Manager/Senior Specialist, Quality Assurance (Warehouse Operations)
16 Crosby Drive Bedford, MA 01730 US
As a Manager/Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes for a biotech 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. During the qualification phase, this role will provide critical quality oversight of the incoming material process to ensure compliant receipt, inspection and release of materials used in cGMP manufacturing operations. As the site becomes operational, 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, Validation, 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. This role will be key contributor of the Material Review Board (MRB) and will support quality decisions related to material movement, supplier management and multi-product controls at the site. As new products are introduced, the Manager/Senior Associate, Quality Assurance (Warehouse Operation) will work cross-functionally to onboard GMP materials through participation in risk assessments, Material Review Board, generation of specifications, master data review and supplier qualification activities.
- Collaborate in the design and implementation of effective Quality Assurance systems for material inspection, disposition, and movement at new Gene Therapy Manufacturing Facility.
- Support supplier quality management and multi-product material controls at the site.
- Employ Quality Risk Management (QRM) to evaluate new challenges impacting the Warehouse and/or Supply Chain. Perform formal risk assessments as applicable.
- 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.
- Responsible for reviewing, and approving ERP processes (and metadata) to ensure seamless integration and accuracy with manufacturing operations and batch disposition.
- Conduct Quality Assurance (QA) assessments required for the onboarding, use/release, management, and qualification of GMP materials.
- Execute QA review and approval of master data in the ERP system. Verify chain of custody and complete final release of GMP raw materials.
- Perform QA assessment of non-conforming materials and monitor Quality Metrics associated with the material and supplier.
- Identify and implement continuous improvement activities to eliminate waste and increase the efficiency and effectiveness of Quality oversight.
- Minimum B.S. degree; preferably in scientific or engineering field.
- 5+ years of experience in GMP regulated industry (preferably biopharmaceutical, biotechnology cell or gene therapy industries) with roles in Supply Chain, Manufacturing or Quality.Quality experience preferred.
- Experience working at a biologic or advanced therapy pharmaceutical manufacturing site.
- Strong 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 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.
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