Responsibilities
- Establishes and executes batch release processes for gene therapy drug substances, drug products, master cell banks, plasmids, and finished goods produced at the Hopewell, NJ facility.
- Prepares and issues compliance documentation including Certificates of Conformance, Certificates of Analysis, and BSE/TSE declarations.
- Creates and oversees quality assurance processes for cell bank and plasmid release, usage, and lifecycle management.
- Manages quality assurance oversight of area release and line clearance procedures in ProBio areas, including facility walkthroughs.
- Supervises QA review and approval of calibration records for GMP equipment and instruments within Maximo.
- Provides support during internal and external audits to ensure adherence to current GMP standards.
- Conducts or manages on-site QA activities during critical operations such as cell bank receipt, manufacturing, filling, labeling, inspection, packaging, warehousing, and shipping.
- Oversees document control functions, including approval of local electronic documents like SOPs, standards, forms, work instructions, master batch records, and specifications.
- Designs and implements site-specific procedures for managing drug product label proofs, printed labels, and reconciliation of unused or damaged labels.
- Administers Veeva Vault system across all applicable Veeva Vault applications.
- Supports engagement with regulatory agencies on matters related to manufacturing quality, compliance policies, and quality systems.
- Proposes improvements to quality systems to strengthen performance and collaborates with cross-functional teams to implement changes.
