The Center for Breakthrough Medicines QA Department is seeking a QA Validation Specialist responsible for providing quality oversight of the validation and qualiﬁcation activities for manufacturing process, facility, equipment, and systems within a Cell and Gene Therapy manufacturing facility supporting both clinical and commercial programs in a sterile GMP environment. This role will be responsible for reviewing and approving validation/qualiﬁcation protocols/reports, standard operating procedures, investigations, work orders, change documents, reports for projects and maintenance activities.
- Work in a collaborative team setting with quality counterparts that include Manufacturing Operations, Engineering and Validation, Quality Control, Operations Technical Support, Testing, Supply Chain, and Planning
- Provide quality and compliance oversight for the qualiﬁcation, and validation, of manufacturing, laboratory and testing processes. Including, review and approval of qualiﬁcation and validation protocols, summary reports and associated data for conformance to regulations, SOPs, speciﬁcations, and other applicable acceptance criteria
- Provide quality and compliance oversight for the commissioning and qualification of site facility spaces and utilities. Including review and approval of Change Controls, Project Validation Master Plans, Commissioning Test Plans, Qualification protocols, SOP’s and Summary Reports.
- Provide quality and compliance oversight for scheduled and periodic maintenance activities within the manufacturing and testing facility. Including, review and approval of documentation supporting Plant and Laboratory Maintenance, whose function is to perform planned (Preventative maintenance) and unplanned (work orders and change controls) maintenance for equipment and instruments
- Review and approve Risk Assessments, Change Controls, SOPs, FMEA, Periodic Qualiﬁcations, Project Plans, Master Plans
- Ability to manage multiple and complex projects, provide status reports and coordinating with other departments and/or outside contractors/vendors to complete validation tasks
- Judgment and problem-solving – able to deﬁne decision criteria and determine the most appropriate course of action.
- Planning and organizational skills – able to establish objectives and schedule tasks/resources efﬁciently. Communication skills – strong written communication skills to provide concise and clear documentation Partner with a team setting to support continuous improvement initiatives. Support technical and quality investigations to resolve issues
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
- Require minimal direction to complete tasks, knows how to obtain resources and information from established internal contacts; consult with manager for decisions outside established processes
- Bachelor of Science degree or higher education in Engineering or Science
- 5+ years in a highly regulated environment such as biotechnology, pharmaceutical or related ﬁelds, including a signiﬁcant exposure to regulatory requirements
- 10 + years in a highly regulated environment such as biotechnology, pharmaceutical or related ﬁelds, including a signiﬁcant exposure to regulatory requirements (Senior level)
- Experience in technical writing for cGMP documents
- Prior experience in developing equipment validation, process validation, packaging qualiﬁcation and cleaning validation
- Experience in writing & reviewing SOPs and protocols for accuracy and compliance
- Ability to work closely with multiple disciplines, including Manufacturing, Maintenance, Facilities, Quality Control, Laboratory and Quality Assurance to execute validation protocols
- Ability to apply comprehensive knowledge of pharmaceutical cGMPs and quality system controls, procedures and records to ensure ongoing quality compliance
- Ability to perform all requirements independently with limited managerial oversight
- Excellent organizational abilities to meet accelerated timelines, manage multiple shifting priorities and maximize efﬁciencies in a dynamic customer-focused environment
- Superior attention to detail to ensure accuracy of work product
- Superior critical-thinking and problem-solving skills; ability to recognize and resolve discrepancies and issues
- Advanced computer skills to increase department’s productivity, as well as broadening technical and scientiﬁc knowledge