Senior QA Operations Specialist — Hybrid, GMP

Bristol-Myers Squibb; Indianapolis (IN); Hybrid; USD 82,000 - 100,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan

Paid time off

Job summary

RayzeBio is seeking a Sr. Specialist, QA Operations in Indianapolis to provide quality oversight of shop floor activities in a radiopharmaceutical facility.

The role supports clinical development and GMP commercial operations, reviewing deviations, CAPAs, change controls, and batch records to ensure compliance. Requires a BS/MS in science and at least 5 years in QA/compliance, with GMP aseptic manufacturing and regulatory experience preferred.

Qualifications

• Minimum of 5 years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry.
• Experience working in a GMP aseptic manufacturing environment preferred.
• Experience working with FDA or other regulatory authorities is preferred.

Responsibilities

• Build and maintain cross functional relationships to improve processes and resolve issues.
• Provide quality oversight on manufacturing and validation activities.
• Perform real time review of manufacturing records.
• Perform periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures.
• Provide guidance on the handling of quality and shop floor activities.
• Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications.

Skills

GMP compliance

Quality Assurance

CAPA investigations

Change controls

Documentation review

FDA/EMA knowledge

Education

BS/MS in science

Job description

RayzeBio is seeking a Sr. Specialist, QA Operations in Indianapolis to provide quality oversight of shop floor activities in a radiopharmaceutical facility.

The role supports clinical development and GMP commercial operations, reviewing deviations, CAPAs, change controls, and batch records to ensure compliance. Requires a BS/MS in science and at least 5 years in QA/compliance, with GMP aseptic manufacturing and regulatory experience preferred.