- Perform QA reviews of Protocols, Monitor Plans, Data Management Plans, Final Study Reports, statistical analysis reports, intercompany Quality Agreements, and study support documents.
- Perform qualification inspections/audits of selected vendors, laboratories, and clinical study sites
- Maintain and assist in the management of QA systems and QA files for all studies that are assigned to Argenta, MVS QA oversight
- Provide QA guidance to the team in line with Argenta procedures and applicable regulatory standards
- Perform follow up reviews of audit findings to confirm corrective actions have been completed
- Provide oversight and participation in inspections by regulatory agencies and clients
- Maintain QA systems and QA files in an orderly fashion for quick retrieval of documents
- Perform internal and external audits and/or inspections within identified timeframes
- Bachelor's degree, preferably in a scientific discipline or equivalent experience
- Minimum of 5 years' experience in Good Laboratory Practice data management, quality control and/or quality assurance
- Minimum of 5 years' experience in Good Clinical Practice data management, quality control and/or quality assurance
- Experience conducting audits in study protocols in accordance with GLP guidance as well as laboratory GLP setup
- Excellent oral and written communication studies
- Strong analytical thinking and problem solving skills
- Capable of working in a changing environment and under pressure
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Pre-Clinical Senior Quality Assurance Officer - Oakland, United States - Argenta
1 week ago
Description
At Argenta we have a passion for what we do, and we relish a challenge.About us
We are in the animal health business, partnering with our clients in the areas of Research and Development (R&D) and manufacturing to produce pharmaceuticals for both farm and companion animals. Originally founded in 2006 by a New Zealand chemist with an entrepreneurial mindset, Argenta's vision is "Healthier Animals, Sustainably". Our recipe for success has been our uniqueness in our vision and our people. Argenta now has operations across the globe with locations in New Zealand, the United States, Scotland, Germany, and Spain with 600+ employees globally.
Argenta is looking for an experienced Pre-Clinical Senior Quality Assurance Officer to join our Argenta, MVS team.
The Pre-Clinical Senior QA Officer adds value through the following responsibilities:
Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued. At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through strong culture, great benefits, and opportunity for growth.
For more information visit us at
