- Manage and backup the QA IT administrator function to ensure effective and efficient use of the company’s electronic Qumas/LMS systems including SOP’s, change controls, CAPA’s, deviations and training files.
- Manage and be a backup for Review and approve item creation and change activities to ensure items are released per specification with company ERP system
- Manage and backup the release of incoming materials and outgoing products with the company ERP system.
- Maintain Quality Metrics
- Assist with cGMP training of personnel
- Perform annual product review and manage investigations of customer product complaints providing results and response to the customers and product manager.
- Work on various improvement projects to improve quality of process, procedure and/or product.
- Manage and ensure CFR Part 11 and data integrity compliance within the company. Ensure
- Validate quality processes by determining operational and performance qualification; writing and updating assurance procedures.
- Perform internal and supplier audits per established schedules.
- Supports external audits from customers and regulatory agencies.
- Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, employee training and competency, and re-validations of processes/procedures.
- Provide recommendations for and review implementation of Continuous Improvement (CI) projects.
- Demonstration of sound problem-solving skills and troubleshooting abilities.
- Insure Quality System, cGMP and ICH guidelines are followed on site. Conduct annual analysis of upgrades to Quality System in terms of both Operations efficiency as well as new FDA or ICH regulatory changes.
- Cross train and provide backup to other QA department functions as required.
- Other duties as assigned
Requirements: Minimum of a Bachelor’s of Science degree in, Chemistry, Biotechnology or one of the Chemical, or Biological Sciences and relevant previous experience to indicate competency in laboratory procedures.
- Experience in specific laboratory procedures an technical applications deemed sufficient to conduct technical investigations and assess effectiveness of quality management system implementation
- Knowledge of cGMP and ICH Guidelines, specifically CFR Part 11.
- Proficiency in working with electronic document control systems and ERP system
- Solid organization and analytical skills.
- High attention to detail
This position is located in Torrance, CA and does not offer relocation assistance.
Job Type: Full-time
- Quality Assurance: 3 years (Required)