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About the position
The Associate, Quality Control Data Review position at RayzeBio, a Bristol Myers Squibb company, is focused on ensuring the accuracy and compliance of Quality Control data related to targeted alpha therapy radiopharmaceuticals. The role involves reviewing data, conducting investigations, and documenting findings to support the development and commercialization of innovative cancer treatments. This position requires a detail-oriented individual with a strong background in laboratory practices and regulatory compliance in the pharmaceutical industry.
Responsibilities
- Review Quality Control data for accuracy, completeness, and compliance with established procedures and regulatory requirements.
- Ensure Quality Control data is reviewed in a timely manner.
- Conduct periodic review and updates of Quality Control Standard Operating Procedures, as necessary.
- Lead and conduct in-depth investigations for out of specification results and other quality issues in the quality control laboratory.
- Document findings of investigations and propose corrective actions and training to prevent repeat events.
- Ensure data integrity throughout data review and investigations as required.
- Proactively identify opportunities for improvements to both investigations and the data review processes.
- Perform other duties as assigned by management.
Requirements
- BS in Chemistry, Biology, Science, or relevant field with five to seven years of experience in pharmaceutical or other cGMP experience.
- Thorough understanding of cGMP regulations, ICH guidelines, FDA and other regulatory process investigation processes.
- Direct experience with cGMP technical writing is required.
- Experience with injectable pharmaceuticals or radiopharmaceuticals strongly preferred.
- Experience tracking maintenance of laboratory equipment preferred.
Nice-to-haves
- Advanced degrees may be acceptable with less experience.
- Ability to multi-task and prioritize work based on multiple workflows.
- Strong analytical and problem-solving skills.
- Ability to work well and communicate effectively with multiple stakeholders.
- Strong written and oral communication skills.
Benefits
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Work-life balance and flexibility in the work environment.
