Quality Assurance Specialist
hace 20 horas
We are seeking a highly skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for leading effective CAPA management, ensuring compliance with ISO 9001 requirements, and contributing to the continuous improvement of our Quality Management System.
Key Responsibilities- Coordinate the Quality documentation control system to ensure updated procedures of key tasks carried out by different functional areas.
- Follow-up CAPA management in Entropy for timely completion and proper documentation of effective action plans of quality incidents.
- Ensure closure of follow-up activities recorded in the Quality Master Action Plan (Q-MAP).
- Facilitate the progress of consumer and customer complaints through accurate traceability, investigation, documentation, and timely closure of each complaint.
- Collaborate with Manufacturing, Maintenance, Procurement, Planning, GSARA, RD&E, and Quality Engineering teams to support complaints or GEN23 related activities.
- Validate proper update of controlled chemical substances records to ensure regulatory compliance.
- Perform quarterly reviews of Quality Risk and Opportunity Matrix with functional areas.
- Support additional external audits requirements as requested.
- Bachelor's degree in Engineering, Chemical, or relevant field.
- Strong problem-solving and analytical skills.
- Familiarity with and experience in Quality Management Systems, ISO 9001, and Good Manufacturing Practices (GMP).
- Solid knowledge of CAPA Management.
- Effective communication skills, both written and verbal.
- Highly organized and detail-oriented with strong follow-up skills to manage large volumes of documentation.
- Computer skills including Microsoft Word, Excel, SAP, Entropy, and Sharepoint.
- English language proficiency at intermediate to advanced level.
- $85,000 - $110,000 per year.
- Full-time position with 5 days/week, Monday to Friday schedule.
- Remote work option available once a week for eligible employees.
We recognize the breadth of human experience and strive to create a diverse, inclusive, and supportive work environment where all people can thrive.
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