Quality Specialist


Mountain View, CA

What you'll be doing

The QA specialist will be responsible to provide quality and compliance support and administrative service for the effective functioning of the site quality management system. To provide a highly visible profile within all operational and functional areas; acting as a champion for quality and liaise with business sites to drive a quality culture. To be responsible for the effective coordination and control of the company subsidiary document control system of the quality assurance department; and support the issue, distribution, reconciliation and destruction of quality system documentation when required. Under direction and leadership of the QA lead, ensure compliance in meeting GDP and GMP requirements for document control system. Assist with the development and implementation of global procedure and policies. Oversight responsibilities for Site quality staff (e.g. maintain targets, ensure on time delivery). Provide back up support to quality associates as necessary. Actively contribute to QA departmental internal/external audits. To supervise the secure and controlled functioning of documents that requires archiving. To perform a non-technical review and make non-technical corrections on all quality system documentation passing through the document control function of the quality assurance department. To deliver training on good documentation practice as part of the modular GMP training program when appropriate.

What your background should be

Experience of working within a GMP and GCP regulated environment. Computer literate, including knowledge of Excel and Word. A confident communicator with excellent interpersonal skills.

Required Schooling / Training

Who is the client company

The company focused on bringing to market innovative products in specialist areas of medicine to better serve doctors and patients.
If you are interested in this position, send your resume to apply@kochdavis.com