Quality Control Data Reviewer

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); On-site; USD 34,000 - 53,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Data Reviewer to join the Industrial Operations and Product Supply 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, stability programs, and general lab operations within Quality Control.

The position requires a BS/BA in Chemistry, Biology or a related field, with potential substitution of other relevant experience.

Qualifications

• Requires BS/BA in Chemistry, Biology or related field.
• Experience with data review and documentation in GMP environment preferred.
• Knowledge of regulatory requirements and internal procedures a plus.

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 documentation

Regulatory compliance

Education

BS/BA in Chemistry or Biology

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. This position offers the opportunity to give to a fast‑growing, science‑driven organization making a significant difference to patients worldwide.

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.

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 centres
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• and family support benefits

Salary Range (hourly) $24.76 - $38.70

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.

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.

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.

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