Process Operator/ Batch Record Specialist
Job Responsibilities:
- Reports process or equipment problems to supervisor; performs minor or basic troubleshooting. ;
- Ensure batch records, equipment logbooks, and other relevant records are current; performs batch record reconciliation. ;
- Maintains records of manufacturing process by recording data on batch record. ;
- Sets-up and operates equipment for processing operations. ;
- Communicates effectively with previous and incoming shift operator and related personnel. ;
- Cleans and maintains processing rooms and equipment. ;
- Monitors process and equipment and make necessary adjustments to maintain batch record specifications. ;
- Conducts in-process testing. ;
- Checks and adjusts calculations. ;
- Checks/reviews labels and batch records for accuracy. ;
- Suggest improvements in methodology or process. ;
- Follows established department SOP’s and batch record instructions. ;
Skills:
- Pharmaceutical background or someone that is capable of learning quickly. ;
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements. ;
Education/Experience:
- High school diploma or GED certificate ;
- Fluent in English speaking, writing and reading ;
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