Quality Control Analyst GMP / GLP

Quality Start; Over Stratton; On-site; GBP 18,000 - 21,000; Full time

Job summary

Quality Start is seeking a Quality Control Analyst in Swindon to support GMP/GLP-compliant testing, inspection and labelling of drug products. The role focuses on batch release testing and data integrity across lab systems, with emphasis on particle size analysis and HPLC Empower.

Contract is 6 months with potential extension, paid PAYE at £13.58 per hour. Clean room discipline and adherence to cGXP are essential for success in this environment.

Qualifications

• Degree or equivalent in a scientific subject.
• Hands-on experience in cGXP lab environments.
• Clean room requirements: clean-shaven, no makeup, no nail polish.
• Experience with HPLC Empower, method development, troubleshooting and validation.
• Familiar with particle size technologies (preferred).

Responsibilities

• Drive the 5S methodology within QC.
• Manage QC metrics and compliance incl deviations, CAPAs, change controls.
• Write and review SOPs and technical reports (COAs, cleaning certificates, validation protocols).
• Ensure data integrity and regulatory compliance across lab systems.
• Stay current with particle size technology advancements.
• Inspect and label commercial finished drug product batches.

Skills

CGXP lab experience

HPLC Empower

Method development

Troubleshooting

Validation

Particle size technology

Education

Degree in scientific subject

Tools

HPLC Empower

Job description

Opportunity

Are you currently working in quality control and or quality assurance? Does your experience include the testing, inspection and labelling of drugs for product release? Do you have hands on particle size analysis, analytical testing of Raw Materials, In-process, Release and Stability checks of drug products? Want to work for a large pharmaceutical company? Yes then this is the role for you!

Your role as a Quality Control Analyst GMP / GLP based in Swindon will involve inspecting and labelling commercial finished drug product batches. The position is necessary to maintain testing to support for commercial batch release.

Duties and responsibilities

• Driving the 5S methodology within QC.
• Managing QC metrics and compliance activities including deviations, CAPAs, and change controls.
• Writing and reviewing SOPs and technical reports (COAs, cleaning certificates, validation protocols, etc.).
• Ensuring adherence to data integrity and regulatory requirements across all lab systems.
• Staying current with industry innovations in particle size technology.

This is a 6 months contract which will be reviewed for a possible extension or go permanent but this is all dependent on the candidate and business performance. The PAYE rate is £13.58 per hour.

Skills

• Degree or equivalent in a scientific subject.
• Hands-on experience in cGXP lab environments.
• Need to be clean-shaven due to working in clean rooms.
• No make up, false eye lashes and nail varnish due to working in clean rooms.
• Experience with HPLC Empower, method development, troubleshooting, and validation.
• Familiar with particle size technologies (preferred).