Quality Assurance Analyst

Job summary

The QA Analyst is required:

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.

We run major acute services at:

• 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.