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Change Control Specialist

2 months ago

Canandaigua, New York, United States Regeneron Pharmaceuticals Full time
Job Summary

We are seeking a highly skilled Change Control Specialist to join our team at Regeneron Pharmaceuticals. As a Change Control Specialist, you will play a critical role in developing and implementing strategic plans to support manufacturing operations.

Key Responsibilities
  • Craft business plans to advance change control initiatives and implement corrective and preventative actions (CAPAs) and process improvements in support of manufacturing operations.
  • Assess proposed change controls to evaluate if they satisfy 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.
  • May manage direct reports.
Requirements
  • Hold a Bachelor's degree in Life Sciences, Engineering or related field.
  • Have a minimum of 0-2 years of relevant experience for the Associate Specialist level, 2+ years for the Specialist level, and 5+ years for the Sr Specialist level.
  • May substitute proven experience for education requirement.
About Regeneron Pharmaceuticals

Regeneron Pharmaceuticals is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.