Senior Quality Assurance Associate Operations Lead
2 days ago
About Baxter
Baxter is a global leader in the development and manufacture of life-saving medical products. Our mission is to save and sustain lives, and we are committed to delivering high-quality products and services to our customers.
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 critical 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 of finished product to market and support for investigations into non-conformances, CAPAs and complaints
- Compilation of release data for finished products, including product bioburden, sterilisation and test results
- Collations, review and completion of batch documentation to support release
- Ensure closure of deviations prior to release to ensure timely release of product
- Documentation control: Support of document control activities, responsibility for filing/archiving completed DHRs and batch/order documentation post release
- Deviation management: Support for and co-ordination of quality investigations to support release of finished product
- Liaison with Baxter, Elstree staff and sub-contractors as appropriate to carry out investigations
- Quality Assurance/Control: Adherence to Baxter, Elstree relevant policies and procedures at all times and notification of any deviations/exceptions from process
- Support for all aspects of the QMS through participation in internal audit as trained and approved internal auditors, participation in supplier audits as necessary
- Support for investigations into incidents such as complaints, and any subsequent field correct actions/recalls
- Support for regulatory inspections as required
- Support for change control projects, new product development projects, sterilisation validations, endotoxin testing, environmental monitoring and purified water testing
- Manage the statistical process control (SPC) process for review of manufacturing and quality data
- Administrative tasks for supplier quality QMS, creation of part numbers and update of Bill of Materials
- Participate in cross-functional project teams and attend meetings as a representative of Quality, as designated by the Head of Quality
- Practice continuous improvement during daily activities and establish good working relationships with other teams
Requirements
- Degree or equivalent qualification in a scientific, technical or engineering subject desired but not essential if you can demonstrate 2+ years experience in a GMP environment
- 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
- Field of expertise. QA, cGMP and Quality Systems in an Operational Quality environment
- Knowledge of clean room control requirements
- Excellent communication skills
What We Offer
Baxter offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment, and we welcome applications from candidates from all backgrounds.
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