Tunnell Consulting Inc. Quality Manager - V in Framingham, Massachusetts
Quality Manager - V
Job City: Framingham
Job State: US - Massachusetts
Client Project Number: 9137
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.
Skills: Technical Competencies:
*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
*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
*5+ years' experience in a GMP regulated environment working on validation projects associated with biotech processes and equipment.