Specialist, QA Operations Shopfloor

Bristol-Myers Squibb; Leiden; On-site; EUR 52,000 - 70,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Specialist, QA Operations Shopfloor to oversee quality on the factory floor within manufacturing, QC, warehouse and packout operations in Leiden. This on-site, shift role requires adherence to cGMP and strong collaboration with cross-functional teams.

The candidate will assess discrepancies, approve deviations, and participate in internal and external inspections while supporting newer team members and continuous improvement efforts.

Qualifications

• Bachelor’s degree in engineering or sciences, preferred.
• 0-2 years of relevant cGMP experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Experience with quality management systems preferred.

Responsibilities

• Provide Quality on-the-floor oversight to Manufacturing, QC, Warehouse and Packout operations.
• Identify departures from approved procedures & respond to issues independently, escalating more complex issues.
• Independently assess discrepancies for entry into quality system and approve deviations, as applicable.
• Perform and document operational verification per approved procedures.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Provide quality oversight to maintenance operations and support pre-approved return to service plans.
• Perform area walkthroughs to identify quality issues and support implementation of remediation.

Skills

Quality oversight

cGMP experience

Manufacturing floor

Communication skills

MS Office

Education

Bachelor’s degree in engineering or sciences

High school diploma/Associate degree

Tools

MES

ERP

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 Specialist, QA Operations Shopfloor oversees and partners with Manufacturing, Quality Control laboratories, and Warehouse Operations, to ensure compliance with Bristol Myers Squibb policies, standards, procedures, and Global current Good Manufacturing Practice (cGMP). NOTE: this is on-site and on shift role. No remote work available.

Key Responsibilities

• Provide Quality on-the-floor oversight to Manufacturing, QC, Warehouse and Packout operations.
• Identify departures from approved procedures & responding to issues independently and escalating more complex issues to senior members.
• Independently assess discrepancies for entry into quality system and approve deviations, as applicable.
• Perform and document operational verification per approved procedures.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Provide quality oversight to maintenance operations and support of pre-approved return to service plans.
• Perform area walkthroughs to identify quality issues, propose remediations and support implementation to ensure the floor and operations are in adherence with cGMP and approved procedures.
• Review manufacturing or testing records to ensure compliance with approved procedures.
• Communicate and resolve discrepancies independently and escalating as required.
• Author and review department owned documents.
• Maintain compliance with assigned learning plan.
• Support integration of newer team members.
• Support internal and external inspections as required.
• Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/ knowledge within team.
• Build relationships with specialized function

Key Competencies

• Ability to understand, follow and apply approved procedures.
• Proficient computer skills with knowledge of MS Office.
• Ability to understand problems and propose practical solutions.
• Ability to communicate effectively with cross functional peers andvarious levels of cross functional management through written and verbal skills.
• Ability to work in a fast-paced team environment with changing priorities.
• Detail oriented and task focused with ability to meet deadlines and prioritize assigned work.
• Active listening skills and ability to understand varied perspectives.
• Ability to independently make decisions and recognize the need for escalation of issues.
• Ability to seek out opportunities for improvement.

Qualifications & Experience

• Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry) is preferred.
• High school diploma/ Associate’s degree with equivalent combination of education and work experience is acceptable.
• 0-2 years of relevant cGMP experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Experience with quality management systems preferred.
• Experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP) preferred.

Disclaimer

#LI-Onsite Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.

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.

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. 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/

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. R1606245 : Specialist, QA Operations Shopfloor Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.