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nxtgen search: Qc project manager

Nxtgen Search

This is a Full-time position in Torrance, CA posted March 23, 2020.

JOB SUMMARY The Quality Control Project Manager fulfills a critical role in cGMP operations and plays a crucial role in active pharmaceutical ingredients (APIs) manufacturing operations.This individual will act as a project manager in executing special projects such as validation and qualification studies, method transfers, API release, stability study designs and other department related technical studies and continuous improvement projects.

The Quality Control Project Manager should have full knowledge in compliance, deviations, investigations, Out-of-Specifications (OOSs) and implement corrective action and preventive actions (CAPAs).

Job Duties: Write protocols and final reports, standard operating procedures (SOPs), and reports in compliance with current industry standards and regulatory requirements Ensure the quality and integrity of data generated for each project by verifying documentation is complete and accurate, and all data documentation follows SOP requirements Design and implement study plans and protocols to complete required assignments, and draw conclusions based on data generated Support, implement and ensure compliance of all QC department policies and activities Ensure compliance with all regulatory agencies through documentation, audits and corrective actions Perform investigations related to QC with respect to data analysis, trend charts preparation, as requested by the QC Department Review API release test data for completeness and accuracy as necessary Provides timely responses to internal and external inquiries Support and assist in internal/external inspections and audits Contribute to GMP systems improvements Apply knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) on a daily basis Provide guidance for the review and disposition of deviations; investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent reoccurrences Coordinates API release and stability studies as required Lead weekly meetings providing timely updates on the status of projects with QC management Provide the necessary drive and supervision for the department to meet the required timelines for method validation studies, technical studies, and other department projects Qualifications: Bachelor’s Degree with a minimum of 7 years of industry experience in a GMP/GLP environment Strong knowledge of cGMP/GLP/GDP, USP/NF, ICH guidelines and FDA regulations In-depth knowledge and understanding of Analytical Chemistry, including USP compendial testing Excellent written and oral communication skills