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The Senior Specialist, Field Quality Assurance Manufacturing, is responsible for supporting shop-floor activities in manufacturing operations at Devens in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs). Functional responsibilities include triaging and supporting the resolution of unexpected events in conjunction with area owners and technical SMEs; proactively monitoring process performance and identifying improvements to advance standards of quality; conduct routine reviews and approvals of GxP documents including, but not limited to electronic batch record review, SOPs, logbooks, and deviation records; executing operational tasks in the electronic batch records such as but not limited to disposition of incoming apheresis patient material.
The Field Quality Assurance Manufacturing team is primarily responsible for oversight of production and adjacent activities which support the creation of autologous Cell Therapy drug products. Individuals of this team are expected to have a presence on-the-floor during which they apply knowledge of cGMP, BMS policies, and regulatory requirements to ensure patient safety. Team members are expected to partner routinely with counterparts in manufacturing to assess and continuously improve the general state of the facility and operations. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Field Quality Assurance team to succeed as we are often the first members of the Quality Unit to be contacted for routine and non-routine activities supporting operations.
Duties / 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 & respond to complex issues independently while escalating critical issues to management.
• Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
• Develops, reviews and/or approves temporary actions and non-routine procedures for event response.
• Observe manufacturing operations and identify gaps or departures from procedures, cleanroom behaviors and aseptic techniques.
• Provide quality oversight for non-routine maintenance work. Review and approve return to service plans.
• Co-ordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans with area owners.
• Own shift-actions for department, propose and drive improvements to programs, procedures, and practices.
• Review manufacturing batch records or QC testing records to ensure compliance with approved procedures.
• Author, review and approve procedural documents, forms, logbooks and other GMP documents.
• Maintain compliance with assigned learning plan. Provide guidance and training to other QA personnel.
• 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.
• Lead shift meetings and represent function at cross-functional meetings as needed.
• Build and maintain strong relationships with multiple functions outside core function and seek collaborative solutions.
• Share data/knowledge within and across teams by acting as a champion for quality-culture and learning.
Specific Knowledge, Skills, Abilities:
• Must be action-oriented and skilled in decision-making, building relationships, problem-solving, coaching others, and analytical thinking.
• Ability to research, understand, interpret, and apply internal policies, cGMP and quality principles.
• Knowledge of quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Ability to interpret data & results, understand complex problems with multiple variables and articulate practical solutions.
• Detail-oriented and task-focused with ability to meet deadlines and support the prioritization of teamwork.
• Ability to work in a fast-paced team environment and lead peers through changing priorities with limited information and/or time-constraints.
• Excellent technical writing and verbal skills, and ability to present technical data effectively based on target audience.
• Ability to negotiate and influence across the matrix to craft mutually beneficial solutions.
• Ability to motivate and foster a positive team environment.
• Exhibit strong decision-making ability and analytical thinking while maintaining compliance and quality.
• Proactively finds solutions to quality and operational problems by creative thinking and innovative solutions.
• Ability to work within pharmaceutical cleanroom environments.
• Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
• Demonstrated experience 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.
• Ability to learn and work with new computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
Education/Experience/ Licenses/Certifications:
• Bachelor's degree in STEM field. High school diploma or associate’s degree with equivalent combination of education and work experience is considered.
• 4+ years of relevant cGMP experience with 1+ year of manufacturing site experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
This position is night shift 6:00 p.m. to 6:00 a.m. The shift rotates on a bi-weekly Panama schedule”.
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.
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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations
