Quality Assurance Specialist, GMP & Regulatory Ops

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

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.