Our Featured Details
CORE COMPETENCIES
Quality Systems Management Support Services
Quality Systems Compliance Review Support
Change Control Review and Approval
Regulated Document Review and Approval
Problem Solving and Root Cause Analysis Support
Software Application Validation Review and Approval
Equipment Validation Review and Approval
Product and Equipment Inventory Management
Facility Inspection and Audit Support
Manage and Support Annual Facility State Licensure
Manage and Support Regulated Agency Reporting
STAFFING SERVICES
Personnel and Leave Time Management
NAICS and PSC Codes
926150 - Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors
325412 - Pharmaceutical Preparation and Manufacturing
325414 - Biological Product (Except Diagnostic) Manufacturing 611430 – Professional and Management Development Training 541611 – Administrative Management and General Management Consulting Services
541618 – Other Management Consulting Services
Past Performance
American Red Cross
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Facility Quality Systems Implementation (Donor and Client Support Center)
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Hired Quality Team for facility oversight.
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Quality Oversight of paper files to electronic document management system
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Facility Change Control Management Quality Oversight
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Facility Software application validation Quality oversight and validation review and approval (Software applications include Odyssey, Gemini, Capstar and Letter Wizard)
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Quality oversight for the consolidation of CBER FDA reporting
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Quality oversight for ARC regional inspection support
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Quality oversight of facility inspections
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Quality team oversight for problem management investigation root cause and corrective action meetings
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Quality oversight of management of suspect products
Company Snapshot
Sharon Weeks, Founder
Phone: (980)999-0185
Email: sharon.weeks19@gmail.com
Address:4374 Hunton Dale Road NW Concord, NC 28027
Work Area: Charlotte, NC
CAGE CODE: 9DTM5
DUNS#:120639764
Website:
