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Quality Assurance Associate II
hace 2 meses
Job Title: Quality Assurance Associate II
Job Summary:
Marken is seeking a highly motivated and detail-oriented Quality Assurance Associate II to join our team. As a Quality Assurance Associate II, you will be responsible for ensuring the quality and compliance of our products and services.
Main Responsibilities:
- Quality Management: Implement, communicate, and maintain Marken's Quality Management System (QMS) at our facility, ensuring compliance with global quality management system requirements.
- Client Interaction: Interact with clients on Quality Assurance (QA)/GxP-related matters, providing expert guidance and support.
- Internal Audits: Oversee an internal audit schedule, perform internal audits, and prepare reports, ensuring timely and effective corrective and preventive actions (CAPA).
- Vendor Management: Perform audits of external service providers, tracking and overseeing commitments for actions or changes made by Marken from previous audits.
- Audit Hosting: Host client audits and regulatory inspections, manage audit report responses, and act as Marken's main representative, preparing necessary materials.
- Quality Improvement: Manage issues and CAPA plans, collate CAPA metrics, and identify and implement quality improvement initiatives.
- Training and Development: Identify relevant GxP/quality-related training needs and deliver or ensure they are delivered where required.
- Change Control: Manage the change control process, ensuring that all changes are properly documented and implemented.
- Regulatory Compliance: Ensure that Marken's Quality System and GxP Program are implemented and maintained, ensuring compliance with local regulations and requirements.
- Vendor Evaluation: Assist in the evaluation of Marken-designated vendors and/or outsourced activities.
- Record Management: Ensure the accuracy and quality of records and documents.
- Training Coordination: Monitor that training for all personnel is conducted and documented.
- Recall Activities: Coordinate and promptly perform any recall activity.
- Quality Meetings: Participate actively in all internal Quality and/or designated meetings.
- Regulatory Updates: Keep informed of regulatory changes in the country/region and prompt updates to SOPs as needed.
Requirements:
- Experience: 2+ years of relevant experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position.
- Education: Associate degree and/or equivalent University Degree/Certification.
- Knowledge: Related knowledge of Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice, and Good Storage Practice guidelines.
- Language: Fluent in English; multilingual in Spanish and English preferred.
- Skills: Detail-oriented, organized, methodical, and efficient approach to work; good interpersonal, oral, and written communication skills; proficient use of Microsoft Office.
