Quality Assurance Auditor — Preclinical Lab Compliance

Transpharmation Ltd.; Stone Cross; On-site; GBP 32,000 - 52,000; Full time

Benefits offered by this job

Competitive wages

Benefits package

Job summary

Transpharmation Ltd. is seeking a Quality Assurance Officer to provide independent assurance of compliance with regulatory requirements and company standards. This role involves conducting audits, reviewing documentation, and QC of study data for studies.

You will support QA activities across projects, prepare QA statements for final reports, maintain training records, and liaise with regulatory bodies as needed.

Qualifications

• Bachelor's degree in Life Sciences (e.g., Biology, Chemistry, Pharmacology).
• 2–5 years of experience in a regulated laboratory research or testing environment.
• Minimum 2 years of Quality Assurance experience in a regulated laboratory research or testing environment.
• Experience conducting and reporting audits/inspections.

Responsibilities

• Monitor compliance with regulatory guidelines and internal procedures.
• Maintain independence from study conduct while supporting quality management system effectiveness.
• Perform risk-based QA activities aligned with regulatory and organizational expectations.
• Conduct study-based inspections (study plan verifications, critical phase inspections, study data and final report inspections).
• Prepare the QA statement for inclusion in final study reports.
• Conduct regular facility-based and process-based inspections.
• Document inspection findings and communicate results to Study Directors.
• Track and verify effectiveness of corrective and preventive actions.
• Support qualification and monitoring of vendors and subcontractors.
• Review vendor qualification documentation for compliance.
• Review quality management system documentation (SOPs, process guides, forms, templates).
• Develop, approve and maintain QA procedures and documentation, including SOPs, audit checklists, and training materials.
• Proof reading client reports.
• Regulatory liaison: serve as point of contact for regulatory inspections and audits.
• Maintain equipment inventory and manage purchases for replacements/updates.
• Maintain training records and refreshers.
• Other duties as assigned.
• This position will liaise with all other departments as needed.

Skills

Quality systems

Risk management

Documentation

Attention to detail

Communication

Independence

Teamwork

MS Office

LIMS & ELN

Audits/inspections

Education

Bachelor's degree in Life Sciences

Tools

QMS software

LIMS

ELN

Job description

Transpharmation Ltd. is seeking a Quality Assurance Officer to provide independent assurance of compliance with regulatory requirements and company standards. This role involves conducting audits, reviewing documentation, and QC of study data for studies.

You will support QA activities across projects, prepare QA statements for final reports, maintain training records, and liaise with regulatory bodies as needed.