Quality Control Data Reviewer

BioSpace; City of Rensselaer (NY); On-site; USD 34,000 - 53,000; Full time

Job summary

Regeneron is seeking a Data Reviewer to join the Industrial Operations and Product Supply (IOPS) Quality Control Chemistry team in Rensselaer, NY. The role focuses on reviewing data and test records produced by the QC Drug Product team to support product release and stability programs, ensuring data integrity and regulatory compliance.

Location is Rensselaer, New York, with a 2nd shift (Sun-Thurs) from 12:00 PM to 8:30 PM.

Qualifications

• BS/BA in Chemistry, Biology or related field.
• May substitute other relevant experience in lieu of educational requirement.
• Experience with GMP practices and data integrity is preferred.

Responsibilities

• Completing detailed data review for analytical test results generated by QC for compliance with regulatory requirements, internal procedures / work instructions, and specifications
• Documenting in real time all GMP activities performed
• Reviewing release and stability data, trend charts, electronic lab records, lab equipment calibration records, and/ or logbooks
• Participating in training activities
• Participating in inspection and audit activities
• Participating in projects, such as writing and revising procedures or assisting with data integrity assessments for analytical equipment

Skills

Data review

GMP awareness

Documentation

Education

BS/BA in Chemistry, Biology or related field

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently looking for a Data Reviewer to join our Industrial Operations and Product Supply (IOPS) Quality Control Chemistry team to review data and test records produced by the QC Drug Product team to support product release, stability programs, and general lab operations within Quality Control. This role continuously strives to ensure all data is reviewed thoroughly to maintain the highest level of data quality.

When & Where

Location: Rensselaer, New York, United States
Work model: 2nd | Sun-Thurs | 12:00p-08:30p

Discover Your Role

• Completing detailed data review for analytical test results generated by QC for compliance with regulatory requirements, internal procedures / work instructions, and specifications
• Documenting in real time all GMP activities performed
• Reviewing release and stability data, trend charts, electronic lab records, lab equipment calibration records, and/ or logbooks
• Participating in training activities
• Participating in inspection and audit activities
• Participating in projects, such as writing and revising procedures or assisting with data integrity assessments for analytical equipment

This Role Requires

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

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (hourly)

$24.76 - $38.70