To apply for this position, please visit this Website.
http://sq
a.fyicenter.com/jobs/99693900.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 27-Jun-2006
QA Associate III
1. Support Clinical Research Department under FDA Good
Clinical
Practice regulations and guidelines through internal and
external
audits. 2. Independently plan, conduct and report audits of
clinical
investigators, vendors, systems, and key reports and
documents. Monitor
audit responses and corrective action to assure accuracy and
consistency. 3. Plan, develop, deliver and document
comprehensive
training programs to personnel involved in or supporting
activities.
Develop and delivery Compliance training at Investigator
Meetings. 4.
Represent QA on appropriate teams to facilitate audit
planning and
timely advice. 5. Assist in regulatory inspections of PDL
facilities.
6. Provide supervision, training and guidance of junior QA
staff as
directed by Management. 7. Keep Management apprised of
compliance and
personnel issues through periodic reports. 8. Maintain good
working
relationships and communication with customers and QA audit
staff. 9.
Other duties as assigned.
1. BS in biological or life sciences, or equivalent with 4-8
years of
experience in GCP QA, or equivalent. Additional experience
in GLP
and/or GMP QA, a plus.
2. Proven experience in conducting detailed external and
internal
audits of Clinical Studies, Vendors, Systems, Data and
Reports.
3. The ability to travel at least 30%.
4. Excellent communication skills, both verbal and written.
5. Detail oriented with proven organizational, leadership
and
negotiation skills.
6. Works under general direction with minimal supervision.
Independently determines and develops approach to solutions.
Work is
reviewed periodically for adequacy in meeting objectives.
7. Proficient in word processing, spreadsheets, and database
software
applications on a PC, specifically MS Office: Word, Excel
and
PowerPoint.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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