Specialist, QA Operations Shopfloor

Bristol-Myers Squibb; Netherlands; On-site; EUR 45,000 - 65,000; Full time

Job summary

Bristol Myers Squibb Netherlands seeks a QA Operations Shopfloor Specialist to oversee manufacturing, QC, warehouse, and packout activities on-site. You will ensure adherence to cGMP, participate in inspections, and collaborate with cross-functional teams to maintain quality across the floor.

The role requires a degree in engineering or life/physical sciences and up to 2 years of cGMP experience, with exposure to MES/ERP systems and strong attention to detail.

Qualifications

• Bachelor's degree in engineering or life/physical sciences preferred.
• 0-2 years of relevant cGMP experience.
• Experience with MES/ERP systems preferred.

Responsibilities

• Provide Quality on-the-floor oversight to Manufacturing, QC, Warehouse and Packout operations.
• Identify departures from approved procedures and respond independently; escalate complex issues.
• Independently assess discrepancies for entry into quality system and approve deviations.
• Perform and document operational verification per approved procedures.
• Observe manufacturing operations and identify departures from clean room behaviors.
• Provide quality oversight to maintenance operations and support return to service plans.
• Perform area walkthroughs to identify quality issues and support remediations.
• Review records to ensure compliance with approved procedures.
• Communicate and resolve discrepancies independently and escalate 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 meetings and share data within the team.
• Build relationships with specialized function.

Skills

MS Office

Communication

Detail oriented

Problem solving

Education

Bachelor's degree in engineering or life/physical sciences

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 escalat 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.