As a Senior Specialist, Quality Assurance (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 Senior Associate, Quality Assurance (Warehouse Operation) 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.
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.
Travel may be required up to 5%. Ability to travel to other Boston-area locations for larger team meetings.