Senior Specialist QAC Materials Management

Bristol-Myers Squibb; Cruiserath; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym

Life assurance

Job summary

Bristol Myers Squibb is seeking a Snr Specialist, QA Compliance Materials Management at the Cruiserath Biologics site. You will support material qualification and release activities for biologics and clinical pipelines, reporting to the Senior Manager, QA Compliance.

The role involves QA documentation, change controls, deviations, investigations and supplier-related activities. Ideal candidates hold a BSc in Science or related discipline with at least 3 years' QA experience in pharma/biologics,

Qualifications

• BSc in Science or related discipline with a minimum of 3 years' QA or related experience in a Biologics or Pharmaceutical environment
• Clear understanding of cGMP requirements for manufacturing and/or systems and compliance
• Knowledge of material qualification & SAP would be a distinct advantage
• Able to work independently as well as part of a matrix team to meet accelerated timelines
• Excellent communication and presentation skills

Responsibilities

• Preparation, review and approval of Material Qualification Documentation
• QA disposition of raw materials, level 1 & level 2 consumables
• Authoring, review and approval of QA-related procedures
• QA review, assessment and approval activities for Biologics Manufacture, including change controls
• Deviations/Investigations, Supplier Investigations, CAPAs
• Supplier Change Notifications and TSE Certificates
• Support establishment of Operational Excellence initiatives

Skills

QA Compliance

cGMP Knowledge

Team Collaboration

Excellent Communication

Education

BSc in Science or related discipline

Tools

SAP

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.

Position Summary

BMS Cruiserath Biologics is seeking to recruit a Snr Specialist, QA Compliance Materials Management.

Reporting to the Senior Manager, QA Compliance, the Specialist will support the material qualification and release activities for the Cruiserath manufacturing facility for its biologic's commercial portfolio and clinical pipeline.

Key Responsibilities

• Preparation, review and approval of Material Qualification Documentation.
• QA disposition of raw materials, level 1 & level 2 consumables.
• Authoring, review and approval of QA-related procedures.
• QA review, assessment and approval activities for Biologics Manufacture, as applicable, for: Change controls
• Deviations/Investigations
• Supplier Investigations
• CAPAs
• Supplier Change Notifications (SCN)
• TSE (Transmissible Spongiform Encephalopathy) Certificates
• Other associated documentation

Be a core team member of the QA Compliance Materials Management team engaging in other support activities as required.

Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Qualifications & Experience

The successful candidate must possess:

• BSc in Science or related discipline with a minimum of 3 years' QA or related experience in a Biologics or Pharmaceutical environment
• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
• Knowledge of material qualification & SAP would be a distinct advantage.
• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.
• Excellent communication and presentation skills are essential.
• Excellent time management and organizational skills along with a proven ability to multi-task.

Employees are expected to display the BMS Biopharma Behaviors, which enable them to be successful and perform at their highest level.

You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave , access to BMS Cruiserath on-site gym and life assurance

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/

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Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Le