Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Summary:

Essential Duties and Responsibilities:

Applies Good Manufacturing Principles in all areas of responsibility.Demonstrates and promotes the company vision.Manage receipt of randomization data in accordance with FCS SOPS.Review and update randomization date to ensure compliance with formatting requirements in accordance with FCS SOPs and policies.Provide guidance and verification for third party patient randomizations and material lists.Teams with Cenduit for randomization and material list generation.Update SOPS as required for evolving processes.Review and approve PASS Definitions to allow accurate barcode scanning in Operations.Maintain data in FCS Systems for use by other departments.Provide data related process support for GPM/PASS to all departments.Maintain sufficient knowledge of other department’s processes, procedures and policies to support their data requirements.Provide training to other departments or sites as required.Establish processes and communicates with new and existing depots globally.Collaborate with IT/IS to assist in resolving Operations, Inventory and Distribution issues.Participate in User Acceptance Testing, when required, for upgrades to GPM/PASS.Participate in User Acceptance Testing, when required, for new automated labeling/data equipment.Communicate effectively with all levels of employees/management on all data related issues.Obtain sufficient knowledge of TrackWise and perform assigned tasks within it as requested.May be required to participate on a project team within the department, or in conjunction with other departments.May be required to attend Client audits to provide information on Data Control process and procedures.May be required to train new hires or back-ups on Data Control processes and SOPs.Conducts all activities in a safe and efficient manner.Other duties may be assigned to meet business needs.

Basic Minimum Qualifications (BMQ):

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. 

Education/ Experience (BMQ):

BA/BS from an accredited college or university.  Proficient computer skills, particularly Microsoft Office.

Add’l preferences:

Information Technology experience including relational databases.