Sr Specialist, QA Investigations - Summit West, NJ

VetJobs; New Jersey; On-site; USD 75,000 - 102,000; Full time

Job summary

Bristol Myers Squibb is hiring a Senior Specialist, QA Investigations, to provide quality oversight for deviation investigations and related records. The role ensures product quality in compliance with regulations and company guidelines at the Summit Cell Therapy Facility.

The position requires strong data interpretation, investigative writing, and cross-functional collaboration with internal and external stakeholders. On-site schedule supports a Monday–Friday day shift in Summit, NJ.

Qualifications

• Experience in a regulated industry with deviation experience.
• Knowledge of FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.
• Ability to interpret data and assess technical conclusions with quality risk management principles.

Responsibilities

• Review and approve deviation investigations, CAPAs, and effectiveness checks.
• Review technical reports, risk assessments, and deviation system monitoring reports.
• Ensure corrective/preventive actions address root causes and are robust.
• Participate in internal/external inspections and support training content delivery.
• Lead cross-functional meetings and share data across teams.

Skills

Quality investigations

Regulatory knowledge

Analytical thinking

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in STEM

High school diploma/Associate degree with experience

Tools

MS Office

Smartsheets

Electronic systems/databases

Job description

Job Description

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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.

The Senior Specialist, QA Investigations, is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Summit Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines.

Shift Available

Monday - Friday, Onsite Day Shift, 8AM - 5PM

Responsibilities

• Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems.
• Review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.
• Ensure the corrective/ preventive actions and Effectiveness Check plans are robust and adequately addresses the root cause.
• May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
• Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
• Support internal and external inspections as required.
• Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams. Lead meetings and represent function at cross functional meetings. Share data/ knowledge within and across team. Build & maintain strong relationships with partner functions.

Auto req ID

484867BR

Minimum Education Required

High School/GED

Additional Qualifications/Responsibilities

• Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
• Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc. and ability to learn and work with new software applications.
• Ability to interpret data & results, understand problems with few variables and critically assess and provide feedback on proposed CAPA.
• Ability to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles. Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
• Ability to work in a fast-paced team environment and changing priorities.
• Detail oriented and task focused with ability to meet deadlines and support work prioritization.
• Able to work across functional groups and teams to ensure requirements are met.
• Self-motivated and contribute to a positive team environment.
• Confident in making decisions for Minor issues and able to recognize Quality issues and solve problems.
• Curious and ability to think critically to create innovative solutions.

Education/Experience/ Licenses/Certifications

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 4+ years of experience in a regulated industry with 1+ year deviation experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated experience with electronic system and databases.
• Demonstrated experience in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.

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: $83,900 - $101,671

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.

City*

Summit West

State*

New Jersey

Job_Category

Investigations

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Bristol Myers Sqibb BMS

Salary Range

$75,000-$100,000