QA SPECIALIST TECH TRANSFER

BioSpace
US - New York - Port Chester
October 31, 2024

Job Details

We are hiring a QA Specialist for our Technical Transfer Start Up Team (TTST). As a QA Specialist you will provide QA oversight in the TTST to ensure manufacturing documentation and implementation aligns with Process Transmittals and meet the requirements of Regenerons quality system.

In this role, typical day may include:

Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
Train and/or mentor junior employees, including providing insights and education on processes and procedures.
Provides consultation or advice in alignment with QA policies.
Review, edit, or approve Regeneron controlled documents.
Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials.
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement.
Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (master Batch Records, change control, protocols, reports, qualifications, etc.).
Represent QA in cross-functional team meetings for new product introductions and re-supplies to ensure GMP requirements and current guidelines are followed.
Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues.

This role may be a fit for you if have:

Understanding of biologics manufacturing operations preferred
Good organization skills and attention to detail
Ability to handle multiple assignments and changing priorities
A quality mindset

To be considered for this role you must have a Bachelor's degree in a scientific discipline or related field and the minimum amount of relevant experience for each level:

QA Specialist:
4+ years
Sr. QA Specialist:
6+ 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

Read the full job description and apply online on the recuiter's web-site

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