Job Description

Job Title: QA Sr. Specialist

Location: Boston, MA

Shifts available:-

(1st-Mon to Friday 09 AM to 05 PM)

(2nd-Wed to Sat 12.30 to 11 PM)

(3rd-Sun to Wed 12.30 to 11 PM)

• Relevant commercial experience
• Pharma/biotech background
• Batch record or QC data review
• Clean room support
• Must have QA experience
• First 2 weeks will be Mon-Fri for training then shift will change

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 provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.

· Review and approval of manufacturing documents.

· Develop and deliver technical training programs

· Supports 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.

· Provides experienced technical advice for fill finish related program decisions

· Provides project support involving technical transfers, engineering projects and similar activities

· Participate in compliance walkthroughs and help drive the closure of any observations

· Responsible for identifying risks and communicating gaps for GMP process/systems

· Responsible for identifying risks and communicating 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 issue 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 cGMP’s 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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