New York

QA Validation Specialist (Drug Product)

Job description          

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: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

Level to be determined based on qualifications relevant to the role Essential Duties and Responsibilities include, but are not limited to, the following:

Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
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 controls, SOPs, reports and other documentation
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
Trains/advises less experienced Specialists.
Manages projects and prepares status reports.
May be required to oversee contingent workers.
Other duties assigned by management. Knowledge Skills & Abilities:
Ability to maintain integrity and honesty at all times
Ability to work independently or as part of a team
Ability to communicate with transparency
Continuously drive to improve processes for improved performance
Demonstrate respectful behavior at all times
Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
Gathers and organizes information
Meets commitments on time
Follows directions; performs well-defined tasks
Effective time management skills
Seeks to identify continuous improvement needs
Education and Experience:

Associate QA Validation Specialist - BS/BA in Engineering, Chemistry, or Life Sciences with 0-2+ years of related experience within the field preferred; may substitute relevant experience for education.
QA Validation Specialist - BS/BA in Engineering, Chemistry, or Life Sciences with 2+ years of related experience within the field preferred; may substitute relevant experience for education.
Sr QA Validation Specialist - BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the field preferred; may substitute relevant experience for education.
Principal QA Validation Specialist - BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field preferred; may substitute relevant experience for education. 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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Career Systems Development Corp. New York jobs

Career Systems Development Corp.

New York jobs

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Career Systems Development Corp. (New York jobs)

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