Biotech Production Compliance Coordinator (Entry Level/New Grad)

Summary: Performs tasks related to change management and the implementation of robust corrective actions to support manufacturing operations.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Independently advances change management initiatives to implement Corrective and Preventative Actions (CAPA’s) and process improvements in support of manufacturing operations.

• Coordinates and prepares change management documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change.

• Reviews, edits, and revises controlled documentation in accordance with cGMP standards.

• Coordinates and/or leads cross-functional meetings with multiple departments to drive change control implementation.

• Independently monitors and progresses multiple projects concurrently – identifying, addressing, and/or raising potential obstacles in a timely manner.

• Presents business critical and regulatory impactful change controls to senior leadership.

• Documents all training.

• Assists with the training of new employees.

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).

Education and Experience:
Level II: Bachelor’s degree, preferably in Life Sciences or a related field, or
AS/AAS Degree in Biotechnology/Biological Science and 0-2 years of relevant work experience
Level III: Requires BS/BA in Life Sciences, or related field and 2 years of
relevant experience or equivalent combination of education and experience
Sr Level: Requires BS/BA in Life Sciences, or related field and 5 years of
relevant experience or equivalent combination of education and experience
 

Title level is based on education and experience 

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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 (hourly)

$20.27 - $41.88