QA Associate – GMP/Pharma Cleanroom

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

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.