Quality Control; QC Analyst

Position: Quality Control (QC) Analyst

Quality Control (QC) Analyst – North Bristol NHS Trust

Quality Control (QC) Analyst –
North Bristol NHS Trust

Specialised expertise in the analysis and assessment of pharmaceutical and related products to ensure product quality for clinical use. Analysis covers chemical, physical and microbial techniques. Expertise in underpinning Quality Assurance principles affecting medicines safety.

Main Responsibilities

• 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.
• Report writing.
• 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.
• Root cause investigation.
• CAPA and Change control planning.
• Carrying out internal audits and producing audit reports.
• Developing and writing standard analytical procedures.

General Task List

• Report any deviations from documented procedures.
• Raise corrective and preventive actions as necessary.
• Carry out actions as required for quality issues.
• Write and review documented procedures (directed by Laboratory Manager).
• Assist colleagues and participate in training as necessary.
• Train and supervise others (directed by Laboratory Manager).
• Demonstrate work activities to interested parties.
• Attend and take an active part in departmental meetings.
• Plan and organise personal workload to meet department needs.
• Request stock orders as necessary.
• Be aware of health & safety issues within the workplace and comply with all appropriate guidance.
• Awareness of GLP.
• Participate in the staff appraisal scheme.
• Attend lectures and courses as requested.

QC Analyst Tasks (Band 5)

• 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.
• Participate 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 A’s for analytical tests.
• Place orders.

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

Person

Specification Education / Training / Qualifications

Essential criteria:

• First degree in a relevant science subject.

Desirable criteria:

• Membership of a professional body (e.g. Royal Society of Chemistry).
• Registered Quality Controller for Medical Gas Pipeline Systems.

Work Experience

Essential criteria:

• Several years’ experience in pharmaceutical analysis.
• Analytical projects in pharmaceutical analysis.
• Use of scientific software.
• Experience in a GMP…