Change Control Specialist

2 days ago

Troy, New York, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Change Control Specialist to join our team. As a Change Control Specialist, you will be responsible for developing strategic plans related to change control and implementing robust corrective actions 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 a related field
  • Minimum amounts of relevant experience for each level: Associate Specialist (0-2 years), Specialist (2+ years), Sr Specialist (5+ years)
  • May substitute proven experience for education requirement
What We Offer

We have an inclusive and diverse culture that provides comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

Regeneron 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.

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