Job Description
We are currently looking to fill a Change Control Specialist position in our growing Technical Operations Compliance team. This position develops strategic plans related to change control and the implementation of robust corrective actions to support manufacturing operations by applying function expertise.
In this role, a typical day might include the following:
+ Craft business plans to independently advances 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
+ 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 de...
In this role, a typical day might include the following:
+ Craft business plans to independently advances 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
+ 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 de...