Change Control Specialist (Technical Operations)

About the role

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 (CAPA’s) and process improvements in support of manufacturing operations
• Assess sophisticated proposed change controls to evaluate if proposal satisfies company standards
• Cook up and revise controlled documentation in accordance with cGMP standards
• Cook up and revise controlled documentation in accordance with cGMP standards
• Cook up 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

Requirements

Associate Specialist – 0-2 years
Specialist – 2+ years
Sr Specialist – 5+ years

May substitute proven experience for education requirement.

Qualifications

• Hold a Bachelor’s degree in Life Sciences, Engineering or related field
• Manage multiple assignments and changing priorities through robust organizational, planning, and project management skills
• Have a strong attention to detail
• Have strong technical writing and interpersonal communication skills
• Enjoy working in a fast-paced environment
• Have experience navigating a controlled quality system (preferred but not required)

Skills

None specified

Benefits

See details in the job description.

Pay

$67,400.00 - $110,000.00 annually

Schedule

Not specified