Quality Control Analyst - BHP

Job overview

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

Detailed job description and main responsibilities

We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager.

The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents, please view the attachment/s below.