Associate II, QASF in Devens, MA

Bristol Myers Squibb is seeking an Associate II, QASF to provide 24x7 Quality collaboration and oversight for site operations including Manufacturing, Quality Control, and Supply Chain in Devens, MA. This role ensures compliance with BMS policies, standards, procedures, and Global cGMP. Responsibilities include on-the-floor oversight, operational verification, identifying and resolving quality issues, reviewing records, and supporting continuous improvement. The position requires 0-2 years of cGMP experience and a STEM degree is preferred.

Must Have

• Provide Quality on-the-floor oversight to Manufacturing/QC/Supply Chain Operations
• Ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP
• Perform and document operational verification
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques
• Review manufacturing or testing records for compliance
• Communicate and resolve discrepancies
• Maintain compliance with assigned learning plan
• 0-2 years of relevant cGMP experience
• Ability to understand, follow, and apply approved procedures
• Basic computer skills with knowledge of MS Office
• Ability to communicate effectively

Good to Have

• Bachelor's degree in STEM field
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
• Ability to understand problems and propose practical solutions
• Ability to work in a fast-paced team environment with changing priorities
• Detail oriented and task focused, with the ability to meet deadlines and prioritize assigned work
• Ability to recognize the need for escalation of issues
• Self-motivated and willingness to learn

Perks & Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care
• Wellbeing Support: BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
• Paid Time Off: flexible time off (unlimited for exempt), 11 paid national holidays, and 3 optional holidays (for non-exempt/hourly)
• Unlimited paid sick time (based on eligibility)
• Up to 2 paid volunteer days per year (based on eligibility)
• Summer hours flexibility (based on eligibility)
• Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
• Annual Global Shutdown between Christmas and New Years Day

Job description

Life at BMS

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. 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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Supply Chain Operations.

The Associate II, QASF role will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

Shifts Available:

6am – 6pm, rotating schedule including holidays and weekends, onsite

Responsibilities:

• Provide Quality on-the-floor oversight to Manufacturing/ QC/ Supply Chain Operations & responding to minor issues or escalating to senior members.
• Perform and document operational verification per approved procedures.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Provide quality oversight to maintenance operations and support pre-approved return to service plans.
• Perform area walkthroughs to identify quality issues and support remediation to ensure the floor and operations are in adherence with cGMP and approved procedures.
• Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies and escalate as required.
• Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
• Maintain compliance with assigned learning plan.
• Support internal and external inspections as required.
• Contribute to the assessment of discrepancies and initiation of quality events.
• Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/ knowledge within team.
• Build relationships within direct team and partner functions.

Knowledge, Skills, Abilities:

• Ability to understand, follow, and apply approved procedures
• Possess basic computer skills with knowledge of MS Office
• Ability to understand problems and propose practical solutions
• Ability to communicate effectively with cross functional peers and direct management through written and verbal skills
• Ability to work in a fast-paced team environment with changing priorities.
• Detail oriented and task focused, with the ability to meet deadlines and prioritize assigned work.
• Ability to recognize the need for escalation of issues.
• Self-motivated and willingness to learn

Basic Requirements:

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 0-2 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

BMSCART

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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.

**Compensation Overview:**

Devens - MA - US: $35.45 - $42.95per hour

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

​Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

\*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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 a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

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

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.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1596495 : Associate II, QASF in Devens, MA