Specialist, QC Microbiology

Bristol Myers Squibb; Fingal; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Communication skills

Teamwork

Ausbildung

Level 8 degree in Microbiology or related discipline

Jobbeschreibung

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

The Role

BMS Cruiserath Biologics is seeking to recruit a QC Microbiology Analyst within the QC Microbiology Laboratory. Reporting to the QC Microbiology Manger, the QC Microbiology Analyst will be responsible for supporting site activities related to Product Testing, performing testing of samples and laboratory duties in accordance with cGMP regulations.

Responsibilities will include (but not limited to):

• Performing Sterility testing on Drug Product samples.
• Performing Bacterial Endotoxin Testing on Drug Product, Drug Substance, Raw Material and Utility samples within required hold times.
• Performing Bioburden testing on Drug Substance, Raw Materials and Utility samples within required hold times.
• Performing Growth Promotion testing of media lots entering the laboratory.
• Carrying out identifications of Microorganisms isolated post testing activities.
• Carrying out the Minute Mouse Virus by PCR for in-process samples.
• Performing 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.
• Completing all laboratory documentation in a timely and accurate manner.
• Compliance with Standard Operating Procedures and Registered Specifications.
• Assisting in authoring and reviewing documentation, including SOPs.
• Providing support to other departments to ensure qualification and production schedules are adhered to.
• Reviewing Batch paperwork, and reconciliation of analysis performed in the laboratory.
• Ensuring that any alert/action limit excursions are investigated according to site procedures.
• Ensuring a high standard of housekeeping and safety is maintained in the laboratory.
• Performing any other activities as indicated by the Microbiology Manager.

Qualifications and Experience required

• The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.
• At least 1 years’ experience in a pharmaceutical / healthcare laboratory or related technical function.
• A strong background in Microbiology and aseptic manufacturing is desirable but not essential.
• The successful candidate must demonstrate excellent written and verbal communication skills.
• The ability to work in a team based collaborative environment is essential.
• Sterility experience is desirable but not essential.

Note: This candidate may be required to work a 12/7 shift pattern.

Why you should apply

• You will help patients in their fight against serious diseases
• You willbe part ofa company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave,life assurance and on-site gym.

#LI-Onsite

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1608163 : Specialist, QC Microbiology