QA Specialist (Drug Product Filling)
Regeneron Pharmaceuticals, Inc.
Rensselaer, New York, United States
Job type: fulltime
Job industry: Other
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: Performs activities 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. Essential Duties and Responsibilities include, but are not limited to, the following: • Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution • Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications • Train and/or mentor junior employees, including providing insights and education on processes and procedures • Provides consultation or advice in alignment with QA policies • Perform 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 • Review, edit, or approve Regeneron controlled documents • Participate in investigations associated with raw materials or product • Perform status labeling of raw materials and product • Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement Knowledge, skills, and abilities: • Understanding of biologics manufacturing operations is preferred • Good organizational skills and attention to detail • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally. • Ability to handle multiple assignments and changing priorities. • Ability to learn and utilize computerized systems for daily performance of tasks • Ability to prioritize, manage multiple tasks, and meet deadlines • Ability to stand for periods of time when performing tasks on the floor. Education and Experience: • Associate level - Requires BS/BA in scientific discipline or related field and minimum 2 years relevant experience. Relevant experience may be substituted for education requirement. • Mid level - Requires BS/BA in scientific discipline or related field and minimum 4 years relevant experience. Relevant experience may be substituted for education requirement. • Senior level - Requires BS/BA in scientific discipline or related field and minimum 6 years relevant experience. Relevant experience may be substituted for education requirement. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.