Senior Quality Specialist

Aurora Lifesciences is partnered with a regulated medical device manufacturer who is seeking an experienced laboratory based Senior QA Specialist contractor to provide Quality Assurance and technical laboratory support across Chemistry and Microbiology activities.

The Senior QA Specialist contractor will support laboratory compliance, environmental monitoring, documentation review, investigations, validation activities, sterilisation oversight, and data integrity requirements.

This assignment is suited to a hands-on laboratory professional with experience in regulated medical device, pharmaceutical, biotechnology, diagnostics, or life sciences manufacturing environments.

Key Deliverables as the Senior QA Specialist:

• Complete routine solution analysis, microbiological testing, chemical testing, and release activities for production use.
• Complete environmental monitoring, biocontamination control, and controlled environment certification activities.
• Review laboratory data, test results, records, and documentation for accuracy, completeness, and compliance.
• Support good documentation practice, data integrity, and laboratory record retention requirements.
• Complete laboratory equipment calibration, maintenance, qualification, and troubleshooting.
• Prepare, review, and support protocols and reports for validation, stability, shelf-life, and laboratory studies.
• Support sterilisation-related activities, including documentation review, annual reviews, revalidation, and process oversight.
• Review contract laboratory testing, including finished product endotoxin and microbiology testing.
• Support investigations relating to deviations, out-of-specification results, equipment failures, and laboratory non-conformances.

Key Skills Required for the Senior QA Specialist:

• Practical knowledge of microbiology laboratory controls, environmental monitoring, biocontamination control, and laboratory documentation.
• Experience supporting investigations, deviations, OOS results, CAPA, validation, stability studies, or sterilisation activities.
• Strong technical judgement with the ability to interpret data, identify trends, and draw clear conclusions.
• Good understanding of good documentation practice, data integrity, and quality system expectations.
• Ability to prepare clear investigation reports, protocols, technical summaries, and validation documentation.

About

This is an fully on site role based within a laboratory, so experience working in a regulated biotechnology, diagnostic, or medical device manufacturing environment is essential.