Sr QA Specialist
Regeneron Pharmaceuticals
Summary
Regeneron is currently looking for a Sr 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.
Job description
Work Schedules
- Wednesday-Sunday, 3rd shift, 10:00 PM - 8:30 AM
In this role, a typical day might include the following
- 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 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
Requirements
- Bachelor's degree
- 6+ years of relevant experience
- May substitute proven experience for education requirement
- Understanding of biologics manufacturing operations
- Ability to work in a cleanroom environment
- Ability to stand for periods of time when performing tasks on the floor
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.