Specialist, QA Disposition

Qabird; Leiden; On-site; EUR 65,000 - 90,000; Full time

Job summary

The Specialist Quality Assurance Disposition at Bristol Myers Squibb supports quality and disposition activities at the Cell Therapy Facility (CTF) in Leiden, The Netherlands, ensuring cGMP compliance and timely drug product release. You will prepare deliverables in SAP and maintain batch records, while reviewing SOPs and supervising day-to-day operations.

Qualifications include 4+ years in a regulated environment, a relevant bachelor’s degree, and strong attention to detail with effective

Qualifications

• Bachelor's degree in engineering or life/physical science preferred.
• 4+ years of directly relevant experience in a regulated cGMP environment.
• Strong attention to detail and personal accountability.

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.

Skills

cGMP manufacturing

Attention to detail

Communication skills

Team collaboration

Electronic systems

Education

Bachelor's degree in engineering

Life or physical science degree

High school diploma / Associate’s with equivalent experience

Tools

SAP

Veeva

LIMS/Celabs

Infinity

Job description

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 assures 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.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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.

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 careers.bms.com/fraud-protection.

Any data processed in connection with the role application will be treated in accordance with applicable data privacy policies and regulations.

R1604026: Specialist, QA Disposition