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, Label Operations and Warehouse Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
Shifts: Multiple Shifts Open - Sun-Wed Days - 5:00am-5:30pm
- Wed-Sat Days - 5:00am-5:30pm
- Sun-Wed Nights - 5:00pm-5:30am
- Wed-Sat Nights- 5:00pm-5:30am
Duties / Responsibilities - Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, Label Operations and Supply Chain operations.
- Able to interpret problems and effectively prepare surrounding 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 within Manufacturing Execution System (MES) per 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.
- Perform 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 to ensure compliance with approved procedures.
- Review and provide feedback on documents such as forms, logbooks, and procedures.
- Maintain compliance with assigned learning plan. Provide integration support of newer team members.
- Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
- Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
- Participate in quality and shift meetings.
- Build and maintain relationships with core partner functions and seek collaborative solutions.
- Share data/knowledge within team by acting as a champion for quality-culture.
- For markets requiring an Authorized Person (AP) release to be performed by Summit, act as designated AP performing Certification/Release for Supply in accordance with the PIC/S Guide to GMP (including Annex 16) and any local market requirements e.g. Australian Therapeutic Goods Administration (TGA) requirements, including the Therapeutic Goods Act 1989 and associated GMP principles.
- Perform verification and reconciliation of issued drug product labels.
Reporting RelationshipReports to the Manager, Quality Assurance Shop Floor
Qualifications Specific Knowledge, Skills, Abilities:- Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking.
- Ability to understand, follow, and apply internal policies, procedures, and quality principles.
- Prior experience with quality processes, including but not limited to batch record review, change control, product complaints, deviations, investigations, and CAPA management.
- Ability to assess an unfolding situation, diagnose the problem, 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 with limited information and/or time-constraints.
- Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills.
- Active listening skills to understand diverse working perspectives.
- Contributes to a positive team environment.
- Able to independently make decisions based on data and facts, and recognizes when to escalate
- Seeks opportunities for improvement to quality and operational problems.
- Ability to work within pharmaceutical cleanroom environments.
- Experience with quality management systems for handling 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) such as SAP; laboratory information management systems; or electronic logbooks/forms.
- Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
Education/Experience/Licenses/Certifications:- Bachelor's degree in STEM field. High school diploma or associate's degree with equivalent combination of education and work experience is considered.
- 2+ years of relevant cGMP experience with 1+ years of manufacturing site experience.
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Summit West - NJ - US: $34.92 - $42.32per hour
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including 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 also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
