Senior Specialist QAC Materials Management

Bristol Myers Squibb; Ireland; On-site; EUR 60,000 - 90,000; Full time

Job summary

BMS Cruiserath Biologics in Ireland is seeking a Senior Specialist, QA Compliance Materials Management to lead material qualification documentation and QA disposition, ensuring cGMP compliance across biologics manufacturing processes.

The role requires a BSc in science with 3+ years in QA within biologics/pharmaceutical environments, strong communication and time-management skills, and the ability to work both independently and in a matrixed team. A competitive package awaits.

Qualifications

• 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 and 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.

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 (SCN), TSE certificates and related 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 (5S / Std Work / LSW / Kaizen / Problem Solving).

Skills

QA Compliance

cGMP

Material qualification

SAP knowledge

Communication skills

Time management

Education

BSc in Science or related discipline

Tools

SAP

Job description

Position Summary

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

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.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• 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

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

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/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

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 https://careers.bms.com/fraud-protection.

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

R1607779 : Senior Specialist QAC Materials Management