Opportunity to work for biopharma company focused on developing rare disease treatments.
Job Detail
Job Description
As a Specialist, Quality Assurance (Material and Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging / labeling operations. This role will provide critical quality support to process to ensure compliant receipt, inspection and release of materials used in cGMP manufacturing operations. You will be essential to Quality floor support of the warehouse and cryogenic facilities. This includes leading the effective resolution of deviations and nonconformances associated with materials, suppliers, and storage.
Your role will partner with Supply Chain / Warehouse, Manufacturing, Engineering, IT (ERP) and Quality Control functions to execute and continuously improve operating procedures that interface with the ERP system such as label inspection, container/closure inspection, retain management and disposition of
starting and raw materials. As new products are introduced, the QA Specialist, will support the onboarding of GMP materials through participation in risk assessments, Material Review Board, generation of specifications, master data review and supplier qualification activities.
Core Responsibilities.
• Execute Quality Assurance procedures for material inspection and disposition, at new Gene
Therapy Manufacturing Facility.
• Support supplier quality management including change notifications and corrective action
requests.
• Assist with the onboarding of new GMP materials and suppliers.
• Conduct Quality assessment of non-conforming materials and evaluate trends.
• Inspect labels, starting materials and fill/finish components before use in manufacturing.
• Responsible for writing, revising, reviewing and/or approving documents associated with GMP
materials such as SOPs, work instructions, and protocols.
• Work cross-functionally to investigate and resolve deviations.
• Execute QA review and approval of master data in the ERP system. Verify chain of custody and
complete final release of GMP raw materials.
• Identify and implement continuous improvement activities to eliminate waste and increase the
efficiency and effectiveness of Quality oversight.
Requirements
• Minimum B.S. degree; preferably in scientific or engineering field.
• 3+ years of experience in GMP regulated industry with roles in Supply Chain, Manufacturing or
Quality. Quality experience preferred.
• Experience working at a pharmaceutical manufacturing site.
• Strong knowledge of 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 supervisor or
area management in a concise and clear manner.
Management Skills
• Problem Solving & Decision Making: Spot and solve problems on a regular basis through
outstanding attention to detail, innovative thinking, and the ability to remain calm under pressure.
Seek out knowledge and understanding to confidently resolve issues independently.
• Partner & Collaborate Effectively: Listen to and value others’ thoughts and ideas. Demonstrate
effective partnership both within and outside your team. Achieve results with and through others.
• Support Learning & Growth: Demonstrate self-awareness, humility, and curiosity in service of self?development. Provide regular coaching and feedback that will inspire growth and improvement in
others.
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