Quality Assurance Specialist

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual.

Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.

Take your career farther than you thought possible.

The Quality Assurance Specialist will help support operations through quality oversight in a new Radiopharmaceutical facility in Indianapolis, IN.

The Quality Assurance Specialist will be responsible for providing oversight over shop floor activities which includes validation and manufacturing operations.

This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations.

Additional responsibilities may include providing support for corporate activities.

KEY RESPONSIBILITIES :

Build and maintain cross functional relationships to improve processes and resolve issues.

Provide quality oversight on manufacturing and validation activities.

Ensure compliance with applicable procedural and protocol requirements.

Perform real time review of manufacturing records.

Perform periodic walkthroughs to ensure continued compliance with procedures.

Ensure that compliance to the training program is maintained and updated as needed.

EDUCATION / EXPERIENCE / SKILLS

Education and Experience :

BS / MS in a Science related discipline preferred

3-5 years of quality assurance experience

Experience working in a GMP aseptic manufacturing environment preferred

Experience working with FDA or other federal and state regulatory bodies

Skills :

Highly motivated and organized professional with the ability to work independently

Working knowledge of 21 CFR Parts 11, 210, and 211

Very personable with strong communication skills

Excellent professional ethics, integrity, and ability to maintain confidential information

LI-ONSITE

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients’ lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary.

Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.

The occupancy type that you are assigned is determined by the nature and responsibilities of your role :

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.

For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.

For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 .

Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.