Title
QA Validation Associate
Main Purpose:
The Quality Assurance Validation Associate I is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes, and policies required to manage validation life cycles, calibration and maintenance of equipment/facilities used in support of Marken’s global storage, distribution, and logistics operations.
The Quality Assurance Validation Associate I will also need to ensure compliance with applicable regional and local regulations including but not limited to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), Good Documentation Practices (GdocP), ISO 13485, and ISO 9001.
Maintain, execute, and monitor the global validation/qualification program, including ownership of the validation master plan, re-qualification schedules, and documentation management.
Main Duties and Responsibilities
- Write the quality processes and procedures associated with job role with management guidance and effective controlled document approval.
- Perform/Support the introduction of equipment, systems, and processes through the validation lifecycle process including evaluation, design (URS), installation, operational and performance qualification (IQ/OQ/PQ), calibration and maintenance requirements of equipment, facilities, and utility systems.
- Create, review and/or approve internal validation (VMP, URS, IQ, OQ, PQ protocols, reports, etc), and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
- Review and approve vendor supplied calibration and maintenance documentation for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
- Maintain and monitor the requalification, calibration, and maintenance schedules.
- Coordinate with equipment owners and external venders to always maintain equipment and facilities in a compliant state.
- Supports site operational teams during fieldwork and execution of validation protocols.
- Evaluate the risk and impact of equipment/facility changes to the validated, calibrated, and maintained status and advise on necessary actions, as applicable.
- Solves validation execution issues using critical analysis skills and develops sound, reasoned solutions and recommendations.
- Support/Lead Marken deviations, CAPAs, risk assessments, and change control.
- Deliver training on execution of validation requirements, as applicable.
- Support internal and external audits (e.g., client and regulatory inspections), including the preparation of appropriate documentation, when applicable.
- Collate KPI data and reporting associated with Marken’s validation, calibration, and maintenance program.
- Travel may be required for the performance of duties.
General
- Implement, communicate, and maintain company’s quality systems at the facility, in compliance with Marken’s Global Quality Management System (QMS) requirements.
- Fluent In English. Multi-lingual (desired), dependent on recruiting area.
- Demonstrated knowledge of GxP regulations - Good Manufacturing Practices and/or Good Distribution Practices.
- Effectively interact with Marken Departments and stakeholders to maintain that all QA tasks are appropriately supported.
- Organized, methodical and efficient approach to work.
- Excellent verbal, written, and interpersonal communication skills.
- Demonstrated ability to prioritize tasks.
- Demonstrated ability to effectively communicate and collaborate with direct stakeholders including with customers, vendors, equipment suppliers, and operations staff.
- Perform activities assigned by the QA Management.
- Support QA team to ensure a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
Requirements
- Organized, methodical and efficient approach to work.
- Excellent verbal, written, and interpersonal communication skills.
- Demonstrated ability to prioritize tasks.
- Demonstrated ability to effectively communicate and collaborate with direct stakeholders including with customers, vendors, equipment suppliers, and operations staff.
- Proficient use of Microsoft Office
- Hands on experience with temperature monitoring devices
- Temperature mapping of CTU’s (controlled temperature units)
- Bachelor’s degree required.
- 1-2 years of relevant validation experience and/or quality experience in a GxP industry or the equivalent combination of relevant education and professional experience.
Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.
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