Sr. Specialist, QA Operations
About The Position
The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. The Senior QA Operations Specialist will be responsible for providing oversight of shop floor activities in accordance with regulatory standards and RayzeBio procedures. The role will also support material and batch disposition activities. This position will utilize Quality Assurance expertise to ensure compliance in operations supporting clinical development and GMP commercial operations in accordance with RayzeBio policies, standards, procedures, and global current Good Manufacturing Practices (cGMP). The Senior Specialist provides Quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records, and Material and Lot Disposition. This individual may also interact with the Qualified Person (QP), as needed, to facilitate release of EU doses.
Requirements
- BS/MS degree in a science-related field preferred, including: Biology Biochemistry Chemistry Engineering Related scientific disciplines
- Minimum of 5 years of experience in Quality Assurance and/or Compliance roles within the pharmaceutical industry.
- Experience working in a GMP aseptic manufacturing environment preferred.
- Experience working with the FDA or other regulatory authorities preferred.
- Expertise in GMP, Quality, material disposition, 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 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 operations and compliance supporting clinical and/or commercial manufacturing environments.
- Knowledge of U.S., EU, and global cGMP regulations and guidance.
- Knowledge of and experience working with FDA, EMA, or other regulatory authorities.
- Well-practiced in exercising sound judgment and decision-making.
- Demonstrated prioritization and organizational skills.
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 the Quality disposition process by ensuring 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.
- Use AI tools to enhance individual productivity and quality of work.
- Make sound decisions by exercising judgment within generally defined practices and policies and apply appropriate notification to management as needed.
- Participate, as requested, in response teams for audits and inspections by health authorities.
- Leverage AI tools to enhance individual productivity and quality of work.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Senior
