Change Control Specialist
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Albany, NY, USA |
| Salary | $58480.4 – $124300 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Entry Level/New Grad, Junior, Mid Level |
Requirements
- Bachelor’s degree in Life Sciences, Engineering or related field
- 0-2 years of relevant experience for Associate Specialist
- 2+ years of relevant experience for Specialist
- 5+ years of relevant experience for Sr Specialist
- Proven experience may substitute for education requirement
Responsibilities
- Craft business plans to independently advance change control initiatives
- Assess sophisticated proposed change controls
- Coordinate and prepare change control documentation
- Review, edit, and revise controlled documentation
- Coordinate and/or lead cross-functional meetings
- Provide advice and mentorship to cross-functional teams
- Independently monitor and progress multiple projects concurrently
- 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
Preferred Qualifications
- Experience navigating a controlled quality system (preferred but not required)
- Excel in a quality driven organization
- Manage multiple assignments and changing priorities
- Strong attention to detail
- Strong technical writing and interpersonal communication skills
- Enjoy working in a fast-paced environment