US-MD-Gaithersburg: QA Specialist

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 06-Jan-2011

QA Specialist IV

The QA Specialist supports and provides advice to a number of functional areas including manufacturing, facilities, IT and other Quality departments. Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections. Reviews documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval. Assists the QA Manager to develop the department budget and analyze headcount requirements. May supervise the activities of other QA Specialists.

Quality at the source utilizing on the floor real time review of batch records and addressing product quality issues and possible non-conformances as they occur. Auditing (internal and external - utilizing risk based strategy. Document systems. Change management utilizing a risk based approach. Contribute to product release utilizing systematic process flows. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval. Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections. Assist QA management to develop the department budget and analyze headcount requirements. May travel internationally and represent company during audits.

Education: B.S. in Biology, Chemistry, Engineering or related fields. Specialist position based on education.

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com