Change Control Specialist

Role Summary

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

Responsibilities

• Craft business plans to independently advance change control initiatives to implement Corrective and Preventative Actions (CAPAs) 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

• Required: Bachelor’s degree in Life Sciences, Engineering or related field
• Required: Relevant experience level determined by role: Associate Specialist – 0-2 years; Specialist – 2+ years; Sr Specialist – 5+ years (level determined by qualifications relevant to the role)
• Required: May substitute proven experience for education requirement
• Preferred: Experience navigating a controlled quality system
• Preferred: Strong attention to detail
• Preferred: Strong technical writing and interpersonal communication skills
• Preferred: Ability to manage multiple assignments and changing priorities
• Preferred: Ability to excel in a fast-paced environment

Education

• Bachelor’s degree in Life Sciences, Engineering or related field