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
