Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Responsibilities:

This individual possesses the ability to adapt, work independently and collaboratively on projects as needed, and can apply critical thinking to a multitude of varying, nuanced issues. Globally responsible for Compliance by investigating and resolving internal/external quality events, management of CAPA plans, and supporting central lab Operations in quality issues. 

Coordinates, supports and performs logistics and administrative work to support the department. 

Supports the day to day operations of the study setup. 

Ensures all activities are implemented 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 liaison 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 implemented by PPD Depots align 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. 

Maintain Updated PPD Owned Metrics Indicators Reports. 

Maintains accurate data in electronic management systems for assigned studies

EducationHigh school diploma or equivalent experience is requiredRelevant formal academic or vocational qualification preferred

ExperienceMinimum of 2 years of logistics coordination experienceIn 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.SkillsProven ability to successfully implement logistics strategies and improve operational efficiencyStrong proficiency in Microsoft Office Suite and ability to learn new software quicklyExcellent verbal communication skills and attention to detailDemonstrated ability to maintain confidentiality and handle sensitive informationProven negotiation and problem resolution skillsStrong time management and organizational skills

Additional / Specific Job Responsibilities:

Sets up and leads meetings pertaining to quality issuesInvestigate and draft quality events (QE)Perform root cause analysisCollaborate with Quality Assurance to ensure accuracy of QE(s)Oversees / manages the group email box, providing key responses to questions and concernsFollows up with necessary staff members to find resolution to identified quality issuesWork with Global Site Services staff or directly with Central Lab contracted vendors to identify or otherwise verify vendor non-complianceEscalates issues to leadership/appropriate departmental leads to ensure satisfaction of internal and external customersFamiliarize oneself with Global Site Services and Sample Management procedures and procedural updatesKnowledge of PPD’s Preclarus® central lab database and/or lab information management system and supporting quality management system(s)Team with subject matter experts in updating/emending standard operating procedures (SOP)Advises subject matter experts / departmental leads of quality concerns that may affect SOPsTrack / notate status of quality events and SOPs for Global Site Services and Sample ManagementBenefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response