Marken, UPS Healthcare Precision Logistics needs to ensure compliance with the Marken Quality Management System (QMS), Standard Operating Procedures (SOPs), processes, and policies for their Cell & Gene Therapy Network, while also adhering to regional, local, and client regulations such as GMP, GDP, GDocP, and 21 CFR Part 210 and 211.
Requirements
- Demonstrated knowledge of Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practice guidelines.
- Related knowledge of local regulations.
- Relevant technical experience and/or quality experience in a GxP industry or the equivalent combination of relevant education and professional experience.
- Knowledge of cold chain supplies preferred.
- Knowledge of drug product logistics, storage and distribution preferred.
- Six Sigma green belt or equivalent experience is desired.
- Intermediate experience with Microsoft Office Suite
Responsibilities
- Implement, promote and maintain Marken’s Global Quality Management System (QMS) requirements.
- Assist in the Management of deviations, complaints, audit records, CAPA plans, change controls, collation of quality metrics and trending, and identification and implementation of quality improvement initiatives.
- Evaluate the risk and impact of changes within scope of the CGT/QA team and advise on necessary actions, as applicable.
- Assist in internal audits including tracking of associated corrective and preventative actions (CAPA).
- Support Client audits and Regulatory Inspections- participate as a QA SME, prepare requested materials, review/approve Marken audit responses, follow up on CAPA identified.
- Effectively interact with Marken operational departments and stakeholders to provide guidance and quality oversight of all CGT activities ensuring alignment to Marken’s QMS.
- Write the quality processes and procedures associated with job role with management guidance and effective controlled document approval.
Other
- Interact with clients on Quality Assurance (QA)/ GxP related matters under management supervision.
- Identify relevant GxP/Quality related training needs and deliver or make they are deliver where required.
- Keep informed of regulatory changes within assigned Country/Region and promptly escalate changes to management.
- Assisting in the evaluation of Marken-designated vendors and/or out-sourced activities.
- Ensuring the accuracy and quality of records and documents.
- Participate actively in all the internal Quality, CGT and/or other pertinent meetings.
- Travel may be required for the performance of duties.
- Demonstrated ability to effectively communicate and collaborate with direct stakeholders including with customers, vendors, equipment suppliers, and operations staff.
- Excellent verbal, written, and interpersonal communication skills.
- Must be a U.S. Citizen or National of the U.S., an alien lawfully admitted for permanent residence, or an alien authorized to work in the U.S. for this employer.
