Compliance Specialist, External Manufacturing
BioSpace
East Greenbush, NY0–2 yrs57m agovia LinkedIn
About the Role
BioSpace is seeking a Compliance Specialist, External Manufacturing to join the team. This role is responsible for operations support and compliance related activities for the manufacturing of Regeneron products.
Location
East Greenbush, New York, United States
Work Schedule
Monday-Friday, 8am-4:30pm
Key Responsibilities
- Lead and manage change controls, SCARs, SCNs, NPCs, and CAPAs.
- Review and maintain procedures, policies, and other instructional documents with a focus on continuous improvement.
- Maintain knowledge of current good manufacturing practices (cGMPs).
- Support both internal and external inspection and audit readiness activities.
- Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures.
- Maintain required training status on Regeneron specific work instructions and SOPs.
- Continuous process improvement implementation.
Requirements & Tech Stack
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- Proficient in Veeva, Opstrakker, Excel, PowerPoint, Visio, Word.
- Experience working within shared work environments.
Qualifications
- BS/BA in scientific field.
- Knowledge of drug product manufacturing from formulation through the final package.
- Strong interpersonal, written and oral communication skills, with an emphasis on technical writing.
- Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
- Shows resiliency and flexibility in the face of challenges and adversarial situations.
- Understands and listens to team members and stakeholders' needs while supporting productive team environments toward a common objective.
Experience in Collaborating With CMOs/CROs Is Preferred.