Quality Assurance Supervisor (CMDO)Germer International • Madison, Wisconsin, United States
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Quality Assurance Supervisor (CMDO)
Germer International
- Madison, Wisconsin, United States
- Madison, Wisconsin, United States
About
* Release raw materials, products (process development batches, engineering batches, clinical trial batches) and GLP test activities to support the CDMO business. * Organize the establishment/maintenance of relevant procedures/documents * Support specification development for CDMO projects. * In collaboration with customers and the CDMO/Regulatory Affairs departments, assist with the preparation of regulatory dossiers supporting CDMO projects. * Provide direction and advice on the application of quality requirements to CDMO projects. * Writes CDMO project related Quality Agreements and verifies the Company is compliant with the approved Quality Agreements (including customer notifications) supporting CDMO projects where necessary. * Responsible for tracking and coordinating responses to all customer communications/inquiries. * Responsible for continuous improvement of cGMP Quality Systems to support CDMO projects in compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements. * Compiles and communicates metrics associated with CDMO projects to management as required. * Participates in audits and addresses audit findings where necessary. * Performs CDMO product release and shipping documentation review/approval.
Job Requirements and Qualifications
* Education Bachelor's Degree
* Experience: * Required: 5+years material release, product development and validation, test method development and validation, approval of investigations, quality agreement and change controls. * Preferred: 10+ years, all of the above plus biologics, drug substances and DMF's.
Languages
- English
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