Specialist, Quality Assurance Shop Floor, Cell Therapy

Bristol Myers Squibb • Devens, MA

2d • $40 - $49 • Onsite

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 Supply Chain/Warehouse Operations. This position will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shift: NIGHT shift, 6 PM – 6 AM, Panama schedule (12-hour shift patterns with a 2-2-3 work cycle, including weekends and holidays) The Specialist, QA Shop Floor, is accountable to own quality decision making as it relates to unexpected events on the production floor, including deviation triage and determination, and involving participation in cross-functional triage meetings. The Specialist may own, review, or quality approve GxP records including but not limited to procedures, batch records, or deviations. Additionally, this role may support deviation approval, alarm approval, and review/approval of other Quality System Records as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Quality Assurance Shop Floor team to succeed.

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
• Ability to effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills
• Ability to independently make decisions based on data and facts, and to recognize when to escalate
• Active listening skills to understand diverse working perspectives
• Contributes to a positive team environment
• 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) software such as SAP; laboratory information management systems (LIMS); electronic logbooks/forms
• Basic computer skills with proficiency in MS Office
• Self-motivated and willingness to learn
• Bachelor's degree in STEM field preferred. High School diploma/Associate’s degree with equivalent combination of education and work experience may be considered.
• 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience.

Nice To Haves

• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

Responsibilities

• Provide Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations
• Able to interpret problems and effectively prepare supporting 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 per approved procedures
• Observe manufacturing operations and identify departures from procedures, cleanroom behaviors, and aseptic technique
• 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 batch records, logbooks, and/or QC testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies and escalate as required.
• Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
• Provide quality oversight for pre-planned return to service plans
• Support internal and external inspections as required
• Identify improvement opportunities and supports execution of site/team continuous improvement goals and projects
• Maintain compliance with assigned learning plan. Provide integration support for newer team members
• Participate in quality and shift meetings, as well as cross-department and cross-functional meetings; communicate in a professional manner and share data/knowledge within team by acting as a champion for quality-culture
• Build and maintain relationships with core partner functions and seek collaborative solutions
• Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (MES/Syncade, SAP, Infinity and BMSDocs (Veeva), CELabs, ValGenesis, DeltaV, Maximo, 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