SENIOR QA SPECIALIST

Our client, a leading pharmaceutical company focused on discovering, developing, manufacturing, and commercializing therapeutic treatments is currently seeking a Senior QA Specialist for a 1-year contract (potential to extend). This person will be responsible for coordinating GMP activities in support of clinical and commercial drug product disposition. This is a second shift position, either Wed-Sat 12:30 -11pm, or Sun-Wed 12:30-11pm.

QUALIFICATIONS:

• Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 3-5 years of relevant work experience, or relevant comparable background.
• 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
• Cell and gene therapy cGMP’s and associated CMC regulatory considerations
• Aseptic processing
• Experience successfully leading event investigations, Root Cause Analysis and CAPA
• Experience with network-based applications such as Oracle, TrackWise
• Experience on product complaints investigations and recalls
• Ideal candidate will have strong experience in deviation, QC data review, quality events, QA operations, documentation and batch review.
• Strong leadership skills with the ability to thrive in a high throughput environment
• Expert knowledge of GMP requirements governing oral drug products manufacturing practices
• Proven experience supporting GMP manufacturing either via experience in manufacturing and /or experience providing QA operational support of GMP Manufacturing

• Providing quality oversight and support to 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 company, 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).