QC Microbiologist
Quality Control | Pharmaceutical Manufacturing | GMP Environment
We are seeking a QC Microbiologist to join a Quality Control function within a regulated pharmaceutical manufacturing environment. This role is responsible for ensuring that materials are tested for microbiological contamination in line with agreed specifications, procedures, and timelines, while acting as the subject matter expert for microbiology across the site.
Key Responsibilities
Quality, Safety & Compliance
- Perform all activities in compliance with GMP, GDP, internal quality systems, and industry standards
- Maintain a safe working environment, reporting near misses and incidents in line with procedures
- Ensure product quality through strict adherence to approved SOPs and quality systems
- Support continuous improvement initiatives and contribute to operational efficiency
- Communicate effectively with internal stakeholders to meet quality and release timelines
Technical & Operational Duties
- Perform microbiological testing of all materials to approved specifications and procedures
- Conduct Environmental Monitoring sampling and testing in line with site schedules
- Qualify microbiological laboratory equipment (URS, IQ, OQ, PQ)
- Maintain and calibrate microbiology laboratory equipment in accordance with procedures
- Maintain microbiological quality systems and associated documentation
- Author and review SOPs related to microbiological testing and support
- Provide expert input into microbiological sampling activities
- Raise and support deviations, investigations, and CAPAs
- Support internal and external audits and regulatory inspections
- Support analytical method transfers, particularly microbiological methods
- Contribute to change control activities
- Support data collection for Product Quality Reviews (PQRs) and Quality KPIs
- Undertake additional duties as required by QC management
Working Relationships
- Collaborate cross‑functionally with Quality Assurance, Manufacturing, Packaging, Supply Chain, and Regulatory teams
- Liaise with affiliated organisations and third‑party contractors as required to support product release and distribution schedules
Skills & Qualifications
- Degree in Microbiology or a related scientific discipline
- Proven experience within a Pharmaceutical QC Microbiology Laboratory
- Strong knowledge of microbiological testing techniques (e.g. water testing, microbial limits, organism identification)
- Demonstrated understanding and practical application of GMP regulations
- Knowledge of Quality Control, Quality Assurance, and Quality Systems
- Ability to interpret complex data and present clear, concise conclusions
- Strong communication and stakeholder‑management skills
- Computer literate (e.g. Word, Excel, PowerPoint)
- Sound scientific judgement and attention to detail