Compliance Specialist (Supplier Quality)

Posted 6 Days Ago
Be an Early Applicant
United States of America
58K-124K Annually
5-7 Years Experience
Biotech • Pharmaceutical
The Role
Responsible for maintaining site compliance of operations including manufacturing, quality systems, quality control, and facilities maintenance. Participates in continuous improvement initiatives, interprets compliance requirements, and supports investigations of deviations related to quality. Requires a Bachelor's degree and 2+ years of relevant experience.
Summary Generated by Built In

We are currently looking to fill a Compliance Specialist position supporting Supplier Quality. This position maintains site compliance activities related to supplier audit, new supplier qualifications, supplier life-cycle activities, raw material, packaging component, and single use items in accordance with mandated regulatory requirements and site expectations. Acts as an advisor to the groups supporting Supplier Quality regarding how to maintain compliance. Becomes involved as required to meet schedules or resolve problems. 

 

In this role, a typical day might include the following: 

  • Responsible for ensuring aspects of Quality Compliance for raw material and packaging components and service provides supporting manufacturing, quality systems, quality control, validation, facilities, and materials management. 

  • Supports the investigation and resolution of deviations related to Material & Supplier Quality and Raw Materials 

  • Reviews and Approves Supplier Corrective Action Requests (SCAR) 

  • Participates in regulatory and customer audits 

  • Identify gaps in systems and develop feasible plans for correction 

  • Prepare written reports to management on findings and is integral in the process of developing corrective and preventative actions associated with findings 

  • Actively participate in continuous improvement initiatives 

  • Interprets compliance requirements for incorporation into company systems/procedures 

 

This role may be for you if you: 

  • Experience in raw material, packaging component QC testing, QA batch record review, supplier auditing, or manufacturing operator familiar with the use and function of these materials.  

  • Excel in a quality driven organization 

  • Have supplier quality experience 

  • Are organized and have an attention to detail 

  • Can prioritize multiple assignments and changing priorities 

  • Are able to learn and utilize computerized systems for daily performance of tasks 

 

To be considered for this role you must hold a Bachelor’s degree in a related field and the following amounts of relevant experience for each level: 

  • Quality Compliance Specialist: 2+ years 

  • Sr. Quality Compliance Specialist: 5+ years 

 

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

#REGNQA 

 

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)

$65,100.00 - $124,300.00

The Company
HQ: Rensselaer, New York
15,000 Employees
Hybrid Workplace
Year Founded: 1988

What We Do

At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.

Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media.

An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.

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