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Change Control Specialist (Internal Fill Finish)

Job Description

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We are currently looking to fill a Change Control Specialist position supporting our new fill finish facility. 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 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).

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 QA Specialist – 0-2 years

  • QA Specialist – 2+ years

  • Sr QA Specialist – 5+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$58,480.40 - $124,300.00