Quality Assurance Specialist

Responsibilities

• Develop and maintain a strong command of SOPs, cGMPs and associated regulations. Apply this knowledge in the everyday work environment, providing consultation as necessary
• Develop an understanding of the function and basic operation of analytical equipment and techniques to enable effective performance of other duties
• Monitor compliance in the Analytical laboratories and actively participate in resolving quality issues
• Identify quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements
• Assist Analytical staff with change control and CAPA processes, writing deviations and investigations. Identify areas of concern and communicate to management
• Track and manage timelines for analytical quality events and initiatives. Coordinate efforts to ensure timelines are met and when necessary, assist staff with extension requests
• Coordinate periodic review and revision of SOPs
• Review and/or approve (where applicable) SOPs, material specification forms, test methods, instrument qualification protocols/reports, vendor repair/calibration reports, etc
• Assist Analytical staff with review and approval of equipment qualification documentation, including protocols and reports
• Assist Analytical staff with training programs for new hires as well as ongoing compliance awareness for the department
• Assist during regulatory, client, and internal audits including tours of Analytical laboratory areas
• Coordinate Analytical responses generated from regulatory, client, and internal audits. Engage relevant subject matter experts to assist with responses when necessary
• Perform all duties safely in accordance with Curia Safety Program, OSHA requirements, FDA regulations, and all applicable federal, state and local regulations

Benefits

• For temporary assignments lasting 13 weeks or longer, major medical, dental, vision, 401k and any statutory sick pay where required.
• STEM staffing and recruiting services.
• Ontario, California, USA
• https://www.allstemconnections.com
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• *2024
• (1)
• Late Stage
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Required skills

• CAPA, CGMP, Change Control, OSHA Compliance, Quality Auditing, Standard Operating Procedures (SOPs)

Experience

• Mid level