Job Description:

• Execution of manufacturing batch records, work instructions and/or SOPs, with focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation.
• Assist in all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
• Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback.
• Critical evaluation of processes, including foresight and thinking ahead.
• Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.
• Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly.
• Participate in shift exchanges, 1-1’s, meetings, attend meetings as necessary to facilitate area needs based on changes, etc. (lean activities).

Job Requirements:
 

• ​Minimum 1 year industry experience 
• Working knowledge of cGMP
• Basic scientific instrumentation experience
• 4 year degree highly preferred