Quality Specialist

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. 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) Duties / Responsibilities Provide quality on‑floor oversight and triage unexpected events with Manufacturing, Quality Labs and Supply Chain operations. 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 behaviours 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 support execution of site/team continuous improvement goals and projects. Maintain compliance with assigned learning plan and 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 the 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 Action‑oriented and proficient decision‑making, building relationships, problem‑solving and analytical thinking. 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. Assess an unfolding situation, diagnose the problem and propose practical solutions. Detail‑oriented and task‑focused with the ability to meet deadlines and prioritise assigned work. Work effectively in a fast‑paced team environment with changing priorities and limited information. Communicate with cross‑functional peers and various levels of management through technical writing and verbal skills. Make independent decisions based on data and facts, and recognise when to escalte. Active listening skills to understand unique working perspectives. Contribute to a positive team environment. Seek opportunities for improvement to quality and operational problems. 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 MES for electronic batch records; ERP software such as SAP; LIMS; electronic logbooks/forms. Basic computer skills with proficiency in MS Office. Self‑motivated and willing 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. 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. Final, individual compensation will be decided based on demonstrated experience. Benefits Health Coverage: Medical, pharmacy, dental and vision care. Well‑being 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. Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays). 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. On‑site Protocol Roles are classified as site‑essential, site‑by‑design, field‑based or remote‑by‑design. Site‑essential roles require 100% of shifts onsite at the assigned facility. Site‑by‑design roles may be eligible for a hybrid work model with at least 50% onsite. Field‑based and remote‑by‑design roles may require travel to visit customers, patients or business partners. Equal Opportunity Employer Bristol Myers Squibb is an equal opportunity employer and provides reasonable accommodations for applicants with disabilities. Applicants may request accommodations via View email address on click.appcast.io. BMS will consider qualified applicants with arrest and conviction records as required by law. Contact Information Questions about the job posting or application can be directed to View email address on click.appcast.io with the Job Title and Requisition number. Please do not send résumé queries to this email. #J-18808-Ljbffr