Change Control Specialist

Role Summary

Change Control Specialist responsible for developing strategic plans related to change control and implementing robust corrective actions to support manufacturing operations through 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 ‚Äì 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

• To be considered for this role you must hold a Bachelor‚Äôs degree in Life Sciences, Engineering or related field and following minimum amounts of relevant experience for each level:
  • Associate Specialist ‚Äì 0-2 years
  • Specialist ‚Äì 2+ years
  • Sr Specialist ‚Äì 5+ years
• May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Skills

• Excel in a quality driven organization
• Ability to manage multiple assignments and changing priorities through organizational, planning, and project management skills
• Strong attention to detail
• Strong technical writing and interpersonal communication skills
• Ability to work in a fast-paced environment
• Experience navigating a controlled quality system (preferred but not required)