What are the responsibilities and job description for the Regulatory Affairs Coordinator position at Marken?
Quality Assurance Associate II
We are seeking a highly motivated Quality Assurance Associate II to join our team at Marken. As a key member of our quality assurance department, you will be responsible for implementing and maintaining our quality systems at the facility in compliance with Marken's Global Quality Management System (QMS) requirements.
Main Responsibilities
- Implement company's quality systems at the facility, ensuring compliance with QMS requirements.
- Interact with clients on Quality Assurance (QA)/ GxP related matters under management supervision.
- Effectively interact with Marken departments and stakeholders to maintain that all QA tasks are appropriately supported by QA.
- Support internal audits, including report preparation and assessment, and tracking of associated corrective and preventive actions (CAPA).
- Support audits of external service providers as part of the vendor selection process. Follow up and track all commitments for actions or changes made by Marken from previous audits, including report preparation.
- Support client audits and regulatory inspections, including the preparation of appropriate materials required within those audits when applicable.
Requirements
- Related knowledge of Good Manufacturing Practice, Good Storage Practice, and Good Distribution Practice guidelines.
- Detailed oriented.
- Oral and written communication skills.
- Good interpersonal skills, understanding of GDP and ISO Compliance.
- Previous experience in Quality Management Systems.
- Organized, methodical, and efficient approach to work.
- Proficient use of Microsoft office.
- Fluent in English.
- Minimum of 1 year of experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position.
- Minimum High/ Secondary School diploma/ or equivalent with experience in relevant job-related skills.
