QA Associate, Baxter

QA Associate

Baxter

Location:

United Kingdom, St Albans

Category:

Quality Control

Contract Type:

Employment contract

Salary:

Not provided

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Job Description:

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility:

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
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
Inspection of goods and material dispositioning
Co-ordination of investigations into non-conforming product
Support of calibration, maintenance and revalidation activities for equipment and facilities
Monitoring of schedule and tracking execution of activities
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

Requirements:

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

Nice to have:

Internal Auditing experience
Familiarity with NCR/CAPA, complaint and document control processes within a regulated Quality Management System

What we offer:

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
25-days annual leave + bank holidays
Shutdown between Christmas and new year

Additional Information:

Job Posted:

March 20, 2025

Expiration:

June 03, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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