Thursday, January 6, 2011

[Outsource:45645] US-MD-Gaithersburg: QA Specialist

US-MD-Gaithersburg: QA Specialist
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99670328_QA_Specialist_.html
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.


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

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