Senior QA Associate Operations Lead

at  Baxter

THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Are you ready to make a difference in the world? Join Baxter Healthcare Corporation as a Senior QA Associate Operations lead in Elstree, UK. At Baxter, we are dedicated to saving and sustaining lives, and your work will have a direct impact on millions of patients globally.
Baxter is a global pharmaceutical company who manufacture many life saving products but here in Elstree we specifically manufacture bone hemostats and synthetic bone graft material for Surgeons to use in operating theatres. The site has 36 employees so although a large company, we remain a close-knit team, with some of our employees having been here over 20 years.
As a Senior QA Associate, you will play a crucial role in our world-class manufacturing operations. Your attention to detail and proven ability to ensure flawless quality will be essential to our success. We are seeking ambitious individuals who thrive in a collaborative environment and have a passion for delivering exceptional results.

EXPERIENCE REQUIRED

• 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

• Support of the batch review process
• Release of raw materials and components for processing
• Release of finished product to market and support for investigations into non-conformances, CAPAs and complaints to maintain compliance with ISO13485 and FDA (21 CFR) part 820 and the requirements of MDSAP.
• Product release: 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 to aid rapid retrieval. Co-ordinate and assist with the development of SOPs and specifications, liasing with appropriate personnel to progress updates and approvals.
• Deviation management: Support for and co-ordination of quality investigations to support release of finished product through use of quality investigational tools.
• Liason 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.
• Be contact for Operations team for day to day issues during manufacture