Senior Quality Control Analyst - Microbiology

Senior Quality Control Analyst - Microbiology

RoslinCT

Edinburgh, United Kingdom

Your new role

An exciting opportunity for a Senior Quality Control Analyst – Microbiology to join our Quality team.

• You’ll be responsible for supporting sample flow with the microbiology laboratory.
• Ensuring all processes are subjected to appropriate levels of microbiological sampling and review.
• Leading investigations on incidents of product contamination, or of abnormal levels of microorganisms in EM samples.
• Environmental monitoring of GMP clean rooms and trending of the data generated.
• Establishing suitable methods for identification of microorganisms, ensuring accurate and timely reporting.
• Monitoring trends and emerging technologies, introducing relevant innovations in-house.
• Reviewing regulatory standards to maintain compliance and ensure new methodologies align with current requirements.
• Supporting QC batch release of cellular therapy products with performing and co-ordinating QC batch release testing as required.
• Involvement in the day-to-day running of the QC laboratories to ensure a high standard of organisation is always observed.
• Completing GMP documentation including Incident Reports, Change Controls and Risk Assessments.
• Perform tasks as expected by the QC Microbiology Manager.

About you

• Minimum of 4 years’ experience working within a GMP Microbiology environment.
• Strong technical expertise in Microbiology, with proven experience in performing speciation of microorganisms to genus level.
• Hands-on experience conducting Environmental Monitoring within GMP cleanroom environments.
• Experience performing a range of cell characterisation and safety assays.
• Excellent attention to detail, taking responsibility for continually setting high standards.
• Exceptional oral and written communication skills, between members of QC staff and RoslinCT employees.
• Excellent organisational and planning skills, with the ability to plan ahead while delivering results to deadline.

Qualifications

• A degree in Microbiology or equivalent qualification and experience is required.
• A post graduate qualification is desirable.