Job Description
The Associate Compliance Specialist-External Manufacturing is a member of the External Manufacturing Team and is responsible for operations support and compliance related activities for the manufacture of Regeneron products. This is a temporary 12-month contract position.
A typical day might include, but is not limited to, the following:
- Leading and managing deviation investigations, CAPAs and change controls
- Reviewing and maintaining procedures, policies and other instructional documents with a focus on continuous improvement
- Generating and tracking performance metrics
- Maintaining good knowledge of current good manufacturing practices (cGMPs)
- Completing periodic reviews of External Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures
- Traveling to contract manufacturers or business partners, as the need arises (25% or less)
- Maintaining training status on Regeneron specific work instructions and SOPs
- Assisting in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at External Manufacturing contract manufacturers
- Implementing continuous process improvements
- May require supervisory responsibilities
This role might be for you if:
- You have a solid understanding of External Manufacturing from formulation through the final package
- You have an understanding of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations
- You are proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments
- You exhibit confidence and have strong interpersonal, written and oral communication skills for providing team updates
- You can show resilience and flexibility in the face of challenges and adversarial situations
- You have experience in collaborating with CMOs/CROs
To be considered for this position you must hold a BS/BA in a scientific discipline and 0-2 years' experience is required.
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