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 ;