Quality Control Analyst - BHP

An exciting opportunity has arisen for a Quality Control Analyst - Microbiology within Pharmacy Technical Services at Barts Health NHS Trust. Based at The Royal London and St Bartholomew's Hospitals, the post holder will work within the QC Microbiology team, supporting high-quality aseptic services and ensuring the highest standards of product quality and patient safety. The role involves working collaboratively with Production, Quality Assurance, and multidisciplinary teams to maintain compliance with Good Manufacturing Practice (GMP) and regulatory requirements. The post holder will contribute to the Quality Management System (QMS), including environmental monitoring, microbiological testing, and the investigation and escalation of out-of-specification (OOS) results and environmental monitoring excursions. Key responsibilities include microbial identification, trend analysis, and supporting sterility assurance activities across aseptic and radiopharmacy units. The role also involves managing deviations, CAPAs, and change controls, alongside maintaining controlled documentation such as SOPs and reports. The post holder will support audit readiness, continuous improvement initiatives, and internal quality reviews while demonstrating strong technical microbiology knowledge and attention to detail in a regulated environment. This role requires excellent organisational and communication skills, with a strong commitment to quality, compliance, and patient safety.

Main duties of the job

• Conduct environmental monitoring of cleanroom areas (Grade A D) to ensure aseptic compliance.
• Raise and assist in investigating out of limit (OOL) and out of specification (OOS) results.
• Generate monthly and annual trend analyses and report KPIs to the quality leadership team.
• Review, draft, and maintain Standard Operating Procedures (SOPs).
• Raise deviations in the QMS system and lead minor and major investigations. Support critical deviations, assist in defining corrective and preventive actions (CAPAs), and ensure effective implementation following excursion reports.
• Ensure audit readiness and contribute to internal audits and self inspection programmes.

Person Specification Qualifications

• Degree in Microbiology, Biotechnology, Pharmaceutical Science, Biological Sciences or equivalent BSc
• Science Manufacturing Technician (SMT) Level 3
• Level 3 Diploma in Principles and Practice for Pharmacy Technicians
• Member of the RSciTech council
• Registration with General Pharmaceutical Council as a Pharmacy Technician
• Membership of Royal society microbiology or related professional body.

Experience

• Experience in GMP pharmaceutical microbiology environment (aseptic facilities in industry or NHS manufacturing unit or GLP laboratory
• Demonstrate experience in performing microbiological excursion investigations.
• Previous experience in QMS such as deviations, investigation, CAPAs and change controls related to Microbiology subject
• Previous experience in sterile manufacturing.
• Experience in a licensed pharmaceutical testing laboratory

Knowledge

• Up to date knowledge of legislation relevant to pharmacy practice, e.g. annex 1, DMRC drug recall, Health and Safety at Work.
• Understanding of stock control systems.
• Understanding the importance of adherence to SOPs and Legislation
• Knowledge of cGMP/GLP, Micro Quality Control
• Knowledge with environmental monitoring programs for aseptic manufacturing processes
• Demonstrate knowledge of COSHH and Health and Safety at Work.

Skills

• Excellent interpersonal skills and ability to motivate self and others
• IT literate and able to use Microsoft office
• Excellent verbal and written communication skills
• Organisation and prioritisation of workload
• Ability to problem solve
• Methodical attention to detail
• Good numeracy skills, able to perform calculations.
• Supervisory and mentoring skills, including ability to give effective feedback to all levels of staff.
• Practical microbiological laboratory skills
• Report Writing

Other

• Basic DBS check
• Able to meet deadlines.
• Understand the principles of ALCOA
• Demonstrate good aseptic techniques.
• Patient safety focus and good team player
• Flexible and calm under pressure
• Good time keeping
• Interested in expanding knowledge and self-development.
• Demonstrate professional attitude.
• Awareness of needs of confidentiality
• Adhering to Trust Values

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.