Senior Specialist, Quality Assurance Operations

Position Summary:

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As Quality Assurance Drug Substance (DS) Specialist, you will be responsible for Quality Assurance activities at the new gene therapy manufacturing facility located in Bedford, MA. You will provide direct QA oversight and support for the core Drug Substance Manufacturing activities. Activities will include Production Batch Record review, deviation management, QA Manufacturing walkthroughs, logbook review and room/equipment tag-out for manufacturing use. The site is a multi-product facility which will be used for drug substance manufacturing, and aseptic filling of drug product. QA activities are primarily focused on the drug substance manufacturing areas but could also support Drug Product when required. Your role will partner with Manufacturing, Engineering, Validation, QC, Quality Systems, and MSAT functions to provide QA approval for various operating procedures, DS manufacturing processes, and batch records required for on-going manufacturing at the facility. You will report to the Associate Director, Quality Assurance at Ultragenyx Gene Therapy.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

• Review/Approval of Master Batch Records and review/approval of executed DS Production Batch Records
• Perform QA review/approval of DS area shutdowns/restarts after planned or unplanned maintenance/EM events etc.
• Perform routine area walkthroughs, logbook reviews, inspection readiness assessments.
• Responsible for writing, reviewing and/or approving documents such as SOPs, work instructions, policies, and standards to enable the execution of GMP manufacturing.
• Work with various functions to resolve deviations and assess potential product and compliance impact. Escalate significant events to Quality Management and drive timely completion of effective investigations.
• Drive or support continuous improvement activities to support elimination of waste to enable an effective and efficient manufacturing site/process. Champion process improvement where applicable.

Requirements:

• Minimum B.S. degree in scientific field such as microbiology, chemistry or biochemistry. 5+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries with Manufacturing and Quality roles.
• Direct experience working at a biologic or advanced therapy medicinal product (ATMP) manufacturing site. Knowledge and experience with drug substance and aseptic practices.
• Knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell, or gene therapy products.
• Demonstrated ability to communicate technical information or complex situations to site management and/or health authority inspectors in a concise and clear manner.

Physical Demands/Work Environment/Safety Considerations:

• Stand for extended periods of time with periodic stooping / bending / kneeling.
• Able to lift, push, pull up to 50lbs.
• Climb ladders and stairs of various heights.
• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
• Certain tasks may require the use of a respirator; medical clearance will be required in advance.
• Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment.
• Working in temperature-controlled environments (cold rooms).

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