About the vacancy
Production
Quality Assurance
Compliance
Oncology & Hematology
Cell Therapy
About Your Next Job
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).
About Your Next Colleagues
Our employees are passionate about making a difference in patients’ lives. This unwavering commitment gives us a distinct advantage in delivering life-saving treatments to patients, faster.
About Your Tasks and 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 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 and cross-functional meetings, communicate in professional manner and share data/ knowledge within team.
Build relationships with specialized function
About Your Skills and 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.
Where Molecules Meet Opportunities
Mentorship, leadership, growth and inclusion. These are just some of the benefits of a career with BMS.
Contact person
Talent Acquisition
At Bristol Myers Squibb, your work helps people prevail over serious diseases. From the scientists behind the microscope to the analysts behind the data, everyone at BMS is working to make an impact. And while our work transforms the lives of patients, it also transforms the lives and careers of our people.
This isn’t easy work, but it is uniquely interesting. You’ll rewrite the rules, solve the toughest challenges, and create miracles.
The BMS Leiden manufacturing facility is our first European site for CAR T cell therapies, joining our global network of facilities transforming care for patients with blood cancer and other serious diseases. Equipped with the latest technology and state-of-the-art production facilities, the facility represents our commitment to ensuring supply of CAR T therapies.