QC Lab Instrumentation Analyst

Rensselaer, New York
Mar 22, 2018
Required Education
Bachelors Degree
Position Type
Full time
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, 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: Support the Quality Control (QC) department by maintaining their laboratory instrumentation in an operational, qualified state. This entails ensuring both instrument hardware and software qualifications are completed in a timely manner and keeping them in a qualified state.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Coordination of lab equipment installation process including procurement approvals.
• Coordination of activities relating to the qualification, calibration, and maintenance of laboratory equipment and related systems.
• Review / approve qualification and validation documents as needed.
• Scheduling and coordinating all preventive maintenance and repair work performed by outside contractors (includes ensuring vendors are in compliance with site requirements prior to performing equipment related services).
• Ensure qualification, maintenance, and repair activities are communicated to and scheduled with the affected QC functional area and that area management is informed.
• Review of vendor documentation in support of qualification, preventative maintenance, and repair work.
• Ensure the timely submission of work order requests for QC equipment and that scheduled work is completed appropriately.
• Initiate, track, and close work records in BMRAM equipment database as needed.
• Support change control activities impacting QC equipment; provide impact assessments when required.
• Perform investigations of equipment related deviations as needed.
• Participate in Lab Maintenance activities as needed.
• Complies with all pertinent regulatory agency requirements.
• Writes and revises Equipment related SOPs as necessary.

Knowledge and Skills:
• Excellent written and oral communication skills.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Ability to organize and maintain data or information.
• Good time management and attention to detail.
Education and Experience:
• Requires a BS/BA in Chemistry, Life Sciences, Engineering, or related field preferred; will substitute relevant experience for education.

*Title level will be determined based on skills and 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.

Requisition Number: 12643BR