QA Specialist II-IV
Job Posting Title: QA Specialist II-IV
Person Type: Regular
Posting Category QA, QC & Quality Auditing
Job Summary And Essential Functions
If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.
Regeneron is currently seeking a talented and motivated QA Specialist to join our Quality Assurance department. The ideal candidate determines disposition of final product and ensures compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
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 at CMO's and notifies area and Quality Management of any observed non-compliance.
May oversee work of more entry-level employees.
35% Travel Required
Knowledge And Skills
Solid knowledge of cGMP and other regulatory requirements associated with biotech/pharm industry.
Excellent interpersonal, written, and oral communication skills.
Demonstrated problem-solving skills.
Ability to manage multiple tasks, and meet deadlines.
Working knowledge of word processing, spreadsheet, and database management software.
Experience And Required Skills
BS/BA in scientific discipline or related field and minimum 3 years relevant experience preferred. May substitute relevant industry experience for educational requirement.
Must have Validation experience, preferably in the areas of filling, labeling and packaging.
We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.
Disclaimer: Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex -www.candex.com
ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.