Summary: This position is critical to maintaining quality oversight and ensuring GMP compliance in day-to-day manufacturing operations. The Senior Field QA Specialist is responsible for reviewing Manufacturing Batch Records (MBRs), performing real time on-the-floor exceptions reviews and logbooks, conducting GMP area walkthroughs, and supporting timely return-to-service (RTS) walkthroughs to confirm that manufacturing areas and equipment are properly cleaned, calibrated, and ready for production use. The role also working closely with Manufacturing Operations to investigate and resolve manufacturing issues as they arise. Additionally, this position contributes to authoring and revising quality SOPs, supporting the review and closure of no-impact manufacturing deviations, and conducting proactive area inspections and readiness reviews to uphold both internal quality standards and external regulatory requirements. This is a high-visibility, floor-based role that is integral to real-time quality assurance, batch release readiness, and audit preparedness. The absence of this resource creates increased risk for delayed batch review, reduced on-floor QA presence, gaps in RTS activities, and decreased support in deviation resolution. Shift Available: Monday - Friday, Onsite Afternoon Shift (2 p.m. - 10:30 p.m.) Responsibilities: 37Quality floor support of complex manufacturing activities 37Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs. 37Perform walkthroughs of GMP areas documenting observations and areas of concern. 37Perform training on routine facility Quality tasks for new team members. 37Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed. 37Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines. Knowledge & Skill: 37Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable. 37Knowledge of US and EU cGMP regulations and guidance. 37Knowledge of electronic or paper batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable. 37Field Quality may have business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Supply Chain, Digital Plant, Site Engineering and Manufacturing staff, as they conduct record reviews and respond to events occurring during day to day operations. 37Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Coordinates with higher level leads and/or supervisor on decisions and applies appropriate notification to management as appropriate. 37Receives assignments which require the application of a defined process to complete the assignment. As such specific assignments are allocated based upon the recipient's demonstrated capabilities with the degree of supervisory attention determined accordingly. Basic Requirements: 37Bachelor's degree in science, engineering, biochemistry or related discipline, or its equivalent is preferred. 374 years of Quality Assurance experience within the pharmaceutical or medical device industry. 37Batch record review experience. Working Conditions: 37Work is largely performed in a modern manufacturing facility where one must be aware of the presence of workplace standards including pressurized liquids gases, steam and hazardous chemicals. 37Use of Personal Protective Equipment (PPE) will be required in some portions of the facility, including appropriate gowning for working in a clean room environment. Compensation Overview: Devens - MA - US: $89,530 - $108,490 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 https://careers.bms.com/life-at-bms/. 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: 37Health Coverage: Medical, pharmacy, dental, and vision care. 37Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). 37Financial 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 37US 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) 37Phoenix, 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. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.