Records Reviewer - 3rd Shift

Kelly Science and Clinical FSP is currently seeking a (insert job title) for a long-term engagement in Raynham, MA with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Records Review - 3rd Shift

The schedule is for 3rd shift (10pm – 6am).

The week start Sunday at 10pm ending Friday at 6am

Responsible for ensuring company products comply with internal and external specifications by performing a variety of routine and non-routine inspections and evaluations. This includes activities related to Inspection and Testing, Batch Release and Records Management.

• Batch Release and Records Management
• Audits batch records to ensure compliance with policies, procedures and regulations.
• Ensures batch records are complete and accurate, with all NC’s dispositioned prior to release.
• Identifies, records and reports on batch non- conformances and product holds.
• Stores and maintains batch files either physically or electronically based on established guidelines.
  
  

General Responsibilities

• Applies principles of Good Documentation Practices.
• Executes assigned NR actions within the applicable software application.
• Provides metrics and updates on executions.
• Maintains training records up-to-date.
  
  

Posted By: Karli Minor