Quality Control Data Reviewer

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 52,000 - 81,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension/retirement

401(k) company match

Health & wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, Inc. (USA) is seeking a Quality Control Data Reviewer to perform detailed data review of analytical results to support release, stability programs, and lab operations in a cGMP environment.

The role is on-site in Rensselaer, NY, with a Monday–Friday schedule, 8:00am–4:30pm. A BS/BA in Chemistry or Biology and experience in regulated labs are required; familiarity with LIMS is preferred.

Qualifications

• 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).

Responsibilities

• Execute detailed data review of QC analytical results for cGMP compliance.
• Support production, stability studies, and lab operations via timely data review.
• Review release/stability data, reference trends, calibration records, and logbooks.
• Review data from contract labs to confirm correctness.
• Maintain and update SOPs for data review and reporting.
• Collaborate with Stability and other groups on stability reports.
• Identify data discrepancies and escalate to teams for resolution.
• Participate in required training.

Skills

Data review

cGMP

LIMS

SOPs

QA collaboration

Education

BS/BA in Chemistry, Biology, or related field

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 escape 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)

Does this sound like you?

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
• 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.

If you have any questions, please speak with your recruiter.

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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.