Quality Control Data Reviewer

Regeneron Pharmaceuticals•Rensselaer, NY
•$25 - $39

About The Position

Regeneron is seeking a QC Data Reviewer to perform data review in support of release activities, stability programs, and laboratory operations within Quality Control. The position follows applicable regulatory agency guidelines to support quality and performance. The schedule is Tuesday through Saturday, 8:00 a.m. to 4:30 p.m. The role includes reviewing analytical test results generated by QC and contract testing laboratories for compliance, correctness, and accuracy. It also supports production, stability studies, laboratory operations, stability reporting, and regulatory updates. The reviewer maintains and updates relevant SOPs and participates in required training activities. A bachelor’s degree in Chemistry, Biology, or a related field is required. Candidates should understand data review and regulatory agency guidelines, analyze data trends effectively, work independently and collaboratively, and communicate well with peer groups. The level will be determined by demonstrated experience. The position’s hourly salary range is $24.76–$38.70; the final offer depends on country, role level, skills, and experience. Regeneron describes its total rewards package as potentially including bonuses or incentives, equity awards, pension or retirement benefits, a 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits; availability depends on country and role. Many roles are required to be performed on-site; candidates should consult their recruiter and hiring manager about expectations for this role and location.

Requirements

  • Bachelor’s degree in Chemistry, Biology, or a related field.
  • Solid understanding of data review and regulatory agency guidelines.
  • Ability to analyze data trends effectively and be results-oriented.
  • Ability to work efficiently independently and with others.
  • Strong communication skills and willingness to build relationships with peer groups.
  • Willingness and ability to work Tuesday through Saturday, 8:00 a.m. to 4:30 p.m.

Responsibilities

  • Review analytical test results generated by QC for compliance with cGMP, internal SOPs, and specifications.
  • Support production, stability studies, and laboratory operations.
  • Review release and stability data, reference-standard trend charts, laboratory equipment calibration records, and logbooks.
  • Review analytical test results from contract testing laboratories for correctness and accuracy.
  • Maintain and update relevant SOPs for data review and reporting.
  • Collaborate with Stability and other groups on stability report writing and regulatory updates.
  • Participate in required training activities.

Benefits

  • Competitive and comprehensive total rewards package, potentially including annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits; offerings depend on country and role.
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