The Quality Assurance Manager will administrate and develop the quality system based on ISO/IEC 17025, and 21 CFR, Parts 11, 210, 211, 610 and 820. The QAM will be responsible for ensuring IT, Facilities, and the labs are 21 CFR Part 11 Complaint during equipment qualification process and through regular data integrity audits. Additionally, they will ensure that all registrations and certifications for the lab remain current.
They will promote continuous improvement of laboratory and business systems with respect to quality. This role will be the face of quality for the entire lab and will interact with customers, vendors and accrediting bodies.
- Lead the ISO/IEC 17025 and 21 CFR, Parts 11, 210, 211, 610 and 820 Quality System at SGS North America Inc. as a system of continuous improvement.
- Responsible for ensuring IT, Facilities, and the Labs are 21 CFR Part 11 Complaint during equipment qualification process and through regular data integrity audits.
- Ensure that all registrations and certifications for the lab remain current.
- Give leadership and develop the quality system with the Qualtrax Document Management System as a tool for achieving ISO/IEC 17025 requirements and the cGMP compliance in Christiansburg.
- Provide quality approval for all documentation related to work instructions.
- Provide one of two approvals for all approvals related to Quality Procedures or major system changes.
- Lead and administer the Qualtrax Document Management system.
- Oversee the schedule, training, execution and, closing of the Internal Audits each year.
- Oversee all non-conformances resulting from Internal and External Audits, Complaints, OOS鈥檚 and any other investigations ensuring that the system is suitable for compliance and business practice.
- Execute all quality agreements or quality surveys sent by the customer.
- Lead all customer audits, or regulatory body audits representing SGS North America Inc. and providing the required documentation, interaction, and completion of any resulting actions.
- Interact with all lab staff as necessary to ensure that all quality requirements are understood and executed through effective communication and training.
- Oversee the Quality Control System including leadership of any changes or improvements.
- Lead Root Cause Analysis to identify and eliminate sources of non-conformances / lab errors.
- Manage all Proficiency Testing to help support ISO/IEC 17025 accreditation.
- Conduct Management Reviews for local lab leadership to promote continuous improvement and adherence to Quality System.