Quality Control Data Reviewer

Regeneron; United States; On-site; USD 34,000 - 54,000; Full time

Job summary

Regeneron in Rensselaer, NY is seeking a Quality Control Data Reviewer to perform detailed review of analytical results for release, stability programs, and lab operations, ensuring compliance with cGMP and internal SOPs.

The role collaborates with other QA groups, maintains SOPs, and participates in training. On-site work with a science-first culture, contributing directly to medicines that reach patients.

Qualifications

• BS/BA in Chemistry, Biology, or related field required.
• GMP experience preferred.
• Familiarity with LIMS systems.

Responsibilities

• Execute detailed data review of analytical test results for cGMP compliance.
• Support production, stability studies, and lab operations through timely data review.
• Review release and stability data, calibration records, and logbooks.
• Review data from contract testing labs to confirm accuracy.
• Maintain and update SOPs for data review and reporting.
• Collaborate with Stability and other groups for reports and regulatory updates.
• Identify and escalate data discrepancies to appropriate teams.
• Participate in all required training activities.

Skills

Attention to detail

Regulatory knowledge

Team collaboration

Education

BS/BA in Chemistry or Biology

Tools

LIMS

Job description

Regeneron is looking for a Quality Control Data Reviewer to perform data review to support release, stability programs, and lab operation within Quality Control. This role continuously strives to follow all pertinent regulatory agency guidelines to drive performance. We offer a collaborative, science-first culture and the chance to see your work translate directly into medicines that reach patients.

When & Where:

Monday-Friday, 8:00am-4:30pm
Location: Rensselaer, New York, United States

Discover your role:

• Execute detailed data review of analytical test results generated by QC for compliance with cGMP, internal SOPs, and specifications
• Support production, stability studies, and lab operations through timely, accurate data review
• Review release and stability data, reference standard trend charts, lab equipment calibration records, and logbooks
• Perform detailed data review of analytical test results generated by contract testing labs to confirm correctness and accuracy
• Maintain and update relevant SOPs for data review and reporting
• Collaborate with Stability and other groups to support stability report writing and regulatory updates
• Identify and escal… data discrepancies or trends to the appropriate teams for timely resolution
• Participate in all required training activities

This role requires:

• A BS/BA in Chemistry, Biology, or related field.
• Level will be determined by demonstrated experience.
• Prior experience in a cGMP-regulated laboratory or manufacturing environment
• Familiarity with electronic laboratory data systems (e.g., LIMS)

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.

Salary Range (hourly)
$24.76 - $38.70

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.

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

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 on‑site.

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.