Quality Control Associate II
hace 2 meses
Job Overview
Position: Quality Assurance Associate II
The Quality Assurance Associate II (QAA II) plays a pivotal role in the management and execution of the Marken Quality Management System (QMS). This position ensures adherence to established Standard Operating Procedures (SOPs), processes, and policies necessary for the effective management of storage, distribution, and transportation operations, as well as kit production facilities. The QAA II is also tasked with ensuring compliance with relevant regional and local regulations, as well as customer-specific requirements, including but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485, and ISO 9001.
Key Responsibilities:
- Develop, communicate, and uphold the company's quality systems at the facility, ensuring compliance with Marken's Global Quality Management System (QMS) standards.
- Liaise with clients regarding Quality Assurance (QA) and GxP-related issues.
- Collaborate effectively with various Marken departments and stakeholders to ensure all QA activities receive adequate support.
- Manage an internal audit schedule, conduct internal audits, and prepare reports while tracking corrective and preventive actions (CAPA).
- Evaluate external service providers during the vendor selection process and monitor commitments from previous audits.
- Facilitate client audits and regulatory inspections, serving as Marken's primary representative and preparing necessary materials for these audits.
- Oversee issues and CAPA plans, compile CAPA metrics, and spearhead quality improvement initiatives, ensuring proper closure of all CAPA entries.
- Identify training needs related to GxP/Quality and ensure delivery or facilitation of training where necessary.
- Manage change control processes effectively.
- Ensure the implementation and maintenance of the Marken Quality System and GxP Program.
- Assist in the evaluation of designated vendors and outsourced activities.
- Guarantee the accuracy and quality of records and documentation.
- Monitor and document training for all personnel.
- Coordinate and execute any necessary recall activities promptly.
- Actively participate in all internal Quality and designated meetings.
- Stay updated on regulatory changes in the region and ensure timely updates to SOPs as required.
Additional Duties May Include:
- Conducting QA visual and physical inspections of pharmaceutical products in line with internal procedures and client-specific requirements.
- Reviewing and approving incoming material receipts according to relevant SOPs.
- Verifying and approving label printing processes and additional labeling or repackaging activities.
- Executing QA activities independently for warehouse movements and inventory status control.
General Expectations:
- Complete tasks assigned by QA Management.
- Travel as required by the Line Manager to fulfill job responsibilities.
- Support the line manager in establishing a timely and effective communication process for escalating quality issues to appropriate management levels.
Qualifications:
- Minimum of 2 years of relevant experience in a Quality Assurance role within a GSP/GMP/GDP regulated environment.
- Associate degree or equivalent University Degree/Certification.
- Familiarity with Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice, and Good Storage Practice guidelines.
- Knowledge of local regulations.
- Detail-oriented, organized, methodical, and efficient in work approach.
- Strong interpersonal, oral, and written communication skills.
- Proficient in Microsoft Office applications.
- Fluent in English; multilingual in Spanish and English preferred.
- Previous experience with Quality Management Systems is advantageous.
About Marken:
Marken is a wholly owned subsidiary of UPS and plays a crucial role in UPS Healthcare. The company provides a state-of-the-art GMP-compliant depot network and logistics hubs for clinical drug product storage and distribution globally, supporting cell and gene therapy logistics services from clinical to commercial phases. Marken maintains a leading position in Direct-to-Patient and Home Healthcare services, biological sample shipments, and biological kit production.
Moving Our World Forward by Delivering What Matters.
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