Quality Manager III in Swiftwater, PA at Integrated Resources, Inc

Date Posted: 1/15/2020

Job Snapshot

Job Description

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.
Key Accountabilities:
*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.

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.
Key Accountabilities:
*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
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, Delta V, 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

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