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.

-Ability and/or Skills (BMQ):

-Strong organizational skills, problem solving, attention to detail and PC skills required.  

-Experience with Excel, Access and GPM a plus