QA Specialist (External Filling)

We are currently looking to fill a Quality Assurance Specialist (External Filling) position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

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

Reviewing and approving batch records from external drug product filling sites

Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution

Representing the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communications

Training and/or mentoring junior employees, including providing insights and education on processes and procedures

Providing consultation or advice in alignment with QA policies

Performing activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.), activities may be on the floor or at a desk

Reviewing, editing, or approving Regeneron controlled document

Participating in investigations associated with raw materials or product

Performing status labeling of product

Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement

5% US travel required

This role may be for you if you:

Excel in a quality driven organization

Have an understanding of biologics manufacturing operations

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

Have previous experience in QA and/or Drug Product Filling preferred

To be considered for this role you must hold a Bachelors degree and the following amount of relevant experience for each level:

Associate QA Specialist 2+ years

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.

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

Permanent