Data Reviewer III

Job Summary

Performs critical in-depth review of all scientific data for Quality Control laboratory documents under minimal supervision.

Area Of Responsibility

With minimal direction from management, this individual :

• Performs critical in-depth review of all scientific data for Quality Control laboratory documents (including, but not limited to review of raw data of in-process, API / Excipients, Finished Products, Stability, Cleaning Verification, Instrument calibration records, Contract laboratory results notebooks, reports, and materials for ANDA submissions) for completeness, integrity and accuracy.
• Demonstrates a thorough knowledge of approved SOP’s, compendia (USP, BP, and EP), ICH, FDA and other regulatory guidances.
• Ensures that all documents are in compliance with cGMPs and the site operating procedures under the direction of QA management.
• Supports systems to ensure the successful completion of Departmental goals and objectives.

Work Conditions :

Physical Requirements :

Travel Estimate

Up to 0 %

Education and Job Qualification

Experience

Disclaimer : The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).