Quality Assurance Associate

Zvh; Elstree; On-site; GBP 28,000 - 38,000; Full time

Benefits offered by this job

25 days annual leave

Pension 8%

Westfield healthcare

Employee assistance programme

Local bonus

Professional development opportunities

Work-life balance

Inclusive workforce

Job summary

Baxter Elstree site is recruiting a QA Associate to support quality activities in a GMP-regulated environment. The role involves sampling, testing, release data compilation and coordination with contract labs.

The position requires a Bachelor's in a scientific field and 2+ years’ experience in GMP/medical devices; familiarity with ISO 13485 and NCR/CAPA processes is preferred. Cleanroom PPE is required, and there are strong development opportunities.

Qualifications

• QA, cGMP and Quality Systems in an Operational Quality environment.
• Knowledge of clean room control requirements.
• Familiarity with NCR/CAPA, complaint and document control processes within a regulated QMS.
• Working in a fast paced, rapidly changing environment, supporting new product introduction.
• Excellent investigational, analytical and problem solving skills.

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 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.

Skills

QA & GMP

Clean room

NCR/CAPA

Document control

Analytical skills

Communication

Education

Bachelor's degree in scientific or technological subject

Job description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Summary

Summary 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. 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 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.

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 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.

Experience / Qualifications

• 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
• Internal Auditing experience.
• 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.

What we offer

• 25 days annual leave plus bank holidays (Increasing with service)
• Up to 8% pension contribution
• Westfield healthcare Employee discount scheme
• Employee assistance programme
• Competitive salary + local bonus*
• Professional development opportunities
• High importance placed on work life balance
• Commitment to growing and developing an inclusive and diverse workforce

Equal Employment Opportunity

Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.