Job Description

Position Summary The Senior Specialist, Quality Assurance Shop Floor role works Monday‑to‑Friday day shift, overseeing quality compliance across manufacturing, QC laboratories, and warehouse operations. The role interacts with cross‑functional teams, implements QA processes using data analytics, record review, and governance forums, and requires effective communication, critical thinking, and continuous learning. Key Responsibilities Provide quality oversight to manufacturing, QC, warehouse, and packout operations. Identify departures from approved procedures and respond to complex issues independently; escalated critical issues to management. Perform and document operational verification per approved procedures. Develop, review, and approve temporary and non‑routine procedures for event response. Observe manufacturing operations and identify departures from clean‑room behaviors and aseptic techniques. Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans. Own actions for departmental programs and propose improvements. Participate in Gemba walks. Communicate and resolve discrepancies independently and escalated as required. Author, review, and approve procedural documents. Maintain compliance with assigned learning plan and provide guidance and training for QA personnel. Serve as quality subject‑matter expert on risk assessments, change controls, and related activities. Lead meetings and represent the function at cross‑functional meetings. Build and maintain strong relationships with partner functions. Prioritize and assign tasks for the team. Establish and maintain key performance indicators and standard work databases aligned with departmental and product supply goals. Function as a project manager, influence others, organize and run meetings. Obtain access to and develop as SME for electronic systems used by Shop Floor Quality (BMSDocs, CELabs, MES, SAP, etc.). Qualifications & Experience Ability to research, understand, interpret, and apply internal SOPs, policies and regulatory guidelines. Proficient computer skills with knowledge of digital tools such as MS Office and ability to learn new software. Ability to interpret data, understand complex problems, and articulate practical solutions. Excellent written and verbal communication; ability to present technical data effectively to varied audiences. Ability to work in a fast‑paced team environment and lead peers through changing priorities. Detail oriented, task focused, meets deadlines and prioritizes work. Negotiation and influence skills to craft mutually beneficial solutions. Ability to motivate and foster a positive team environment. Strong decision‑making ability; think creatively while maintaining compliance and quality. Pioneering mindset and ability to create innovative solutions. Demonstrated experience with quality management systems: records handling (change control, product complaints, deviations, investigations, CAPA). Experience with analytical computer/digital tools (Microsoft Power Automate, Smartsheet, Tableau, etc.). Bachelor’s degree in STEM field preferred; high school diploma or associate’s degree with equivalent experience may be considered. 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceutical or cell therapy manufacturing preferred. Demonstrated experience with GxP electronic systems: QMS, MES, ERP (SAP), laboratory information management systems, electronic logbooks/forms. Working Conditions Physical/mental demands: Able to gown for ISO8 rooms (medical scrubs, safety shoes, safety glasses, gloves, etc.). Equal Employment Opportunity BMS is an equal opportunity employer. We consider qualified applicants with arrest and conviction records, in accordance with applicable laws. Equal Employment Opportunity statement available at careers.bms.com/eeo-accessibility. #J-18808-Ljbffr

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