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Senior Quality Assurance Associate Operations Lead

2 months ago

St Albans, Hertfordshire, United Kingdom Baxter Full time

Transforming Healthcare through Quality Excellence

Baxter, a global leader in pharmaceuticals, is seeking a highly skilled 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 life-saving products.

Main Responsibilities:

  • Support the batch review process to ensure flawless quality
  • 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 regulations
  • 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
  • Deviation management: support quality investigations to support release of finished product
  • Liaise with Baxter staff and subcontractors as appropriate to carry out investigations
  • Quality Assurance/Control: adhere to Baxter policies and procedures at all times and notify any deviations/exceptions from process
  • Support internal audits, supplier audits, and regulatory inspections as required
  • Support change control projects, new product development projects, sterilization validations, endotoxin testing, environmental monitoring, and purified water testing
  • Manage 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

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

About Baxter:

Baxter is a global pharmaceutical company that manufactures life-saving products. Our Elstree site is a close-knit team of 36 employees, with some employees having been with the company for over 20 years. We are dedicated to saving and sustaining lives, and your work will have a direct impact on millions of patients globally.

What's Next?

We are excited to welcome a talented and motivated individual to our team. If you are passionate about quality and compliance, and have a strong background in GMP and QA, we encourage you to apply for this exciting opportunity.