Specialist QA Shop Floor

Bristol Myers Squibb • Summit, NJ

5d • $35 - $42 • Onsite

About The Position

The Quality Assurance Shop Floor team provides 24x7 quality collaboration and oversight for site operations, including Manufacturing, Quality Control Laboratories, Label Operations, and Warehouse Operations. The Specialist QA Shop Floor oversees and partners with operational areas to ensure compliance with Bristol Myers Squibb policies, standards, procedures, and global cGMP requirements. This role is scheduled Wednesday through Saturday nights, 5:00 p.m. to 5:30 a.m., and reports to the Manager, Quality Assurance Shop Floor.

Requirements

• Action-oriented, with proficiency in decision-making, relationship-building, problem-solving, and analytical thinking.
• Ability to understand, follow, and apply internal policies, procedures, and quality principles.
• Prior experience with quality processes, including batch record review, change control, product complaints, deviations, investigations, and CAPA management.
• Ability to assess unfolding situations, diagnose problems, and propose practical solutions.
• Detail-oriented and task-focused, with the ability to meet deadlines and prioritize assigned work.
• Ability to work in a fast-paced team environment with changing priorities and limited information or time.
• Effective technical writing and verbal communication with cross-functional peers and multiple levels of management.
• Active listening skills and ability to understand diverse working perspectives.
• Ability to contribute to a positive team environment.
• Ability to make independent decisions based on data and facts and recognize when to escalate.
• Ability to identify opportunities to improve quality and operational processes.
• Ability to work in pharmaceutical cleanroom environments.
• Experience using quality management systems to handle 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 systems such as SAP, laboratory information management systems, or electronic logbooks and forms.
• Proficiency with digital tools such as Microsoft Power Automate, Smartsheet, or Tableau.
• Bachelor's degree in a STEM field, or a high school diploma or associate degree with an equivalent combination of education and work experience.
• At least 2 years of relevant cGMP experience, including at least 1 year of manufacturing site experience.
• Experience with FDA and EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Responsibilities

• Provide routine on-the-floor quality oversight and triage unexpected events in Manufacturing, Quality Labs, Label Operations, and Supply Chain operations.
• Interpret problems and communicate clearly, briefly, and accurately with management and relevant teams.
• Identify departures from approved procedures, respond independently to issues, and escalate complex issues to senior team members.
• Perform and document operational verification in the Manufacturing Execution System (MES) in accordance with approved procedures.
• Observe manufacturing operations and identify departures from procedures, cleanroom behaviors, and aseptic techniques.
• Provide quality oversight for pre-planned return-to-service plans.
• Conduct area walkthroughs to identify quality issues, propose remediations, and support implementation plans with area owners.
• Identify and propose improvements to programs, procedures, and practices.
• Review manufacturing batch records for compliance with approved procedures.
• Review and provide feedback on documents such as forms, logbooks, and procedures.
• Maintain compliance with the assigned learning plan and provide integration support to newer team members.
• Independently approve deviation records in the quality management system, applying quality risk management principles and process knowledge.
• Review and interpret technical conclusions in records and investigations and provide constructive feedback.
• Participate in quality and shift meetings.
• Build and maintain relationships with core partner functions and seek collaborative solutions.
• Share data and knowledge with the team and champion a quality culture.
• For markets requiring Summit to perform Authorized Person (AP) release, act as the designated AP for Certification/Release for Supply in accordance with the PIC/S Guide to GMP, including Annex 16, and applicable local requirements, including Australian TGA requirements and the Therapeutic Goods Act 1989.
• Verify and reconcile issued drug product labels.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• For non-exempt employees, 160 hours of paid vacation annually for new hires, subject to manager approval.
• 11 paid company holidays and 3 optional holidays for non-exempt employees.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for additional discretionary cash incentives and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level