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Senior Quality Assurance Associate Operations Lead
2 months ago
About Baxter
Baxter is a global pharmaceutical company dedicated to saving and sustaining lives. Our mission is to improve outcomes for millions of patients worldwide.
Job Summary
We are seeking a Senior QA Associate Operations Lead to join our team in Elstree, UK. As a key member of our operations team, you will play a crucial role in ensuring the quality and compliance of our products.
Main Responsibilities
- Support the batch review process and release of raw materials and components for processing
- Release finished product to market and support investigations into non-conformances, CAPAs, and complaints
- Compile release data for finished products, including product bioburden, sterilization, and test results
- Collate, review, and complete batch documentation to support release
- Ensure closure of deviations prior to release to ensure timely release of product
- Support document control activities and filing/archiving of completed DHRs and batch/order documentation
- Coordinate and assist with the development of SOPs and specifications
- Support quality investigations and liaison with Baxter, Elstree staff, and sub-contractors as necessary
- Adhere to Baxter, Elstree relevant policies and procedures at all times
- Support internal audits, supplier audits, and regulatory inspections as required
- Manage the statistical process control (SPC) process for review of manufacturing and quality data
- Perform administrative tasks for supplier quality QMS, creation of part numbers, and update of Bill of Materials
Requirements
- Degree or equivalent qualification in a scientific, technical, or engineering subject (desired but not essential)
- Experience working to ISO13485, FDA (21 CFR) part 820, or GMP (Orange Guide) compliant systems
- Experience in reviewing and releasing finished product to market or for final disposition
- Quality investigational tool training
- Familiarity with NCR/CAPA, document control processes within a regulated QMS, and auditing
- QA experience in cleanroom environments – sterile/aseptic manufacturing
- Excellent communication skills
What We Offer
Baxter offers a dynamic and collaborative work environment, with opportunities for professional growth and development. We are committed to saving and sustaining lives, and we are looking for individuals who share our passion and values.