Quality Assurance Manager
2 days ago
Job Title: QA Specialist III
Location: Remote
Duration: 6 Months with possibility of extension
Position Type: Hourly contract Position (W2 only)
Key Requirements:
- Minimum 5 years' experience in a Quality Assurance role
- Proven track record in a cGMP environment and related QA field
- Strong background in KPI and/or KQI analysis and reporting
- Experience with Track wise systems and data analysis
- Proficient in Excel and data visualization tools
Key Responsibilities:
Lead Quality Council and Quality Management Systems Program:
- Facilitate the implementation of client quality systems and compliance initiatives projects
- Identify, maintain, and report site quality KPIs for Quality Council
- Own and manage the site's Quality Council program, including hosting and ensuring participation of SMEs in monthly Quality Council meetings
- Report site quality KPIs in client's KPI reporting system monthly
- Identify actions required to meet site KPI targets and facilitate activities necessary to meet those targets
- Support and host change controls review board, deviation review board, and CAPA review board
- Responsible for site monthly and quarterly trending program and associated reports
- Identify and facilitate execution of CAPAs related to identified trends
- Revise or approve quality records (change controls, deviations/investigations, CAPAs, and controlled documents - SOPs, forms, etc.) related to compliance or risk management program
- Perform other duties as assigned
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