Jobid=628543819316134913 (0.0995)
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Position summary
The Specialist Quality Assurance Disposition is responsible for supporting quality and disposition activities at the Cell Therapy Facility (CTF) in Leiden, The Netherlands, in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures and global current Good Manufacturing Practice (cGMP). The role aids in the routine and timely release of drug product and assure the quality of manufactured products is in compliance with all applicable regulations and guidelines.
Functional responsibilities include preparing deliverables for product release within the inventory management system (SAP), ensuring accurate and timely maintenance and review of batch record documentation, providing operations shopfloor oversight, and performing document issuance for manufacturing. This individual is also responsible for reviewing departmental Standard Operating Procedures (SOPs) and Work Practices.
Responsibilities
Procedures, training, and business processes supporting drug product disposition.
Prepares documentation and deliverables per SOPs required for drug product disposition.
Verify accuracy and acceptability of drug product documentation, such as Certificate of Analysis or deviation reports, to support drug product lot disposition.
Perform the review of lot genealogy for all raw materials and components used in each lot to ensure that they are approved and released.
Works in electronic systems such as SAP, Learning Management, and Document Management systems.
Leads troubleshooting sessions with internal and external stakeholders when required.
Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
Provides guidance to less experienced staff with atypical events during day-to-day operations.
Qualifications
Specific Knowledge, Skills, Abilities:
Experience with cGMP manufacturing, Quality, and/or compliance is desired.
Previous work experience where attention to detail and personal accountability were critical to success.
Strong communication skills and the ability to follow written and verbal instructions.
Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
Knowledge of electronic systems including any of the following preferred: SAP, Veeva, LIMS/Celabs, Infinity, and electronic batch recording.
Education/Experience/Licenses/Certifications:
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.
4+ years of directly relevant experience in a regulated cGMP environment. Previous quality experience is preferred.
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