Quality Assurance Specialist

Main Purpose of Job

To develop and implement Quality Assurance (QA) strategy and lead QA activity within a GMP-regulated Quality Control (QC) Testing Laboratory. The QA Specialist ensures all laboratory operations equipment and computerized systems are compliant with regulatory standards company procedures and client requirements. The role involves reviewing laboratory documentation managing qualification and validation activities and maintaining the Quality Management System (QMS) to ensure the integrity and reliability of analytical results provided to clients.

Main Duties of Postholder

1. Quality Oversight and Compliance

• Develop and implement new QA strategy for implementation of new GMP capability.
• Lead QA activity for the QC testing laboratory to ensure compliance with GMP company policies and client-specific quality agreements.
• Review and approve analytical test records raw data and certificates of analysis to ensure compliance with GMP and client requirements.
• Review and support investigations for deviations OOS/OOT results and non-conformances ensuring thorough root cause analysis and effective CAPA implementation.
• Conduct internal audits and participate in external audits (e.g. MHRA FDA customer audits).
• Monitor compliance with data integrity and Good Documentation Practice (GDP) standards.

2. Equipment Qualification

• Develop implement and lead strategy for equipment qualification activities (IQ/OQ/PQ) for analytical and laboratory instruments (e.g. HPLC GC balances etc.).
• Ensure qualification protocols and reports are accurate complete and compliant with GMP and regulatory expectations including current data integrity requirements.
• Maintain up-to-date qualification and calibration records within the equipment lifecycle management system.

3. Computer Systems Validation (CSV)

• Develop implement and lead Computer Systems Validation activities for laboratory software (e.g. LIMS CDS balances and environmental monitoring systems).
• Manage validation deliverables including URS validation plans test scripts and reports in accordance with Annex 11 and 21 CFR Part 11 requirements.
• Ensure validated state and data integrity of all computerized systems are maintained throughout their lifecycle.
• Conduct periodic reviews and assessments of laboratory systems to ensure ongoing compliance.

4. Documentation and Quality Systems

• Ensure maintenance of the Quality Management System (QMS) including document control change control deviation and CAPA processes.
• Review and approve controlled documents such as SOPs forms and templates.
• Contribute to continuous improvement of quality systems and processes within the contract testing environment.

5. Training and Continuous Improvement

• Develop and deliver GMP GDP and data integrity training to laboratory staff as required.
• Promote a culture of quality and continuous improvement across the laboratory.
• Keep abreast of current regulatory guidelines (e.g. EU GMP ICH Q10 MHRA Data Integrity guidance FDA 21 CFR) and identify compliance gaps and propose pragmatic solutions.

Person Specification

Education/Experience/Skills

Essential

• Degree in a relevant scientific discipline (e.g. Chemistry Biochemistry Pharmaceutical Science).
• Minimum 3 years experience in a GMP-regulated environment preferably within a contract testing or pharmaceutical QC laboratory.
• Practical experience with equipment qualification (IQ/OQ/PQ) within a GMP laboratory.
• Demonstrated involvement in computer systems validation (CSV) aligned with Annex 11 / 21 CFR Part 11.
• Strong knowledge of GMP GDP and data integrity principles.
• Experience reviewing analytical and laboratory documentation for compliance.

Desirable

• Experience with client audits and regulatory inspections (MHRA FDA etc.).
• Working knowledge of quality systems such as deviations CAPAs and change controls.
• Working knowledge of GAMP 5 principles and risk-based validation approaches.
• Understanding of analytical techniques such as HPLC GC and spectroscopy.

Other Skills

• Strong attention to detail and commitment to quality and data integrity.
• Excellent communication and interpersonal skills with the ability to collaborate across functions.
• Proficient in document review and GMP record keeping.
• Analytical and problem-solving mindset with a proactive approach.
• Ability to interpret and apply GMP guidance pragmatically.
• Ability to prioritise and manage multiple tasks in a fast-paced client-driven environment.
• Proficient in Microsoft Office and laboratory informatics systems.

Additional notes/Requirements

• Office and laboratory-based work within a GMP-regulated contract testing facility.
• Occasional flexibility required to support audits or urgent QA reviews.
• Part of the facility is located up 1 flight of stairs with no lift access.

We will not consider the use of 3rd party recruitment agencies for the sourcing of candidates for this position.

The James Hutton Institute is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

The James Hutton Institute is a: Stonewall Diversity Champion; Athena SWAN Silver Status Holder; Disability Confident Committed Employer and a Living Wage Employer.

The James Hutton Institute is Happy to Talk Flexible Working.