Associate II, Shop Floor Quality Assurance Cell Therapy

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 Operations.

This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

Shift Available: 6am - 6pm, rotating (panama) schedule including holidays and weekends

Responsibilities

• Provide Quality on-the-floor oversight to Manufacturing/ QC/ Supply Chain Operations & responding to minor issues or escalating to senior members.
• Perform and document operational verification per approved procedures.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Provide quality oversight to maintenance operations and support pre-approved return to service plans.
• 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 or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies and escalate as required.
• Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
• Maintain compliance with assigned learning plan.
• Support internal and external inspections as required.
• Contribute to the assessment of discrepancies and initiation of quality events. * Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/ knowledge within team.
• Build relationships within direct team and partner functions.

Knowledge & Skill

• Ability to understand, follow, and apply approved procedures
• Possess basic computer skills with knowledge of MS Office
• Ability to understand problems and propose practical solutions
• Ability to communicate effectively with cross functional peers and direct management through written and verbal skills
• Ability to work in a fast-paced team environment with changing priorities.
• Detail oriented and task focused, with the ability to meet deadlines and prioritize assigned work.
• Ability to recognize the need for escalation of issues.
• Self-motivated and willingness to learn

Basic Requirement

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 0-2 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

Working Conditions

• Work is largely performed in a modern manufacturing facility where one must be aware of the presence of workplace standards including pressurized liquids gases, steam and hazardous chemicals.
• Use of Personal Protective Equipment (PPE) will be required in some portions of the facility, including appropriate gowning for working in a clean room environment.

Additional information

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

Devens - MA - US: $35.45 - $42.95per 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.

How We Work

• Where 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.

Data Protection

• We will never request payments, financial information, or social security numbers during our application or recruitment process.
• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

• If this posting is missing required information required by local law or incorrect, contact BMS at with the Job Title and Requisition number.
• Do not send application-related inquiries to this email.
• To check your application status, please login to your Candidate Home Account.

R1608212: Associate II, Shop Floor Quality Assurance Cell Therapy