Associate, QC Systems and Support

Biopharma Careers; Leiden; On-site; EUR 42,000 - 55,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking an Associate QC Systems and Support to plan and perform sampling and visual inspection of incoming goods, ensuring materials meet quality standards prior to use or distribution. You will support GMP documentation review, data verification, and maintain sample tracking using CELabs, SAP, and SmartQC.

The role requires attention to detail, knowledge of cGMP, and capability to work in a fast-paced lab, training others, and contributing to CAPAs and

Qualifications

• Attention to detail and organizational skills required.
• Ability to understand and apply Global Regulatory and cGMP requirements.
• Experience with writing technical documents preferred.
• Knowledge of LIMS, ELN and laboratory data analysis systems preferred.

Responsibilities

• Perform routine management of in-process, final product and stability samples and QC data.
• Maintain sample tracking, labeling, and chain of custody records.
• Support GMP documentation review and data verification for method trending.

Skills

Attention to detail

GMP knowledge

Data verification

Communication

Teamwork

Problem solving

Education

MLO level 4

Tools

CELabs

SAP

SmartQC

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

The Associate QC Systems and Support is responsible for planning and performing sampling and visual inspection of incoming goods, ensuring materials meet quality standards prior to use or distribution. This role supports GMP documentation review, data verification, and method trending while contributing to CAPAs, deviations, and continuous improvement efforts. The Associate maintains sample tracking, chain of custody, and inventory records in accordance with written procedures, coordinates external lab shipments, and utilizes electronic systems such as CELabs, SAP, and SmartQC to perform and document activities. Additional responsibilities include maintaining a safe and organized lab and training others on general job duties.

Duties/Responsibilities

• Perform routine management of in-process, final product and stability samples and QC data throughout the sample lifecycle from receipt to disposition. Performs periodic sample and data inventory maintenance activities.
• Ensure samples and materials are appropriately labelled and maintain sample tracking, labelling and chain of custody records in accordance with written procedures.
• Perform data compilation, GMP documentation review, and data verification to support method trending and GDocP adherence.
• Maintain inventory and support distribution of QC samples and materials to functional groups as scheduled or requested. Record performance metrics for the sample management group.
• Plan and perform sampling and visual inspection of incoming goods.
• Organize shipment of samples to outside testing labs, as needed.
• Support document revision, project, CAPA and deviation/ investigation related tasks and/or continuous improvement efforts.
• Maintain a safe and organized lab by performing routine housekeeping and maintenance activities, including equipment cleaning, restocking supplies, and solution preparation.
• Use electronic systems such as CELabs, SAP, SmartQC to perform and document the activities.
• Train others on general job duties.
• Perform other tasks as required to support the QC laboratories.

Reporting Relationship

The Technician QC Systems and Support will report into QC Management.

Qualifications

Specific Knowledge, Skills, Abilities :

• Attention to detail and demonstrated organizational skills.
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs.
• Ability to work in a fast-paced team environment, meet deadlines and prioritize work.
• Experience with writing technical documents preferred.

Education/Experience/ Licenses/Certifications :

• NL: MLO level 4 or higher preferred, equivalent combination of education and work experience may be considered. Two or more years of relevant experience in a regulated environment.
• An equivalent combination of education and experience, preferably in a regulated environment will be considered.
• Demonstrated experience in LIMS and knowledge of Chain of Identity and Chain of Custody.
• Demonstrated experience with basic laboratory techniques and basic laboratory safety practices.
• Knowledge of LIMS, ELN and laboratory data analysis systems preferred.
• Knowledge of basic electronic systems (email, MS Office, etc.) required.

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 maneuver 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.

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

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 workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in 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.

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.

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R1604892 : Associate, QC Systems and Support