Keywords Studios is hiring a
Associate

Summary

Join Keywords as a coordinator in deviation management at their Pharmaceutical client's Temperature Excursion Investigation Center (TEIC). The role involves managing temperature excursions with exceptional customer focus to final material disposition. Responsibilities include responding to submissions and communications, collaborating with teams, meeting cycle time expectations, monitoring issues, and implementing solutions.

Requirements

• Prefer Experience with Distribution – preferably Clinical Trial, Clinical Research, Distribution or Supply Chain
• Strong attention to detail and accuracy
• Ability to manage multiple priorities and meet timelines
• Ability to build collaborative working relationships and work in a team environment
• Good written and verbal communication skills in a multi-cultural settings
• Ability to proactively identify and solve problems
• Learning agility and self management skills
• Ability to learn a variety of IT systems (e.g. CT Win/SAP)
• Experience with Microsoft Office

Responsibilities

• Manage the temperature excursions with exceptional customer focus to final material disposition
• Respond to all Temperature Excursion submissions and communications swiftly, clearly and accurately
• Collaborate with the Development Stability Group, Clinical Supply Coordinators, Global Distribution and others to provide Fit for Use disposition, resolve issues and ensure adequate supply is available at sites to avoid patient impact
• Meet or exceed current cycle time expectations for each step of the process applicable to TEIC role
• Monitor and escalate issues in a timely manner
• Follow all procedures for determining material disposition and create clear documentation of all decisions to demonstrate a controlled process
• Identify communication and/or process gaps and initiate solutions. Implement and monitor key measures and metrics to demonstrate compliance and process execution
• Develop and implement methods to measure customer satisfaction
• Create and develop tools to assist in supporting the effective execution of the process
• Lead and ensure consistency in appropriate training materials and procedures are created, maintained, and governed
• Assist in identifying the root causes of any process related issues, affecting, but not limited to compliance and quality
• Contribute to interpreting the GxP Guidelines and other appropriate guidelines and regulations that affect the processes
• Utilize the software application, Trackwise, for daily activities

Benefits

• Paid Time Off (including sick days and holidays)
• 401k (3% matching)
• Medical, Dental and Vision benefits