Senior Quality Assurance Associate - Microbiologist
Req #: 18000241_en
Location: Hertfordshire, ENG UK
Job Category: Quality
Date Posted: 1/26/2018 11:12:01 AM
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
The role of the Senior Quality Assurance Microbiologist is to provide an effective and compliant release service for Baxter, Elstree.
Support of the batch review process, release of raw materials and components for processing, release of finished product to market.
Provide support for investigations into non-conformances, CAPAs and complaints to maintain compliance with ISO13485 and FDA (21 CFR) part 820 requirements, through the use of quality investigational tools.
The microbiology role is focused on product bioburden testing, endotoxin testing and sterilisation along with co-ordination of environmental monitoring activities and providing microbiological expertise to site.
Compilation of release data for finished products, including product bioburden, sterilisation, endotoxin and test results. Ensure closure of deviations prior to release to ensure timely release of product. Maintain trend analysis and manage improvements with Operations.
Co-ordinate monitoring activities and maintenance of trend analysis. Manage improvements with Operations.
Manage sterility assurance activities with Operations, Quality and the sterilisation contractor. Prepare protocols and reports, co-ordinate samples and manages the dose audit testing schedule. Maintain trend analysis and manage improvements with Operations.
Maintain the Microbiological Contamination Control Plan in line with process improvements and manage those improvement opportunities highlighted with Operations.
Support of document control activities including responsibility for filing/archiving completed DHRs and batch/order documentation post release to aid rapid retrieval. Co-ordinate and assist with the development of Standard Operations Procedures
Support for and co-ordination of quality investigations to support release of finished product through use of quality investigational tools.
Adherence to Baxter, Elstree relevant policies and procedures at all times and notification of any deviations/exceptions from process.
Support for change control projects, new product development projects, sterilisation validations, endotoxin testing, environmental monitoring and purified water testing.
Skills and Experience
- Substantial Quality Control experience in a Microbiology laboratory – understanding of bioburden testing and endotoxin testing
- Knowledge of sterilization operations and experience of sterilization validation desirable
- Experience working to ISO13485, FDA (21 CFR) part 820 or GMP (Orange Guide) compliant systems.
- Quality investigational tool training. Familiarity with NCR/CAPA, document control processes within a regulated QMS and auditing.
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, colour, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.