Change Control Specialist (Technical Operations)

Regeneron Pharmaceuticals • Rensselaer, IN

4d • $67,400 - $110,000 • Onsite

About The Position

We are currently looking to fill a Change Control Specialist position in our growing Technical Operations Compliance team. This position develops strategic plans related to change control and the implementation of robust corrective actions to support manufacturing operations by applying function expertise.

Requirements

• Bachelor’s degree in Life Sciences, Engineering or related field
• Associate Specialist – 0-2 years relevant experience
• Specialist – 2+ years relevant experience
• Sr Specialist – 5+ years relevant experience
• Proven experience may substitute for education requirement.
• Strong attention to detail.
• Strong technical writing and interpersonal communication skills.
• Experience navigating a controlled quality system (preferred but not required).

Nice To Haves

• Excel in a quality driven organization.
• Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills.
• Enjoy working in a fast-paced environment.

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

Benefits

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level