Quality Assurance Analyst

NHS; Greater London; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading healthcare trust in London is looking for a Quality Assurance Analyst to ensure the integrity of analytical testing and data quality. The role involves supervising staff, conducting microbiology testing, and maintaining documentation to meet regulatory standards. With at least 5 years of relevant laboratory experience and a BSc in a scientific discipline, the ideal candidate will thrive in a collaborative environment focused on patient safety and high-quality service.

Qualifications

• 5+ years laboratory experience in hospital or industry linked to manufacturing.
• Knowledgeable in microbiological and laboratory instrumentation techniques.
• Ability to identify problems and propose solutions.

Responsibilities

• Analyze QA review and report test results for raw materials and final products.
• Undertake microbiology testing and support commissioning of new production unit.
• Supervise and train junior staff in QA/QC and analytical testing.

Skills

Microbiological techniques

Data analysis

Root Cause Analysis

Education

BSc degree in Chemistry or Pharmaceutical Science

Tools

HPLC

UV/VIS Spectroscopy

IR Spectroscopy

Job description

Go back London North West University Healthcare NHS Trust

Quality Assurance Analyst

The closing date is 30 June 2025

To be suitably qualified and experienced to undertake review of analytical/microbiology testing data, qualification/validation, monitoring and sampling on a range of media samples and facilities and provide a high-quality service to all internal and external customers in line with Trust values.

To review and maintain accurate and legible records of all quality and manufacturing activities undertaken as per current good documentation principles and GxP requirements

To use and review data from all sensitive scientific instruments required to complete the tasks with due care and attention and ensure accuracy of the generated results in line with MHRA GxP Data Integrity Guidance.

To undertake QA review/ testing (if required) of all samples within the laboratories with attention to detail

To report and investigate any deviations, out of specification results, carry out Root Cause Analysis, Corrective and Preventive Actions, and follow up as appropriate.

To carry out self-inspections as required and to supervise and train Junior staff

Main duties of the job

• Analysis, QA review, interpretation and reporting of all test results of a wide range of raw materials, intermediates and final products as required. To supervise and direct all these activities as needed.
• To undertake microbiology testing, monitoring and sampling on media samples and facilities as required
• To support the research and development for commissioning, qualification and validation of the new aseptic production unit (cleanrooms, laminar airflow cabinets and isolators). This includes protocol development, execution and reporting.
• To review/undertake microbiological observation and reporting of plate /media from monthly/In-process EM and/or operator/process validations.
• To write/review and maintain accurate and legible records of all activities undertaken as per current good documentation principles and GMP requirements
• QA review of trending of all analytical/microbiological EM data and prepare/review weekly/monthly/six monthly and yearly reports.
• Provide expert technical advice to production, QA/QC and external customers where necessary.
• To supervise and train junior staff in QA/QC, Analytical and microbiological testing requirements and procedures

About us

London North West University Healthcare NHS Trust (LNWH) cares for the people of Brent, Ealing, Harrow and beyond.

Our team of more than 8,200 clinical and support staff serve a diverse population of almost one million people.

• Northwick Park Hospital: home to one of the busiest emergency departments (A&E) in the country. The hospital provides a full range of services including the country's top-rated hyper-acute stroke unit and one of only three hyper-acute rehabilitation units in the UK
• St Mark's Hospital: an internationally renowned specialist centre for bowel disease
• Ealing Hospital: a busy district general hospital providing a range of clinical services, as well as 24/7 emergency department and urgent care centre, and specialist care at Meadow House Hospice
• Central Middlesex Hospital: our planned care site, hosting a range of surgical and outpatient services and collocated with an urgent care centre.

We are a university teaching NHS trust, in recognition of the important role we play in training clinicians of the future and bringing the benefits of research to the public.

Job responsibilities

To view the main responsibility, please see the attached the Job Description and Person Specification.

Person Specification

• BSc degree in Chemistry, Pharmaceutical Science or relevant scientific discipline
• Minimum of 5 years laboratory experience in hospital or industry linked to a manufacturing unit

Education/Qualification

• BSc degree in Chemistry, Pharmaceutical Science or relevant scientific discipline
• Minimum of 5 years laboratory experience in hospital or industry linked to a manufacturing unit
• Knowledgeable in different microbiological and laboratory instrumentation techniques i.e. HPLC, ICAP, UV/VIS, IR Spectroscopy, Polarimetry, Refractometry etc.
• Demonstrated ability identify problems, analyse root cause and propose solutions
• Experience of working to Pharmacopoeial methods and specifications
• Knowledgeable in environmental monitoring of clean rooms

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.

Employer name

London North West University Healthcare NHS Trust