.