Specialist QC Microbiology

Bristol-Myers Squibb; Netherlands; On-site; EUR 35,000 - 60,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a QC Analyst to support in-process, final product and stability testing, plus environmental monitoring and data verification in a regulated environment.

You will contribute to method transfer, deviations and continuous improvement while ensuring GMP compliance and proper documentation. This role is based in the Netherlands and involves working in a fast-paced QA setting.

Qualifications

• Bachelor's degree or equivalent required.
• MLO level 4 in the Netherlands required.
• 2+ years of relevant microbiological testing or QC experience in a regulated environment.
• Experience with microbiological techniques.

Responsibilities

• Perform routine testing of in-process, final product and stability samples.
• Perform environmental/facilities monitoring and microbiological testing.
• May perform testing for method transfer/verification/validation.
• Perform data verification, data review and review of GMP documentation for general methods.
• May perform document revision, project, CAPA and deviation/investigation tasks.
• Train analysts on general job duties.
• Perform other tasks as assigned.

Skills

Regulatory compliance

cGMP knowledge

Analytical thinking

Effective communication

Technical writing

Education

Bachelor's degree or equivalent

MLO level 4 Netherlands

Tools

LIMS

ELN

Laboratory data analysis systems

Job description

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.

Bristol Myers Squibb Netherlands

Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands.

The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. Check out this video if you want to know more about it!

The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team.

Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer? Join us and be a game changer!

For more information about Bristol Myers Squibb Netherlands, visit us at bms.com/nl or careers.bms.com/nl

Position Summary

Responsible for supporting QC testing for in-process, final product, stability samples and for supporting environmental and facility monitoring, including data review/verification. May assist with method transfer, documentation, deviations, investigations, and continuous improvement efforts.

Key Responsibilities

• Perform routine testing of in-process, final product and stability samples.
• Perform environmental/facilities monitoring and microbiological testing.
• May perform testing for method transfer/verification/validation.
• Perform data verification, data review and review of GMP documentation for general methods.
• May perform document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
• Train analysts on general job duties.
• Perform other tasks as assigned.

Qualifications and Experience

• Bachelor's degree or equivalent required, preferably in science.
• Netherlands: MLO level 4 required.
• 2+ years of relevant microbiological testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience with microbiological techniques

Knowledge, Skills and Abilities

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Knowledge of LIMS, ELN and laboratory data analysis systems preferred.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers.
• Experience with writing technical documents preferred.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.

Job Safety Requirements & Essential Physical Demands

• Ability to perform lifting tasks up to 20 lbs (9 kg) at floor and waist height.
• Ability to lift up to 10 lbs (4.5 kg) overhead as well as push or manoeuvre carts to transport materials between locations.
• Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
• Ability to independently don, doff, and wear required personal protective equipment such as but not limited to lab coat/frock, gloves, safety glasses/face shield for prolonged periods while performing laboratory work.
• Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals.
• Work may involve handling of dry ice, liquid nitrogen, and cryogenically cooled materials.
• Ability to use step stools while reaching and handling materials.
• Ability to work in a Biosafety Level 2 (BSL-2) environment.

The laboratory employee is responsible for performing work safely in accordance with EHSS procedures. This includes identifying and controlling risks, proper use of personal protective equipment (PPE), safe handling of chemicals and biological agents, compliance with waste and emergency procedures, and active participation in training and safety programs.

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our rol