Quality Assurance
2 weeks ago
At Baxter, we are deeply connected by our mission. 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.
Our Elstree site is currently recruiting for a QA Associate. Baxter is a global pharmaceutical company who manufacture 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. This role is Monday-Friday 7:30 – 4pm, we offer an attractive salary along with 25-days annual leave + bank holidays. 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). Testing and inspection of product, as required by SOP and Finished Product Specification.
Co-ordination of product testing with external contract laboratories.
Compilation of release data for finished products.
Co-ordination of product bioburden data.
Inspection of sterilized finished product received back from subcontractors.
Goods Inwards Quality 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 incidences 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.
QA, cGMP and Quality Systems in an Operational Quality environment. Knowledge of clean room control requirements.
Bachelor’s degree in scientific or technological subject
A minimum of 2 plus years’ experience required in the areas of GMP regulations that pertain to the medical devices / pharma / biologics - Quality, Manufacturing, Engineering or related field which where possible 1-2 years of supervisory experience is preferable
Familiarity with NCR/CAPA, complaint and document control processes within a regulated Quality Management System.
Ability to review and monitor data, and identify trends.
Our Baxter Talent Acquisition team will review your application (please ensure your up-to-date CV is attached) and if deemed suitable you will be sent a hire Vue assessment to complete. This acts as a first stage interview and is a mixture of written and video responses. We will review this along with the hiring manager and if successful you will be invited on site in Elstree for an interview with the Quality Team.
#Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .
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