Confidential
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The information below covers the role requirements, expected candidate experience, and accompanying qualifications. Base pay range $55.00/hr - $65.00/hr Direct message the job poster from Confidential Job Title QA Sr. Specialist Shift Schedule
1st shift (Mon to Fri) 09:00 AM to 05:00 PM 2nd shift (Wed to Sat) 12:30 PM to 11:00 PM 3rd shift (Sun to Wed) 12:30 PM to 11:00 PM Overview The Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Sr. Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Manager GMP Quality - Cell & Gene. Ideal candidate will have strong experience in deviation, QC data review, quality events, QA operations, documentation and batch review. Sr Specialists will be executing disposition and Quality on the Floor (including walkthroughs) activities per the Quality Ops task list. KEY RESPONSIBILITIES
As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy operations in the following key areas/activities: support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups. Lead QA efforts to establish new programs to support Drug Product facility including start-up of assembly, packaging and label operations Responsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition. Responsible for review and approval of COAs, and product release Provide production floor support and guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provide direction for product disposition decisions including shipment. Review and approval of manufacturing documents. Develop and deliver technical training programs Support drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified. Provide experienced technical advice for fill finish related program decisions Provide project support involving technical transfers, engineering projects and similar activities Participate in compliance walkthroughs and help drive the closure of any observations Identify risks and communicate gaps for GMP process/systems Identify risks and communicate any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc. Participate in continuous improvements of department processes. Participate in inspection readiness and support activities Participate in process improvement initiatives (as necessary). Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issues in a timely manner Experience on product complaints investigations and recalls REQUIRED EDUCATION AND EXPERIENCE
Demonstrated success by independently leading cross-functional teams Experience providing QA support and oversight of GMP manufacturing operation including batch release Experience with ATMP drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting: o Cell and gene therapy cGMPs and associated CMC regulatory considerations o Aseptic processing Experience successfully leading event investigations, Root Cause Analysis and CAPA Experience with network-based applications such as Oracle, TrackWise
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The information below covers the role requirements, expected candidate experience, and accompanying qualifications. Base pay range $55.00/hr - $65.00/hr Direct message the job poster from Confidential Job Title QA Sr. Specialist Shift Schedule
1st shift (Mon to Fri) 09:00 AM to 05:00 PM 2nd shift (Wed to Sat) 12:30 PM to 11:00 PM 3rd shift (Sun to Wed) 12:30 PM to 11:00 PM Overview The Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Sr. Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Manager GMP Quality - Cell & Gene. Ideal candidate will have strong experience in deviation, QC data review, quality events, QA operations, documentation and batch review. Sr Specialists will be executing disposition and Quality on the Floor (including walkthroughs) activities per the Quality Ops task list. KEY RESPONSIBILITIES
As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy operations in the following key areas/activities: support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups. Lead QA efforts to establish new programs to support Drug Product facility including start-up of assembly, packaging and label operations Responsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition. Responsible for review and approval of COAs, and product release Provide production floor support and guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provide direction for product disposition decisions including shipment. Review and approval of manufacturing documents. Develop and deliver technical training programs Support drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified. Provide experienced technical advice for fill finish related program decisions Provide project support involving technical transfers, engineering projects and similar activities Participate in compliance walkthroughs and help drive the closure of any observations Identify risks and communicate gaps for GMP process/systems Identify risks and communicate any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc. Participate in continuous improvements of department processes. Participate in inspection readiness and support activities Participate in process improvement initiatives (as necessary). Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issues in a timely manner Experience on product complaints investigations and recalls REQUIRED EDUCATION AND EXPERIENCE
Demonstrated success by independently leading cross-functional teams Experience providing QA support and oversight of GMP manufacturing operation including batch release Experience with ATMP drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting: o Cell and gene therapy cGMPs and associated CMC regulatory considerations o Aseptic processing Experience successfully leading event investigations, Root Cause Analysis and CAPA Experience with network-based applications such as Oracle, TrackWise
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