Records Review – 2nd shift at Softworld Inc

Job Title: 80712 - Records Review

Job Location: New Brunswick NJ 08901

Onsite Requirements:

• GMP Experience
• Microsoft Office
• Administrative Experience

Job Description:

• 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.
• Use of computer-based applications to manage:
• Inventories,
• Batch records
• Down time
• Communication
• Inspection equipment
• Inventory equipment