Darrell Browning

• Mentor new operators on all prep and formulation task .
• Adhere to standard operating procedures and cGMP requirements.
• Design and set up pattern loads for Parts Washers and Autoclave loads.
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• Wrote and executed validation protocols and summary protocols.
• Effectively work with operations / support groups to ensure conformance to validation schedule.
• Ability to analyze and troubleshoot issues while executing protocols.
• Mentor operators and process team members on validation topics.
• Trained to perform Cleaning Validation testing which included swabbing for TOC, Microbial and Rinse samples.

• Adhere to SOP's and cGMP practices.
• Set up and operate Parts Washers and Autoclaves for Filling activities.
• Follow schedule to ensure no downtime occurs related to prep activities.
• Perform routine sanitization in classified areas to maintain the sterility of the area, operation and product.

• Supervised daily production operations to maintain cGMP compliance and consistent workflow execution.
• Coordinated cross-functional teams to resolve quality issues, deviations, and batch record discrepancies.
• Trained associates on safety procedures, standard work, and equipment operation requirements.
• Monitored manufacturing schedules to support on-time completion and minimize process interruptions.

• Adhere to SOPs and cGMP practices.
• Set up and operate Parts Washers and Autoclaves for Filling activities.
• Perform routine sanitizations in classified areas to maintain the sterility of the area , operations and product.
• Follow schedule to ensure no downtime related to prep activities.

• Perform Viable and Non-viable sampling in classified areas.
• Perform Utility sampling on all process which included

WFI and WBSO sampling, Process Nitrogen , Process Air and Clean Steam sampling.

• Aseptic gowning certified to perform sampling in grade A classified areas.
• Date entry for testing and results.