Senior Specialist, QA Manufacturing Operations

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 fixed term contract (FTC) Senior Specialist, QA Manufacturing Operations. Reporting to the Senior Manager, QA Manufacturing Operations, the Senior Specialist, QA Manufacturing Operations will support the execution and maintenance of the QA activities related to Manufacturing operations and site operations on extended days shift (12/7) in Cruiserath.

Key Responsibilities

• QA support of manufacturing operations (commercial operations and new product introductions)
• Batch record review and on the-floor support of manufacturing activities
• QA Operations review of events and investigations
• Authoring, review and approval of QA-related procedures
• Review and approval of functional area documentation
• Support the Disposition process for Drug Substance
• Participation in GMP reviews for new facility construction and new equipment support systems
• QA support for implementation of Manufacturing Execution System (MES) and development of batch records
• QA support for implementation for Automation changes
• QA support for validation activities
• QA support for implementation of the BMS Enterprise Resource Planning System (SAP) including data verification and integration testing for the Quality function
• Change control assessment and CAPA evaluation/CAPA close-out
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
• Support OpEx programs and champion continuous quality improvement initiatives.
• Participate in the product recall and health authority notification process in accordance with BMS procedures.
• Engage in Quality Culture initiatives

This is a 12/7 shift role.

Qualifications & Experience

• BSc in Science or related discipline
• 2 years’ minimum QA or related experience in a pharmaceutical environment
• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
• Required to work on his/her own initiative in addition to working as part of a team, and must be open to shift work. Must be able to work across a team matrix in order to meet accelerated timelines
• Excellent communication and presentation skills are essential
• Excellent time management and organisational skills along with a proven ability to multi-task
• Employees are expected to display the BMS Biopharma Behaviours, 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

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

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 [email protected]. 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/

Data Protection

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

If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.