Description

Title:

Key Account Excellence Investigation Writer

Job Purpose:

Investigation Writer is responsible for the initiation, investigation and completion of process deviations related to our Key Accounts. They identify and investigate process deviations to find the cause, assess impact, and implement corrective and preventive actions to prevent recurrence. Technical Writer perform all Effectiveness Checks requires for the associated written investigation.

Investigation Writer is expected to work in a cGXP environment, have working knowledge of cGxP processes, the ability to manage multiple ongoing projects concurrently and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigation.

Main Duties and Responsibilities:

• Act as an Issue Reporter, Lead Investigator and provide a high-Quality standard to the investigation within the systems and CIR (Client Investigation Report) to Key Account defined scope.
• Able to report within the systems and make sure all information are accurate
• Conduct detailed and structured investigations through data collection, collaboration, interviews and analysis to determine root causes.
• Write Investigation reports and summaries clearly and promptly to ensure Key Account and Marken timelines are met, and information is accurately conveyed.
• Work with the functional areas to identify the root cause and determine appropriate preventive and corrective action to prevent recurrence.
• Perform all Effectiveness checks required for the associated investigations written.
• Lead and support prompt investigations are performed in compliance with Marken’s procedures and Client’s requirements documentation.
• Issue escalation and mitigation, work with Key Account Excellence Team members to identify trends on investigations.
• Participate actively in all meetings to update management, peers, sites on current deviations
• Act as a method SME (Senior Matter Expert) for root cause analysis tools and general problem-solving techniques.

Requirements:

• Knowledge of Good Manufacturing Practice, Good Storage Practice and Good Distribution Practice guidelines.
• Previous experience in Technical Writer, Customer Services or quality management with an eye for details.
• Knowledge of local regulations.
• Six Sigma certified preferred.
• Strong written and verbal communication skills are required. Ability to read and comprehend complex subjects.
• Organized, methodical and efficient approach to work.
• Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint).
• Fluent in English
• Ability to work in a fast-paced, high workload environment, and balance multiple projects and objectives for timely event closure.
• Collaboration skills, with the ability to troubleshoot and problem solve in a cross-functional team setting.

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.

Moving Our World Forward by Delivering What Matters.