QA Associate

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. Our Elstree site is currently recruiting for a QA Associate. Baxter is a global pharmaceutical company that manufactures many lifesaving products, but here in Elstree, we specifically manufacture bone haemostats, which is 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. This role is Monday-Friday 7:30 – 4pm, and we offer an attractive salary along with 25 days annual leave + bank holidays. We also have a shutdown between Christmas and New Year. As part of the role, the manufacturing area is a grade IS07 & IS08 cleanroom which requires full PPE (gown, goggles, hair net, and full cleanroom suit). Please only apply for this role if you believe you would feel comfortable in this PPE. This role is very hands-on, and you will spend time in the cleanroom and labs as part of your role. Essential Duties and Responsibilities Sampling of intermediate products within the manufacturing process. Testing and inspection of product, as required by SOP and Finished Product Specification. Co-ordination of product testing with external contract laboratories. Maintain compliance with ISO 13485 and FDA (21 CFR) part 820 and the requirements of MDSAP. Product Release: Compilation of release data for finished products. Co-ordination of product bioburden data. Collation and completion of documentation to support release. Inspection of sterilized finished product received back from subcontractors. Support to releasers for disposition/release of finished product. Goods Inwards Quality Control: Inspection of goods and material dispositioning. Co-ordination of investigations into non-conforming product. Calibration/Maintenance Control: Support of calibration, maintenance, and revalidation activities for equipment and facilities. Monitoring of schedule and tracking execution of activities. Quality Assurance/Control: Adherence to Baxter Elstree’s 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 auditors and support for incidents such as complaints, and any subsequent field corrective actions/recalls. Support for and co-ordination of Quality Investigations i.e. NCR/CAPA/Complaint handling, and logging/issuing of QMS numbers. Experience / Qualifications QA, cGMP and Quality Systems in an Operational Quality environment. Knowledge of clean room control requirements is beneficial. Bachelor’s degree in scientific or technological subject or equivalent. A minimum of 1 year's experience required in the areas of GMP regulations that pertain to the medical devices/pharma/biologics - Quality, Manufacturing, Engineering or related field. Internal Auditing experience would be an advantage. Familiarity with NCR/CAPA, complaint and document control processes within a regulated Quality Management System. Working in a fast-paced, rapidly changing environment, supporting new product introduction. Excellent investigational, analytical and problem-solving skills. Ability to review and monitor data, and identify trends. Highly proficient communicator, both verbal and written.

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