Senior Specialist QA Operations

Senior Specialist, QA Operations

Company:
Rayze Bio, a Bristol Myers Squibb company, located in Indianapolis, IN. This role focuses on quality oversight in a radiopharmaceutical facility and supports clinical development and GMP commercial operations.

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. Take your career farther than you thought possible.

• 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, including all related deviations.
• Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation.
• Identify and report discrepancies from required work practices or procedures to management.
• Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Participate as requested in the response team for audits and inspections by health authorities.

• BS/MS degree in a science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred.
• Minimum of 5 years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry or a related industry.
• Experience working in a GMP aseptic manufacturing environment preferred.
• Experience working with FDA or other regulatory authorities is preferred.

• Expertise in GMP, Quality, material and product disposition.
• Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles.
• Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management.
• Team player who can work independently to achieve objectives in a fast-paced environment.
• Excellent verbal and written communication skills.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.
• Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required include close vision and distance vision.

This position requires working in an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.

The noise level in the work environment is usually moderate. This position may require work outside of normal working hours or on weekends.

Indianapolis - Rayze Bio - IN: $82,236 - $99,650

The starting compensation range(s) for this role are listed above for a full-time employee basis. Additional incentive cash and stock opportunities (based on eligibility) may be…