A well-established Biotech company is looking for a
CMC Product Quality Compliance Coordinator to support their team. This would be a 12-month contract with potential for extension or permanent hire.
Role Details: - 12-month contract (potential for permanent hire)
- $22.00-$24.00
- Monday-Friday 8:00am-4:30pm
This role supports the quality and compliance elements of the life cycle strategy, including ownership of the global regulatory change management implementation plan, end-to-end optimization efforts and overseeing product management activities.On a typical day you will: - Coordinate the evaluation of impact of proposed process changes, deviations and CAPAs on the end-to-end supply chain
- Support the coordination and generation of the annual PQRs and yearly biologic product reports
- Perform activities related to drug supply distribution compliance
- Collaborate cross-functionally to support regulatory release process and inventory review
- Maintain tools, procedures and systems for enhanced tracking of change controls and global regulatory submissions/approvals
- Facilitate the commercial and registration request
What you need to apply: - Associate's degree in a scientific field with 2 years of relevant experience
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