Senior Specialist, QA Operations
Bristol Myers Squibb
2 months ago
On-site
Indianapolis, IN
Operations
Summary
The Senior Specialist, QA Operations will provide quality oversight in a radiopharmaceutical facility in Indianapolis, IN, including oversight of shop floor activities and material/batch disposition in accordance with regulatory standards, RayzeBio procedures, policies, and global cGMP.
Job 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.
- Conduct periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance.
- Provide guidance on handling quality and shop floor activities.
- Support the Quality disposition process by ensuring required documents are completed and compiled against approved procedures/specifications, including related deviations.
- Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other GMP documentation.
- Identify and report discrepancies from required work practices or procedures to management.
- Use AI tools to enhance individual productivity and quality of work.
- Make sound decisions using judgment within defined practices/policies and notify management as appropriate.
- Participate (as requested) in response team for audits and inspections by health authorities.
Education and Experience (Preferred/Required)
- BS/MS in a science-related field (biology, biochemistry, chemistry, engineering, or related) preferred.
- Minimum 5 years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry (required).
- Experience in GMP aseptic manufacturing environment preferred.
- Experience working with FDA or other regulatory authorities preferred.
Skills and Qualifications (Required/Preferred)
- Expertise in GMP, Quality, and material/product disposition.
- Ability to author and critically review investigations; interpret results; generate technical conclusions consistent with Quality risk management principles.
- Detail-oriented with problem-solving/decision-making abilities with moderate oversight.
- Team player able to work independently in a fast-paced environment.
- Excellent verbal and written communication skills.
- Strong background in quality assurance operations and clinical/commercial manufacturing compliance desired.
- Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
- Knowledge and proven experience with FDA, EMA, or other regulatory authorities.
- Sound judgment, prioritization, and organization skills.
Benefits (as stated)
- Health Coverage: medical, pharmacy, dental, vision.
- Wellbeing Support (e.g., BMS Well-Being Account, Employee Assistance Programs).
- Financial Well-being and Protection (e.g., 401(k), disability, life insurance, etc.).
- Work-life: Paid Time Off, including flexible time off/paid vacation and paid national holidays (per employment category/eligibility).
- Additional time off options based on eligibility (e.g., paid sick time, volunteer days, leaves of absence, Global Shutdown).
Application Instructions
- If you do not perfectly match the resume, you are encouraged to apply anyway.
The Senior Specialist, QA Operations will provide quality oversight in a radiopharmaceutical facility in Indianapolis, IN, including oversight of shop floor activities and material/batch disposition in accordance with regulatory standards, RayzeBio procedures, policies, and global cGMP.
Job 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.
- Conduct periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance.
- Provide guidance on handling quality and shop floor activities.
- Support the Quality disposition process by ensuring required documents are completed and compiled against approved procedures/specifications, including related deviations.
- Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other GMP documentation.
- Identify and report discrepancies from required work practices or procedures to management.
- Use AI tools to enhance individual productivity and quality of work.
- Make sound decisions using judgment within defined practices/policies and notify management as appropriate.
- Participate (as requested) in response team for audits and inspections by health authorities.
Education and Experience (Preferred/Required)
- BS/MS in a science-related field (biology, biochemistry, chemistry, engineering, or related) preferred.
- Minimum 5 years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry (required).
- Experience in GMP aseptic manufacturing environment preferred.
- Experience working with FDA or other regulatory authorities preferred.
Skills and Qualifications (Required/Preferred)
- Expertise in GMP, Quality, and material/product disposition.
- Ability to author and critically review investigations; interpret results; generate technical conclusions consistent with Quality risk management principles.
- Detail-oriented with problem-solving/decision-making abilities with moderate oversight.
- Team player able to work independently in a fast-paced environment.
- Excellent verbal and written communication skills.
- Strong background in quality assurance operations and clinical/commercial manufacturing compliance desired.
- Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
- Knowledge and proven experience with FDA, EMA, or other regulatory authorities.
- Sound judgment, prioritization, and organization skills.
Benefits (as stated)
- Health Coverage: medical, pharmacy, dental, vision.
- Wellbeing Support (e.g., BMS Well-Being Account, Employee Assistance Programs).
- Financial Well-being and Protection (e.g., 401(k), disability, life insurance, etc.).
- Work-life: Paid Time Off, including flexible time off/paid vacation and paid national holidays (per employment category/eligibility).
- Additional time off options based on eligibility (e.g., paid sick time, volunteer days, leaves of absence, Global Shutdown).
Application Instructions
- If you do not perfectly match the resume, you are encouraged to apply anyway.