• , US

Company:  Confidential

Job Title: Supervisor, Quality Control (temp to perm)

Job Number: 78526

Location: , US

Job Description

Looking for a candidate who has extensive experience in drug development, particularly in CMC aspects like quality control, regulatory compliance, stability studies, and in-vitro characterization. Strong data management skills, auditing, statistical analysis, and cGMP compliance are essential. Familiarity with analytical methods, authoring CMC sections for filings, and supporting regulatory reviews is crucial. The role emphasizes managing data integrity for GMP data, ensuring accuracy from technical reports to laboratory records.

Responsibilities

* Extensive experience in drug development, particularly in CMC aspects. * Strong skills in quality control, regulatory compliance, stability studies, and in-vitro characterization. * Proficiency in data management, auditing, statistical analysis, and cGMP compliance. * Familiarity with analytical methods and authoring CMC sections for filings. * Experience supporting regulatory reviews and managing data integrity for GMP data.

Required Skills

* Extensive experience in drug development, particularly in CMC aspects. * Strong skills in quality control, regulatory compliance, stability studies, and in-vitro characterization. * Proficiency in data management, auditing, statistical analysis, and cGMP compliance. * Familiarity with analytical methods and authoring CMC sections for filings. * Experience supporting regulatory reviews and managing data integrity for GMP data.

Application Deadline: 2024-06-03

 

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