Change Control Specialist (Technical Operations)

About the role

Craft business plans to independently advance change control initiatives to implement Corrective and Preventative Actions (CAPAs) and process improvements in support of manufacturing operations.

Responsibilities

• Audit 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
• Cook up 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
• 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

Requirements

• Experience navigating a controlled quality system (preferred but not required)

Qualifications

• Bachelor's Degree in Life Sciences, Engineering or related field
• Associate Specialist: 0-2 years of relevant experience
• Specialist: 2+ years of relevant experience
• Sr Specialist: 5+ years of relevant experience

Skills

• Excel in a quality driven organization
• Manage multiple assignments and changing priorities through robust organizational, planning, and project management skills
• Strong attention to detail
• Strong technical writing and interpersonal communication skills
• Enjoy working in a fast-paced environment

Benefits

See above.

Pay

$67,400.00 - $110,000.00 annually

Schedule

Full time