Leading global biotechnology manufacturing organization is seeking a qualified Quality Assurance manager to lead Q/A team(s) and oversee quality management systems.
Quality Assurance Specialist
Houston, TX
M-F 8am-5pm
Must be able to work onsite everyday
Pay: 45.00-50.00/hour
Key requirements:
- Minimum 5 years’ experience cGMP environment and related QA field
- Must have KPI and/or KQI experience
- Must have Trackwise experience
- Must be proficient in Excel
Key responsibilities:
Lead Quality Council and Quality Management Systems program by:
•Facilitates the implementation of quality systems and compliance initiatives projects at the site
•Identifies, maintains and reports site quality KPIs for Quality Council
•Responsible for ownership of the site’s Quality Council program, including hosting and ensuring participation of SMEs in monthly Quality Council meetings
•Reports site quality KPIs in KPI reporting system monthly
•Identifies actions required to meet site KPI targets and facilitates with SMEs activities necessary to meet those targets
•Supports and hosts change controls review board, deviation review board and CAPA review board.
•Responsible for site monthly and quarterly trending program and associated reports
•Identifies and facilitates 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