Monitors equipment and manufacturing process. Sets-up, cleans-up, and maintains equipment. Reacts appropriately to unanticipated conditions and intended actions, troubleshoots problems, and informs supervision. Observes quality characteristics of products and processes and understand the impact to the product. Completes documentation per current good manufacturing practice guidelines and policies.

Responsibilities

• Learn and follow department policies, procedures, and guidelines. Complete documentation and supporting data per current good manufacturing practice policies, procedures, and guidelines. Note quality issues and initiate, review, and address with appropriate people.
• Review procedures and batch records, and make suggestions for improvements. During pre runs, post runs, and when reviewing direction sets identify issues (safety and process) and help to correct them. Routinely involved in initiating or writing basic operating procedures. Considered an expert on department procedures and processes.
• Consistently give an accurate and complete material and equipment status report when handing off manufacturing process. Set up equipment to accommodate minor processing changes. Assist in the preparation for upcoming projects for process.
• Assist with engineering and validation groups to implement new equipment into operations. Be actively involved in Validation activities.
• Communicate with warehouse to ensure timely and proper staging for process. Acknowledge commodity needs and order needed supplies.
• Assist as back up Team leader and/or floor trainer, if applicable.
• Perform analytical calculations for equipment as necessary. Inspect equipment for cleanliness and sign off per procedure at the end of the process.
• With the help of process support, identify process hold points and arrange work schedule to meet the needs of the process.
• Assist vendors, safety engineering, maintenance and other applicable areas with the implementation of safety changes and concerns.
• Consistently provides process feedback or participates in tasks that demonstrate a fundamental understanding of GMP manufacturing requirements.