Specialist, QA Manufacturing Shop Floor, Cell Therapy (Day Shift 6am-6pm Rotating Shift Schedule)

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.

About the role

This position works a rotating 2-3-2 Panama schedule (6am to 6pm), Day shift. 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 Warehouse Operations. This role will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

In the capacity of QA Shop Floor, the Specialist shall serve as one of the Quality Representatives interacting with Manufacturing, Supply Chain, Quality Control, and other supporting functions. The Specialist is accountable for quality decision-making related to unexpected events on the production floor, deviation triage, and determination. They will participate in cross-functional triage meetings, review or quality-approve GxP records (including procedures, batch records, or deviations), and support deviation approval, alarm approval, and other Quality System Records as requested by management.

Responsibilities

• Provide integration support for newer team members.
• Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge.
• Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
• Participate in quality and shift meetings.
• Build and maintain relationships with core partner functions and seek collaborative solutions.
• Share data/knowledge within the team by acting as a champion for quality culture.
• Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.).
• Work within pharmaceutical cleanroom environments.

Requirements

• Action-oriented with proficiency in decision-making, relationship-building, problem-solving, and analytical thinking.
• Ability to understand, follow, and apply internal policies, procedures, and quality principles.
• Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Ability to assess unfolding situations, diagnose problems, and propose practical solutions.
• Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work.
• Ability to work in a fast-paced team environment with changing priorities, limited information, and/or time constraints.
• Effective communication with cross-functional peers and various levels of management through technical writing and verbal skills.
• Active listening skills to understand unique working perspectives.
• Contributes to a positive team environment.
• Able to independently make decisions based on data and facts, and recognizes when to escalate.
• Seeks opportunities for improvement to quality and operational problems.
• Experience with quality management systems for handling records such as change control, product complaints, deviations, investigations, and CAPA management.
• Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.
• Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.

Qualifications

• Bachelor’s degree in a STEM field or High school diploma/associate’s degree with an equivalent combination of education and work experience.
• 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Pay

Devens - MA - US: $40.16 - $48.67 per hour 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.

Benefits

• 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:
  • 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).
  • 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.
  • 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 Year’s Day.

Schedule

Rotating 2-3-2 Panama schedule (6am to 6pm), Day shift.