Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm)

Bristol Myers Squibb • Devens, MA

17h

About The Position

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 position 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, QA Shop Floor, is accountable to own quality decision making as it relates to unexpected events on the production floor, deviation triage and determination. Participation in cross-functional triage meetings. They own; review or quality approve GxP records including but not limited to procedures, batch records, or deviations. Additionally, the incumbent shall support deviation approval, alarm approval, and other Quality System Records as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed. This position reports to the Shift Manager, Quality Assurance Shop Floor. This position works a rotating 2-3-2 Panama schedule (6am to 6pm ), Day shift.

Requirements

• Must be action-oriented and proficient in decision-making, building relationships, 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 an unfolding situation, diagnose the problem, 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 with limited information and/or time-constraints.
• Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills.
• Active listening skills to understand diverse 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.
• Ability to work within pharmaceutical cleanroom environments.
• Experience with quality management systems for handling of 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.
• Bachelor's degree in STEM field. High school diploma or associate’s degree with equivalent combination of education and work experience is considered.
• 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Responsibilities

• Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
• Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
• Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members.
• Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
• Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques.
• Provide quality oversight for pre-planned return to service plans.
• Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners.
• Identify and propose improvements to programs, procedures, and practices.
• Review manufacturing batch records or QC testing records to ensure compliance with approved procedures.
• Review and provide feedback on documents such as forms, logbooks, and procedures.
• Maintain compliance with assigned learning plan. Provide integration support of 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 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.).

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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees