Change Control Specialist

About the Role

Develop strategic plans related to change control and the implementation of robust corrective actions to support manufacturing operations by applying function expertise. Current departments with openings include Bulk Drug Substance Manufacturing, Technical Operations, and Fill/Finish Manufacturing.

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

Qualifications

BS/BA in Life Sciences, Engineering, or related field; or equivalent combination of education and experience, with the following amount of relevant experience for each level:

• Associate Change Control Specialist: 0-2+ years
• Change Control Specialist: 2+ years
• Senior Change Control Specialist: 5+ years

Level will be determined based on experience.

Schedule

Monday-Friday, 8am-4:30pm

Location

Rensselaer, New York, United States