Quality Control; QC Analyst

Main duties of the job

• Providing accurate, reliable results from the chemical, physical and microbiological analysis of products to allow assessment of product quality.
• Completing project work to a timescale
• Developing and validating analytical methods to produce robust techniques
• Training of staff
• Performing formulation and stability studies on pharmaceutical products and components
• Keeping up to date with knowledge in pharmaceutical analysis
• Carrying out analysis off-site as required, including environmental monitoring and medical gas testing.
• Contributing to the continued regulatory compliance of the laboratory through various QA tasks
• Deviation reporting
• CAPA and Change control planning
• Carrying out internal audits and producing audit reports
• Developing and writing standard analytical procedures.

North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building  are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialities. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.

North Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.

For a more detailed job description, main responsibilities, and Person Specification, please refer to the job description document attached to this vacancy.

QC Analyst tasks (Band
5)

The following is a list of QC analyst tasks. It may be adjusted as appropriate provided agreement is reached. A Band 5 analyst should be able to carry out the majority of routine analysis and R&D projects with minimal supervision/guidance.

• Carry out routine analysis according to documented procedures.
• Validate analytical methods according to documented procedures.
• Develop analytical methods according to documented procedures.
• Carry out stability studies according to documented procedures.
• Carry out projects according to documented procedures.
• Participates with task rotation with other QC analysts in the team.
• Record accurate results.
• Report and investigate out of specification results where required.
• Maintain and improve scientific knowledge through training and literature resources.
• Monitor and calibrate laboratory equipment and instrumentation according to internal programme.
• Plan and organise personal workload to meet department needs.
• Prepare reagents as necessary.
• Maintain laboratory in clean and tidy condition.
• Carry out routine environmental monitoring of aseptic suite as required.
• Provide support and cover for the following tasks when necessary:
• Participate in sample management, e.g. Book-in samples according to documented procedures.
• Unpack and store received goods.
• Carry out routine monitoring checks, e.g. temperatures, clean room pressures.
• Weekly disposal of tested samples for chemical analysis
• Disposal of expired reagents
• Generate C of As for analytical tests
• Place orders.
• Take minutes at meetings.
• Process leader Tasks.

The QC Analyst role includes being a process leader for a limited number of analytical areas. This involves covering things such as queries, training, routine audit including competency assessment and nonconformities etc. They will need to become familiar with the relevant regulations and the status of the area in terms of compliance and risk. The process leader will plan, or be involved in planning actions to correct any failings or make improvements in their area.

• First degree in a relevant science subject
• Membership of a professional body (e.g. RSC)
• Registered Quality Controller for Medical Gas Pipeline Systems

• Several years  experience in pharmaceutical analysis
• Analytical projects in pharmaceutical analysis
• Use of scientific software
• Experience in a GMP environment
• Quality assurance and use of quality management systems
• Supervisory and training experience

• To be able to pay attention to detail
• To have good organisational skills
• To be able to show initiative
• The ability to solve technical problems
• Good Team worker
• To be familiar with the principles of Good Laboratory Practice
• Knowledge of laboratory health and safety
• Current valid driving licence

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.