Senior QA Specialist II, QA External Biologics, Disposition – Shire – Lexington, MA, USA
Works in the External Biological QA team of Shire United States (US) Quality Assurance. This unit includes oversight of external drug product manufacturing at contract manufacturers, laboratory operations, internal warehouse operations, packing and labeling operations, batch release and logistics performed on behalf of Shire. This unit also provides QA support for Quality Control (drug substance, drug product testing and stability).
This individual will support all disposition activities related to external commercially manufactured medical device, drug substance, drug product and finished drug. The individual is responsible for achieving the functional area goals and objectives as they relate to individual and Shire goals. Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, DNA leadership capabilities and BRAVE values. The position require approximately up to 15% travel.
This position is responsible for review and release of all records associated with external manufacturing including plasma, drug substance, fill/finish bulk product and finished drug product (protein based, human blood products, …). Supports cold chain and evaluation of cold chain as related to movement of drug substance, drug product, and finished drug product to the end user. The individual may be responsible for, but is not limited to:
• Prepare and execute plasma, biologic drug product and finished drug product (protein and human blood types, at a minimum) batch disposition in accordance with priorities and regulatory commitments
• Review of all quality systems: SOPs, specifications, executed batch records, deviations, CAPAs and change controls as related to disposition and cold chain
• Review and approval of product specification and Certificate of Analysis
• Prepare drug product annual review report sections
• Understanding of GMP’s; primary decision maker on issues of major complexity and knows to raise issues of advanced complexity
• Responsible for continuous improvement on an ongoing basis to mitigate current gaps
Education & Experience Requirements:
• Bachelor’s degree in chemistry, biology or a related discipline.
• 8 years Quality Assurance experience supporting the manufacture and release of commercial drugs, biologics or devices manufactured at CMOs
• Working knowledge or batch record review
• Working knowledge of human blood and blood products requirements
• Experience with authoring Drug Product Annual Product Quality Reports
• Good understanding of quality systems and cGMPs
• TrackWise, LIMS and SAP experience
• Interpersonal skills and professional skills to interact with customers
• Must be flexible
• Must be able to prioritize and multitask in a stressful environment
• Fluency in English is required.
Key Skills, Abilities, and Competencies:
Qualified candidates will have:
• Critical thinking/ evaluation of process problems
• Data trending and evaluation
• Ability to multi-task in environment with changing priorities
• Strong work ethic
• Proactively addressing compliance issues and assuming responsibility for compliance deficiencies
• Actively leading “Lessons Learned” activities
• Ability to develop gap analysis and action plans
Complexity and Problem Solving
• Evaluation of batches to ensure there is no impact to safety, identity, strength, quality, or purity
• Evaluation of changes to regulatory filings and/or validated systems.
• Evaluation of manufacturing or operational issues for impact and communication to management.
• The individual will be responsible for prioritization of workload and communicating effectively with the Manager. Responsible for implementing site-specific QA approaches based on existing guidance and quality standards, sound principles, international industry/regulatory standards, and robust scientific basis. This individual will bring any concerns to the Manager immediately.
• Impact of schedule changes to commercial supply.
The person in this role must have the ability to analyze operational and compliance process gaps and bottlenecks, and implement effective corrective actions to increase efficiency and/or improve compliance as it relates to biologics and blood derived products.
Internal and External Contacts
Internal: This role provides QA responsibilities for disposition of product from Shire biological external manufacturing sites. The role is accountable directly to the Director of Biological External Operations.
• Supply Chain/Global Logistics
• Contract Manufacturing
• Program Management
• Regulatory Affairs
• Quality Control
• International External Quality
External: Contract Manufacturing Organizations, Consultants/Contractors, Regulatory Agencies
Other Job Requirements:
Periodic domestic travel is required for business meetings with regional Quality team, corporate peers/collaborators, vendors/contractors, and to stay current with professional development opportunities.