Pharmaceutical Data Review Jobs in Indiana (NOW HIRING)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Control Data Reviewer to join our team, supporting our Rensselaer, NY manufacturing site in an on-site role. In this role, you will help ensure that every raw material entering our manufacturing process meets the regulatory and quality standards our medicines depend on, while collaborating with QC laboratory analysts, Quality Assurance, and Manufacturing teams.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & Where

Location: Rensselaer

Work Schedule: 1st shift, Monday-Friday, 8:00 AM-4:30 PM

Discover your role:

As a QC Data Reviewer with the QC Raw Materials team, a typical day might include the following:

• Execute detailed data review of test results generated by QC to ensure compliance with regulatory requirements, internal procedures, and specifications, supporting routine release, laboratory investigations, material qualification, and/or method validations
• Review electronic lab records, lab equipment calibration records, and logbooks
• Perform laboratory investigations
• Maintain continuous laboratory compliance with cGMP requirements, including laboratory cleanliness, proper documentation, and monitoring reagent expiry
• Participate in audits and training activities
• Contribute to special projects, such as writing and revising laboratory procedures, executing test plans, or supporting method validations

This role requires:

• Have experience with data from multiple chemistry testing procedures and instrumentation (e.g., wet chemistry, HPLC, UPLC, FT-IR spectroscopy, optical or specific rotation, GC, Karl Fischer, titrations)
• Have familiarity with compendial testing procedures (USP, Ph.Eur, JP, BP)
• Possess excellent attention to detail and critical thinking skills
• Have experience with lab-related computer systems such as Empower, Nautilus LIMS, LabWare LIMS, or LabX (preferred)

To be considered for this role, you must be willing and able to work a 1st shift, Monday-Friday, 8:00am-4:30pm schedule. For various levels you must have the following:

• QC Data Reviewer: BS/BA in Life Sciences, or related field, and a minimum of 2+ years related experience; or an equivalent combination of education and experience
• Sr. QC Data Reviewer I: BS/BA in Life Sciences, or related field, and 4+ years of experience; or an equivalent combination of education and experience

Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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. 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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