Quality Manager III
Discovery Drive, SWDD Swiftwater, PA
This position, with direction from QV management, is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing. Requires strong Commissioning and Qualification background.
- Participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines
- Review and approve validation related studies for assigned areas. These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process
- Validation, Equipment and Facility Qualification and Validation Risk Management.
- Signatory responsibilities for validation/qualification documents within assigned areas.
- Working knowledge of cGMPs and regulatory requirements
- Experience with validation of biotech manufacturing processes (i.e. viral antigen or formulation production) and knowledge of current FDA regulations and industry guidance related to validation processes.
- Knowledge of vaccines/biologics products and associated technologies
- The ability to work on cross functional project teams
- Meet/Exceed project timelines/deliverables
- Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Office
- Strength in several LEAD Competencies - Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
5+ years’ experience in a GMP regulated environment working on validation projects associated with biotech processes and equipment.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.