Kit Production Coordinator

Thermo Fisher Scientific•Cincinnati, OH

2d•Onsite

About The Position

This is a fully onsite role based at our Global Central Laboratory in West Chester, OH. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our PPD clinical research team, you’ll have the opportunity to support groundbreaking studies that make a real difference in patients’ lives. As a Kit Production Coordinator, you will have a pivotal role in the flawless production and distribution of laboratory kits. Your contributions will help maintain our high standards of quality and reliability in serving clients and internal teams. Responsible for logistics coordination of moderate to complex studies with little to no supervision. Actively problem solves and suggests solutions to logistics challenges.

Requirements

High school diploma or equivalent required.
Relevant formal academic / vocational qualification.
Technical positions may require a certificate.
Previous experience that provides the knowledge, skills, and abilities to perform the job (1 year and 10 months of experience).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Proficient in English (verbal and written).
Strong computer skills: solid understanding of Microsoft Project, Excel, and Microsoft Word is required.
Proven understanding of the Clinical Supply process, such as manufacturing, handling, importing, shipping, exporting, auditing, labeling and packaging
Strong organizational, planning and time management skills
Planning analytical skills
Good analytical skills and ability to work on issues of a diverse and confidential nature
Strong customer service orientation and attention to detail aligned with high standards of quality and excellence
Adaptive to changes and ability to handle high-pressure situations
Ability to work in a team environment as well as work independently with moderate direct supervision
Ability to use proper channels of communications to voice concerns and suggestions

Responsibilities

Coordinates, supports and performs logistics and administrative work to support the department.
Supports the day to day operations of the study drug, comparators and ancillaries management.
Ensures all activities are executed in compliance with company good practices and client requirements.
Completes ongoing training on new regulations concerning all clinical supplies and GxP activities.
Participates in and supports department project teams.
May coordinate or serve as a liason cross-functionally.
Oversee the daily drug product/medical device receipt, ordering, storage, label printing, labeling activities, inventory management, distribution, return drug accountability and destruction
Ensure all activities executed by PPD Depots comply with company SOPs, and client requirements.
Track inventories and expiration dates of all department drug products and medical devices.
Issue monthly status reports.
Arranges purchases of additional supplies upon request.
On going Training on new Regulations concerning GMP activities.
Maintain Updated PPD Owned Metrics Indicators Reports.
Maintains accurate data in electronic management systems for assigned studies.