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US-MD-Gaithersburg: QA Specialist
To see other opportunities,
please visit http://sqa.fyicenter.com
Date: 06-Feb-2009
QA Specialist IV
Knowledge:
Complete understanding and wide application of technical principles, theories, and concepts in the field. General knowledge of other related disciplines.
Problem Solving:
Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organizational objectives.
Discretion / Latitude:
Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy, in meeting objectives.
Impact:
Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
Liaison:
Frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
Position Requirements Typical Experience:
5-7 years experience
Computer Skills:
Outlook, Deviation, CR Tracking Software, EDMS, Explorer, Excel, Word, MS Office
Performance Requirements
Essential Job Functions:
A. Responsible for auditing (internal and external-utilizing a risk based strategy. Change management utilizing a risk based strategy.
B. Operational excellence utilizing tools such as FMEA, DMAIC and root cause analysis.
C. Quality at the source utilizing on the floor real time review and investigations. The QA Specialist supports and provides advice to a number of functional areas including manufacturing, facilities, IT, and other Quality departments.
D. Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections.
E. 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.
F. Assists the QA Manager to develop the department budget, and analyze headcount requirements. May supervise the activities of other QA Specialists.
Additional Job Functions:
1. Utilizes quality assurance system in compliance with current good manufacturing practice regulations.
2. Administers the change control and Deviation and corrective action systems for assigned products and quality systems.
3. Maintains database; generates standard and ad hoc reports.
4. Manages workflows to assure timely supply of commercial product.
5. Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents.
6. Investigates and assesses the impact of minor and major deviations that may occur during manufacture, testing, or distribution of products or during the administration of quality systems.
7. Identifies root causes, recommends and implements corrective actions to prevent recurrence.
8. Performs trend analysis to monitor process and facility performance.
9. Employs metrics to track the performance of operations and quality systems.
10. Reviews validation protocols and summary reports.
11. Supports other groups on completion of annual review and annual product reports.
12. Performs in-plant inspections of active production areas to resolve problems early and to ensure compliance with SOP and regulatory requirements.
Educational Requirements Typical Education:
Bachelors: Life Sciences
To apply for this position, please visit
this Website.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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