QA Specialist (CMO Oversight)

Troy, New York
Jun 11, 2022
Required Education
Bachelors Degree
Position Type

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

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

  • Representing QA both internal to Regeneron and External with partners and Contract Manufacturers 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 and developing and understanding of external partner and manufacturers site procedures

  • Performing activities associated with reading product records for disposition (e.g. manufacturing record, receipt, inspection, document review, shipping, etc.), activities may be on site, at a partner or contract manufacturer or at a desk

  • Reviewing, editing, or approving Regeneron controlled documents

  • Reviewing and approving investigations associated with raw materials, product, laboratory, facilities and materials.

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

This role may be for you if you:

  • Excel in a quality driven organization

  • Have an understanding of aseptic filling and/or packaging 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

To be considered for this role you must hold a Bachelor’s 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.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.