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The Quality Assurance Lead III reports to the Associate Director, Allston Integrated Remediation Quality Systems Leader (QSL) and has responsibility for the support of the Quality function to the needs of the AIR Program. The QA Lead III performs all necessary Quality and cGMP compliance activities assigned to the team (FEU, OR, or PV) per the needs of the schedule. The QA Lead III performs quality oversight activities for the delivery of Consent Decree Workplan numbered steps 13.24, 13.25, 13.26, 13.27, 13.28, 17.11, 11.08 and 11.15. The QA Lead III executes the program activities following approved Allston Site and Genzyme Corporate Quality standard operating procedures and guidelines.
Skills: Specific AIR Program responsibilities as directed by the QSL include:
Performance of Quality and cGMP compliance activities in accordance with the program schedule; Coordination with Site Quality resources to support the needs of the AIR program, such as: Engineering Document Control, Change Control, etc.; Performance of Consent Decree Numbered Step oversight activities that are executed consistently, accurately and on time; Performance of quality oversight of deliverables related to numbered steps in the Consent Decree Workplan (CDW) in a timely manner; Identification and reporting of verification issues; Effective communications within their Quality Team; Identification and reporting of quality related risks; Collaboration with the QSL, to help achieve the overall program objectives; Alignment to the Genzyme standards by developing compliant, simple, sustainable, non-redundant systems that includes the appropriate role of Quality; Leverage and alignment of interfaces between all systems through communication across teams; Oversight, performance and coordination of the document control process and compliance oversight of project documents records, local change request process; Quality oversight of new facility and utility design, architecture and construction, including associated AIR Project documentation; Review and approval of AIR technical reports; GMP drawing sets; decommissioning protocols or plans, engineering studies; design specifications; project change forms; change controls; return to service notifications, corrective maintenance work orders, and action notices; as they pertain to the AIR Program; Review and approval of AIR equipment and facility user requirement specifications; system impact and critical aspect analysis; design qualification protocols and summary reports; IQ, OQ, IOQ checklists; performance qualification protocols and reports; CCR validation assessment concurrence; computer system validation plans and testing protocols, summaries, reports, trace matrices.
Participation in program reviews and risk assessments
Education: Bachelor of Science in Science or Technical field and 7 years of CGMP experience
3 years of experience in Quality Assurance and Engineering related to Quality support for ongoing manufacturing operations
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