Change Control Specialist
Regeneron
Full-time
Remote friendly (Rensselaer, NY)
United States
Operations
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Role Summary
Change Control Specialist responsible for developing strategic plans related to change control and implementing robust corrective actions to support manufacturing operations by applying function expertise.
Responsibilities
- Craft business plans to independently advances change control initiatives to implement Corrective and Preventative Actions (CAPA’s) and process improvements in support of manufacturing operations
- Assess sophisticated proposed change controls to evaluate if proposal satisfies company standards
- Coordinate and prepare change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change
- Review, edit, and revise controlled documentation in accordance with cGMP standards
- Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation
- Provide advice and mentorship to cross-functional teams to enable successful and GMP compliant change controls
- Independently monitor and progress multiple projects concurrently – identifying, addressing, and/or raising potential obstacles in a timely manner
- Present business critical and regulatory impactful change controls to senior leadership
- Document all training
- Assist with the training of new employees
- May manage direct reports
Qualifications
- Associate Specialist – 0-2 years
- Specialist – 2+ years
- Sr Specialist – 5+ years
Skills
- Excel in a quality driven organization
- Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills
- Have a strong attention to detail
- Have strong technical writing and interpersonal communication skills
- Enjoy working in a fast-paced environment
- Experience navigating a controlled quality system (preferred but not required)
Education
- Bachelor’s degree in Life Sciences, Engineering or related field
Additional Requirements
- May substitute proven experience for education requirement