Senior Specialist, Quality Assurance Investigations

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 rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us

PURPOSE AND SCOPE OF POSITION:

The Senior Specialist, Quality Assurance (QA) Investigations, role at the Cell Therapy Facility (CTF) in Devens, MA will be responsible for the quality review and approval of manufacturing investigations and product complaints, in accordance with BMS policies, standards, procedures and Global cGMP. The role will provide Quality oversight and assure the quality of manufactured products are in compliance with all applicable regulations and guidelines.

Functional responsibilities include support and execution of root cause analysis and the determination of appropriate corrective/preventative actions as a result of investigation findings. This individual will also be responsible for maintenance and review of Standard Operating Procedures (SOPs) associated with the investigation program. This position is stationed in Devens, MA and reports to the Manager, Quality Assurance Investigations for the Devens CTF.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Must have knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements.

• Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.

• Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.

• Demonstrated ability to develop and maintain strong business partner relationships internally and with cross-functional teams. Able to effectively work across functional groups and teams to ensure requirements are met.

• Demonstrated background in core Quality Management System (QMS) concepts and improvement activities.

• Requires direction to complete more complex tasks; completes routine tasks with little supervision. Confident in making decisions for minor issues and routinely recognizes Quality issues and solves problems.

• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

• Uses 5-WHY, Ishikawa Diagram and other Root Cause Analysis tools to structure and aid problem solving activities within a cross-functional team determining appropriate corrective/preventative actions as a result of investigation findings.

• Represents QA in cross functional meetings.

• Able to recognize conflict and escalate to management.

• Participates as requested in the response team for audits and inspections by world health authorities.

• Working knowledge of applicable business systems including SAP, LIMS, Enterprise Asset Management, and/or Veeva Vault is desirable.

• Reviews and approves investigations, corrections and actions associated with all areas of the manufacturing process including incoming, manufacturing, facility and utility systems.

• Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports.

• Contributes to and supports the site team which prepares for, hosts, and responds to Health Authority inspection reviews and approvals of the facility and products

• Collaborates with Compliance Lead to ensure documentation in QMS systems related to complaints and investigations follow appropriate guidelines.

• Drives process improvement strategies and supports execution of site/team continuous improvement goals and projects.

• Identifies and reports any EHS, Quality or Compliance concerns and takes immediate corrective action or escalation as required

• Represents QA in cross functional meetings.

• Provides training on QA owned procedures.

EDUCATION AND EXPERIENCE:

• B.S. in a life or physical science related discipline (equivalent industry experience will also be considered).

• Minimum of 4 years of pharmaceutical experience or related GMP industry.

WORKING CONDITIONS:

• Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.).

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

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