QC Data Reviewer- Chemistry

Location
Rensselaer, New York, US
Posted
Jul 13, 2018
Ref
13553BR
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.

*This is a 2nd shift, Tuesday-Saturday, 2-10:30pm.

Summary: Performs data review to support raw material, utility programs and lab operation.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Perform detailed data review for analytical test results generated by QC department for compliance with cGMP, internal SOPs and Specifications to support raw material and utility system testing and lab operation. Review trend charts of reference standards, lab equipment calibration records and log-books and other review function as needed.

• Perform detailed data review for analytical test results generated by contract testing labs to assure their correctness and accuracy.

• Maintain and update relevant SOPs for data review and reporting as needed.

• Interact with Quality Assurance and other peer groups for data review problem resolution.

• Complies with all pertinent regulatory agency requirements.

• Participates in required training activities.

Additional duties and responsibilities for level's III and above include, but are not limited to, the following:

• Perform detailed data review for analytical test results generated by contract testing labs to assure their correctness and accuracy, and help them with failure investigation.

• May be responsible for supporting and maintaining a special project for data review.

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:

• Requires BS/BA in Chemistry, Biology or related field. Minimum of 2 years of relevant experience May substitute other relevant experience in lieu of educational requirement.

*Level will be determined by education 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.

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