QC Microbiology Analyst - Sterility & Bioburden Testing

Bristol Myers Squibb; Fingal; On-site; EUR 55,000 - 75,000; Full time

Job summary

Bristol Myers Squibb is seeking a QC Microbiology Analyst for the QC Microbiology Laboratory in Ireland. You will support testing of samples and maintain compliance with cGMP regulations, performing sterility, endotoxin, bioburden, and PCR-based work.

The role requires a Level 8 degree and at least 1 year in a pharma/healthcare lab. You'll work in a team-driven environment with potential 12/7 shift patterns and a competitive benefits package.

Qualifications

• The ideal candidate will hold a minimum of a Level 8 degree in Microbiology or related discipline.
• At least 1 year of experience in a pharmaceutical/healthcare laboratory or related technical function.
• Strong background in Microbiology and aseptic manufacturing is desirable but not essential.
• Excellent written and verbal communication skills are required.
• Ability to work in a team-based collaborative environment is essential.
• Sterility experience is desirable but not essential.

Responsibilities

• Perform Sterility testing on Drug Product samples.
• Perform Bacterial Endotoxin Testing on Drug Product, Drug Substance, Raw Material and Utility samples within required hold times.
• Perform Bioburden testing on Drug Substance, Raw Materials and Utility samples within required hold times.
• Perform Growth Promotion testing of media lots entering the laboratory.
• Carry out identifications of Microorganisms isolated post testing activities.
• Carry out the Minute Mouse Virus by PCR for in-process samples.
• Perform compendial verification, method transfer/validation, and routine testing of in-process, drug substance and drug product samples in accordance with applicable procedures and cGMP requirements.
• Complete all laboratory documentation in a timely and accurate manner.
• Ensure compliance with SOPs and Registered Specifications.
• Assist in authoring and reviewing documentation, including SOPs.
• Provide support to other departments to ensure qualification and production schedules are adhered to.
• Review Batch paperwork, and reconciliation of analysis performed in the laboratory.
• Ensure alert/action limit excursions are investigated according to site procedures.
• Maintain a high standard of housekeeping and safety in the laboratory.
• Perform any other activities as indicated by the Microbiology Manager.

Skills

Communication skills

Teamwork

Education

Level 8 degree in Microbiology or related discipline

Job description

Bristol Myers Squibb is seeking a QC Microbiology Analyst for the QC Microbiology Laboratory in Ireland. You will support testing of samples and maintain compliance with cGMP regulations, performing sterility, endotoxin, bioburden, and PCR-based work.

The role requires a Level 8 degree and at least 1 year in a pharma/healthcare lab. You'll work in a team-driven environment with potential 12/7 shift patterns and a competitive benefits package.