Change Control Specialist

Discover Your Role
- Craft business plans to advance change control initiatives implementing Corrective and Preventative Actions (CAPA’s) and process improvements supporting manufacturing operations.
- Assess proposed change controls to ensure they meet company standards.
- Coordinate and prepare change control documentation defining scope, impact, risk, and regulatory impact.
- Review, edit, and revise controlled documentation in accordance with cGMP standards.
- Coordinate and/or lead cross-functional meetings to drive implementation.
- Provide advice and mentorship to cross-functional teams for successful, GMP-compliant change controls.
- Independently monitor and progress multiple projects; identify, address, and/or raise obstacles in a timely manner.
- Present business-critical and regulatory-impactful change controls to senior leadership.
- Document training; assist with training new employees.

This Role Requires
- BS/BA in Life Sciences, Engineering, or related field (or equivalent education and experience).
- Experience levels:
- Associate Change Control Specialist: 0–2+ years
- Change Control Specialist: 2+ years
- Senior Change Control Specialist: 5+ years
- Level determined based on experience.

Application Instructions
- Apply now.

Salary Range (annually)
- $62,355.00 - $128,700.00