Our client, a leader in the pharmaceutical industry, is seeking a QA Senior Associate to join their team.
**This job is 5 days onsite in Bedford, MA**
**W2 Only**
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.
Responsibilities:
Qualifications:
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