QA Compliance Specialist – Life Sciences

Vivo Consulting; Stone Cross; On-site; GBP 35,000 - 55,000; Full time

Job summary

Transpharmation, a dynamic preclinical contract research organization, seeks a Quality Assurance Officer to provide independent assurance of regulatory compliance and company standards. The role covers audits, documentation review, training, and QC of study data and records across studies.

Responsibilities include coordinating QA activities, preparing QA statements, supplier qualification, and maintaining GMP-like documentation.

Qualifications

• Bachelor's degree in Life Sciences.
• 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 regulatory guidelines and internal procedures.
• Perform risk-based QA activities.
• Conduct study-based inspections (study plan verifications, critical phase inspections, study data and final report inspections).
• Prepare the QA statement for inclusion in the final reports for studies.
• Conduct regular facility-based and process-based inspections.
• Document inspection findings and communicate results to Study Directors.
• Track and verify effectiveness of corrective and preventative actions.
• Support qualification and monitoring of vendors and subcontractors.
• Review vendor qualification documentation for compliance.
• Quality Management System documentation: review, develop, approve and maintain QA procedures and documentation, including SOPs, audit checklists, and training materials.
• Regulatory Liaison: serve as a point of contact for regulatory inspections and audits.
• Maintain an equipment inventory and manage/maintain as required including purchase requests for replacements or updates.
• Maintain training records and refreshers.
• Other duties as assigned.

Skills

Quality systems

Documentation

Risk-based QA

Attention to detail

Communication skills

Teamwork

Independent work

Education

Bachelor's degree in Life Sciences

Tools

Quality management software

LIMS

EDC systems

Microsoft Office

Job description

Transpharmation, a dynamic preclinical contract research organization, seeks a Quality Assurance Officer to provide independent assurance of regulatory compliance and company standards. The role covers audits, documentation review, training, and QC of study data and records across studies.

Responsibilities include coordinating QA activities, preparing QA statements, supplier qualification, and maintaining GMP-like documentation.