Supervisor,Quality Assurance Specialist Job City of Rensselaer New York USA,Quality Assurance

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Quality Assurance Specialist position. This position performs and leads activities “on the floor” in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

Where & Where:

Location:

Rensselaer, New York, United States
Work model:
Wednesday-Sunday, 3rd shift, 10:00 PM - 8:30 AM

Discover your role:

Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication
Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
Provides consultation or advice in alignment with QA policies through a continuous on the floor presence, working with stakeholders by providing QA guidance to events or questions that may arise
Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.).
Review, edit, or approve Regeneron controlled documents
Review and approve investigations associated with product or processes
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
Supervising direct reports
Participates with employee training to ensure that all requirements are met.
Performs, minimally, monthly performance feedback meetings with direct reports.

This role requires:

BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
Principal QA Specialist: 6+ years of relevant experience
Staff QA Specialist: 8+ years of relevant experience
Experience with sterile drug product manufacturing, fill finish and/or quality control testing
Level will be determined based on experience

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 stand for periods of time when performing tasks on the floor

Gowning and Environment:

Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

If you have any questions,…

Supervisor, Quality Assurance Specialist