Specialist QA Shop Floor

Regulatory Toolkit; Summit (NJ); In loco; USD 47.000 - 58.000; Tempo pieno

Vantaggi offerti da questo lavoro

Global Shutdown

11 paid holidays

Descrizione del lavoro

Bristol Myers Squibb is seeking a Specialist QA Shop Floor in Summit, NJ to provide 24x7 quality oversight across Manufacturing, Quality Control Labs, Label Operations and Warehouse Operations. The role ensures compliance with cGMP and site procedures while partnering with cross-functional teams to maintain product quality and regulatory standards.

The position emphasizes real-time problem solving, deviation management, and documentation within MES/SAP systems.

Competenze

• Bachelor's degree in STEM required; advanced degree a plus.
• 2+ years of relevant cGMP experience with manufacturing site exposure.
• Experience with FDA/EMA regulations in biopharmaceutical manufacturing.

Mansioni

• Provide on-the-floor quality oversight with manufacturing and labs.
• Interpret problems and communicate clearly to management and teams.
• Identify deviations from procedures and escalate as needed.
• Perform and document MES verifications per procedures.
• Observe operations for cleanroom adherence and aseptic techniques.
• Support pre-planned return-to-service quality activities.
• Review batch records for compliance and accuracy.
• Assist with CAPA management and investigations.

Conoscenze

Decision-making

Relationship building

Problem-solving

Analytical thinking

Policy understanding

Quality principles

Quality processes

Communication (written)

Formazione

Bachelor's degree in STEM

2+ years of cgmp experience

Biopharmaceutical manufacturing knowledge

Strumenti

MES

SAP

LIMS

Electronic logbooks

Descrizione del lavoro

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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 Relationship

Reports 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 elevate
• 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 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. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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 [e-mail] 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.

R1606599 : Specialist QA Shop Floor