The role will support the company's quality and regulatory systems in compliance with industry best practices.
- Perform Quality Assurance activities to ensure compliance with internal processes and procedures in support of GMP and GCP procedures.
- Review documentation for release of combination products including manufacturing batch records
- Coordinate the review, approval, issue and maintenance of QA controlled documents and records including SOPs, Templates, and Technical Reports.
- Process internal deviations, investigations, CAPAs, and change controls.
Skills and Abilities:
- Ability to coordinate and prioritize all areas of responsibility in a fast-paced environment
- Team oriented and adaptable with solution-oriented nature
- Excellent written and oral communication skills
- Exceptional organizational and time management skills with the ability to confidently multi-task