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QA Validation Specialist

Rensselaer, NY, US

Job Type: Regular Employee
Job Id : 9060BR
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Position Summary

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: The QA Validation Specialist implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• Prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs.
• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
• Reviews, edits and approves change control and SOPs.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Reviews, edits and approves reports, such as, Automation performance evaluation reports, and other reports or documentation submitted to the department.
• Trains/advises less experienced Specialists and Technicians.
• Assesses quality system documentation for completeness and accuracy, and dispositions documentation within Regeneron SOPs.
• Manages projects and prepares status reports.

Experience and Required Skills:
• BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 1 year related experience within the field preferred; may substitute relevant experience for education.
• Ability to comprehend regulatory requirements and technical documentation.
• Ability to work independently and as part of a team.
• Working knowledge of Microsoft Office Suite, FileMakerPro, and Kaye Validator.
• Strong knowledge of cGMPs for pharmaceuticals/biotechnology.
• Excellent written and oral communication skills.

* 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, disability status, protected veteran status, or any other characteristic protected by law.

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