Catalent, Inc. is looking for a Quality Assurance Specialist I to audit laboratory data for adherence to procedures and regulations related to pharmaceuticals, ensuring compliance and supporting the development, manufacturing, and supply of products that help people live better and healthier lives.
Requirements
- Performs laboratory data verification and data audit
- Lead Laboratory facility audits
- Review and approval of certificates of Analysis (CofA), Analytical Result Forms (ARF), Stability Reports and Stability protocols
- Follow GXP (e.g. Good Manufacturing Practices, Good Documentation Practices, etc.) to ensure compliance to applicable FDA, European, etc. Guidelines as necessary to accomplish daily tasks
Responsibilities
- Process Quality Assurance documents submitted by scanning, printing, filing, etc
- Performs laboratory data verification and data audit
- Lead Laboratory facility audits
- Review and approval of certificates of Analysis (CofA), Analytical Result Forms (ARF), Stability Reports and Stability protocols
- Follow GXP (e.g. Good Manufacturing Practices, Good Documentation Practices, etc.) to ensure compliance to applicable FDA, European, etc. Guidelines as necessary to accomplish daily tasks
Other
- Bachelor’s degree in a Science related field with at least four years of related work experience OR Master’s degree in a science related field is required
- Veterinary or Human Pharma Quality Assurance/Quality Control experience strongly preferred
- Exhibits all Catalent Leadership Competencies at the "Individual" level for: Integrity, Delivers Results, Business Acumen, Champions Change, Engages, and Develops
- Responds to problems, issues and opportunities as they are identified
- Collaborates effectively with others; deals with conflict in a positive and constructive manner, communicates information to others who need it; is a ‘team player’
