Change Control Specialist

Regeneron; City of Rensselaer (NY); On-site; USD 58,000 - 125,000; Full time

Job summary

Regeneron is seeking a Change Control Specialist to support manufacturing operations in Rensselaer, NY. The ideal candidate will develop and implement strategic change control initiatives, manage documentation, and mentor cross-functional teams. A Bachelor's in Life Sciences or Engineering and relevant experience are essential. Joining Regeneron offers a chance to be part of a diverse and inclusive culture with comprehensive benefits.

Benefits

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Qualifications

• Bachelor's degree required, preferably in Life Sciences or Engineering.
• 0-2 years for Associate Specialist, 2+ years for Specialist, 5+ years for Sr Specialist
• Proven experience may substitute for education requirement.

Responsibilities

• Develop strategic plans and implement Corrective and Preventative Actions (CAPAs).
• Coordinate and prepare change control documentation, assessing risks.
• Lead cross-functional meetings to ensure compliance and successful implementation.

Skills

Attention to detail

Technical writing

Interpersonal communication

Organizational skills

Project management

Education

Bachelor’s degree in Life Sciences

Bachelor’s degree in Engineering

Job description

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We are currently looking to fill multiple Change Control Specialist positions. These positions develop strategic plans related to change control and the implementation of robust corrective actions to support manufacturing operations by applying function expertise.

Current Department With Openings

• Manufacturing
  
  

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 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
  
  

This Role Might Be For You If You

• Excel in a quality driven organization.
• Can 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).
  
  

Role

To be considered for this role you must hold a Bachelor’s degree in Life Sciences, Engineering or related field and following 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. Level is determined based on qualifications relevant to the role.

#REGNEC

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$58,480.40 - $124,300.00

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology

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