Specialist, Quality Assurance Shop Floor, Cell Therapy

Specialist, Quality Assurance Shop Floor, Cell Therapy

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.

Position Summary

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.

Duties/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.)

Reporting Relationship

Reports to the Manager, Quality Assurance Shop Floor

Qualifications

Specific Knowledge, Skills, Abilities:

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

Education/Experience:

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

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: $40.16 - $48.67 per 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

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