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Senior Quality Assurance Associate Operations Lead

4 weeks ago

St Albans, Hertfordshire, United Kingdom Baxter Full time

Transforming Healthcare through Quality Excellence

Baxter, a global leader in pharmaceuticals, seeks a highly skilled Senior QA Associate Operations Lead to join our Elstree, UK team. As a key member of our world-class manufacturing operations, you will play a crucial role in ensuring the highest quality standards are met.

Main Responsibilities:

  • Support the batch review process to ensure flawless quality
  • Release raw materials and components for processing, and finished product 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 product release
  • Document control: support document control activities, filing, and archiving of completed DHRs and batch/order documentation
  • Deviation management: support quality investigations to release finished product using quality investigational tools
  • Liaise with Baxter staff and subcontractors to carry out investigations
  • Quality Assurance/Control: adhere to Baxter policies and procedures at all times, and notify any deviations/exceptions from process
  • Support QMS through internal audit participation, supplier audits, and regulatory inspections
  • Support change control projects, new product development, sterilization validations, endotoxin testing, environmental monitoring, and purified water testing
  • Manage statistical process control (SPC) 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 dedicated to saving and sustaining lives. Our products and therapies are found in almost every hospital worldwide, in clinics, and in the home. We have pioneered significant medical innovations that transform healthcare for over 85 years.

What We Offer:

Baxter offers a dynamic and collaborative work environment, where you will have the opportunity to make a positive impact on people's lives. As a Senior QA Associate Operations Lead, you will be part of a close-knit team, working together to achieve our mission.