Specialist, Quality Assurance Shop Floor, Cell Therapy

About the role

The Quality Assurance Shop Floor team oversees and partners with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. This position operates on a NIGHT shift, 6 PM – 6 AM, with a Panama schedule (12-hour shift patterns with a 2-2-3 work cycle, including weekends and holidays).

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
• 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
• Support pre-planned return to service plans
• 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

Qualifications

• Specific Knowledge, Skills, Abilities: Action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking
• Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management
• Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work
• Effective communication 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
• 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 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

Benefits

• 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, Unpaid Leave, Summer Hours Flexibility, Leaves of Absence, and an Annual Global Shutdown