Role Description
This position is responsible for managing, implementing and overseeing the ISO Quality Management System and Good Manufacturing Practices compliance activities to ensure continuing conformance to documented standards.
• Oversee and manage implementation and maintenance of the quality system process for the operations to ensure continued ISO 9001 certification.
• Partner with process owners in supporting ISO/GMP policies, procedures and maintenance of internal documents in accordance to the governing standards.
• Coordinate, manage the facilities internal audits process including completion and reporting of audit results.
• Manage, report and monitor the facilities internal Corrective Action Process (CAP) to ensure issues are resolved and closed.
• Provide, implement and support internal training activities as it related to ISO requirements and GMP compliance.
• Lead and support third-party audits (ISO, FDA, Client, Security) acting as organization facility Management Representative.
• Coordinate and manage the ISO Management Review process.
• Support and development of internal client requirements as it related to compliance activities.
• Support facility client activities as requested by internal teams to validate process monitoring, data collection and adheres to ongoing compliance initiatives.
• Monitor changes to governing standards and identify internal changes required to support requirements.
• Work directly or indirectly with clients to support client requirements and adherence to facility implementation requirements.
• Support the development, implementation and revision of company policies and procedures.
• Regular and punctual attendance.
• Perform other internal duties and responsibilities as required.
Qualifications
• Post secondary education, preferably with a quality or compliance focus, or equivalent work experience.
• 3 - 5 years work experience in a quality and/or compliance management position.
• ISO quality and GMP compliance experience required.
• Problem solver with the ability to collect and analyze data to foster valid conclusions and decisions.
• Strong PC skills.
• Proven organizational, time management, and attention to detail skills.
• Ability to communicate effectively at all levels both internally and externally.
• Ability to work independently and in teams.
• Ability to handle stressful situations with tact and control.
• Ability to work autonomously.
Benefits
• Remote work opportunity on the West Coast.
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