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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
SUMMARY: Determines disposition of final product and ensures compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
* Prepares appropriate documentation and executes release of acceptable product lots and vendor materials
* Reviews completed manufacturing, filling, and labeling records, and analytical data for conformance to regulations, SOPs,
specifications and other applicable acceptance criteria
* Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions
* Reviews, edits, and approves change control and SOPs
* Reviews, edits, and approves new and revised master manufacturing records
* Reviews, edits, and approves validation protocols and executed protocol reports
* Audits production and other departments for quality system effectiveness
* Performs hands-on monitoring of production and non-production activities and notifies area and Quality Management of any observed non-compliance
*Hours for this position may include weekend and or evening hours*
EXPERIENCE AND REQUIRED SKILLS:
* Requires BS/BA in scientific discipline or related field and minimum 2 years relevant experience. Will substitute relevant experience for educational requirement
*Level will be determined based on skills and related experience*
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.