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Sr. QC Manager

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POST DATE 8/12/2016
END DATE 11/6/2016

Lab Support, A Division Of On Assignment Tustin, CA

Location
Tustin, CA
AJE Ref #
575860818
Job Classification
Full Time
Job Type
Regular
Company Ref #
360037
Experience
Entry Level (0 - 2 years)

JOB DESCRIPTION

Review analytical data, drug substance/product release documentation and stability time point data.
Perform stability trending per ICH guidelines as requested by clients.
Interact with internal customers from cross-functional groups.
Assign personnel to perform investigations related to OOS.
Initiation and revision of SOPs
Supervise and train QC Analysts and Supervisors
Prepare for client and regulatory audits.
Reviewing batch release documents for GMP certification associated with product release
Ensuring compliance with regulations
Prepare certificates of analysis and stability summary reports.