Quality Control Specialist

Regeneron · Tempel LN

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QualityFull-time$67k–$110kCompany career page

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Role summary

Regeneron seeks a Quality Control Specialist to review analytical test data for Advanced Therapies products, ensuring compliance with cGMP, FDA, EMA, and ICH guidelines. The role involves evaluating laboratory documentation, verifying data integrity, and collaborating with QC teams in a first-shift, Monday-Friday position.

What they're looking for

BS/BA in a scientific field or equivalent education and experience
2 years of related quality control or laboratory experience
Knowledge of cGMP, GDP, FDA, EMA, and ICH regulatory guidelines
Proficiency in analytical methodologies including HPLC, ELISA, SEC, and CE-SDS
Strong written and oral communication skills
Experience in a GMP laboratory setting

What you'll be doing

Review analytical test data for Release, In-Process, and Stability testing in Advanced Therapies
Evaluate method Qualification, Verification, Transfer, and Validation documentation for compliance
Verify data meets ALCOA+ principles and regulatory requirements through detailed review processes
Collaborate with laboratory personnel to resolve documentation errors and support continuous improvement
Maintain communication with QC Analysts and management on compliance and operational matters

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Date posted5 days ago

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