Regeneron Pharmaceuticals Biotech Production Compliance Coordinator in Rensselaer, New York
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 all compliance related administrative tasks necessary for supporting commercial manufacturing operations.
Level to be determined based on qualifications relevant to the role.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Performs administrative tasks in all areas of production as needed in accordance with cGMP standards and in compliance with written procedures.
• Reviews completed batch records and logbooks in accordance with cGMP standards to ensure compliance with written procedure.
• Reviews, edits, and revises controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures.
• Monitors production processes to obtain necessary data in support of investigations and track effectiveness of changes.
• Participates in cross-functional study teams to support and/or author investigations.
• Gathers, trends, and analyzes process related data to drive consistency and timeliness.
• Documents all training.
• Assists with training of new employees.
• Ensures all tasks are performed in a manner consistent with safety standards.
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
• Ability to learn and follow routine procedures independently
• Basic troubleshooting skills
• Identify and communicate continuous improvement ideas
• Ability to work in an every-changing environment
• Build and maintain working relationships
• Goes above and beyond by demonstrating proficiencies with assigned tasks
• Ability to gather, generate, and interpret data
• Participates in projects
Education and Experience:
• Bachelor’s degree, preferably in Life Sciences or a related field, or
• AS/AAS Degree in Biotechnology/Biological Science and 2 years of relevant work experience.
• Relevant biotech or pharmaceutical industry experience may be substituted in lieu of educational 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.
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