Senior Quality Assurance Associate Operations Lead

2 days ago

St Albans, Hertfordshire, United Kingdom Baxter Full time

About Baxter

Baxter is a global pharmaceutical company dedicated to saving and sustaining lives. Our mission is to improve healthcare outcomes for millions of patients worldwide.

Job Summary

We are seeking a Senior Quality Assurance 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 manufacturing operations.

Main Responsibilities

  • Support the batch review process to ensure compliance with regulatory requirements.
  • Release raw materials and components for processing, and finished products to market.
  • Investigate non-conformances, CAPAs, and complaints to maintain compliance with ISO13485 and FDA (21 CFR) part 820.
  • 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.
  • Document control: Support document control activities, responsibility for filing/archiving completed DHRs and batch/order documentation post release.
  • Deviation management: Support for and coordination 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: Adhere to Baxter, Elstree relevant policies and procedures at all times and notify 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 corrective actions/recalls.
  • Support for regulatory inspections as required.
  • Support for change control projects, new product development projects, sterilization 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.
  • Be contact for Operations team for day-to-day issues during manufacture.

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.

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