Quality Assurance Specialist

Bristol-myers Squibb; Atlanta (GA); On-site; USD 85,000 - 110,000; Full time

Job summary

Bristol-Myers Squibb is seeking a Quality Assurance Specialist to support a new radiopharmaceutical facility in Indianapolis, IN. The role provides quality oversight of shop floor activities, validation and manufacturing operations to ensure GMP and regulatory compliance.

Responsibilities include building cross-functional relationships, reviewing manufacturing records, and maintaining training programs while ensuring adherence to 21 CFR regulations.

Qualifications

• BS/MS in a science-related discipline (preferred).
• 3–5 years of quality assurance experience; GMP aseptic manufacturing experience preferred.
• Experience with FDA or other regulatory bodies.
• Knowledge of 21CFR Parts 11, 210, and 211.
• Highly motivated, organized, able to work independently.

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.
• Maintain and update the training program as needed.

Skills

Quality assurance

GMP aseptic

FDA experience

21 CFR knowledge

Independent worker

Communication skills

Education

BS/MS in science

Job description

The Quality Assurance Specialist supports operations in a new Radiopharmaceutical facility in Indianapolis, IN, by providing quality oversight of shop floor activities, validation, and manufacturing operations to ensure compliance with GMP and regulatory requirements.

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.
• Maintain and update the training program as needed.

Education / Experience / Skills

• BS/MS in a science‑related discipline (preferred).
• 3–5 years of quality assurance experience; experience in a GMP aseptic manufacturing environment preferred.
• Experience working with FDA or other federal and state regulatory bodies.
• Working knowledge of 21CFR Parts 11, 210, and 211.
• Highly motivated, organized, able to work independently.
• Excellent communication skills and professional ethics, integrity, and ability to maintain confidential information.

EEO & Accessibility Statement

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. For additional information, visit careers.bms.com/eeo-accessibility.

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