Tyrone Mitchell Email & Phone Number

Huntsville, Al, Us

Huntsville-Decatur-Albertville Area

Collaborated with Operations, Supply Chain, Quality, and Customer Relations, under FDA and DEA guidelines, to facilitate standard technical transfers and process validations, per customer contract, of liquid and semi-solid pharmaceuticals. Monitored process conditions, collected samples, and analyzed data. Provided troubleshooting and technical support to Operations to help meet safety, quality, and production goals. Initiated and routed change controls to ensure timely approval of document changes. Authored validation protocols and reports. Supported Senior Process Engineers and Production in daily activities. -Validated and launched 11 products to commercial status.-Simplified batch record formats.

Huntsville-Decatur-Albertville Area

Monitored and documented processes to create new work instructions. Updated document database and document formats. Assisted Quality Techs with quality checks by collecting data and burn-in of machinery. Kept log of work-in-process and completed machines. Supported Manufacturing, Sales, and Engineering Departments in daily activities.-Obtained ISO 9001-2015 internal audit certification and assisted with preparation of the successful audit that led to the company's ISO 9001 certification with zero deficiencies.

Huntsville-Decatur-Albertville Area

Monitored process conditions, and provided troubleshooting and technical support to assist in meeting safety, quality, and production goals. Assisted in implementation of process improvements, scale up activities, and validation of new and existing products. Assisted in data collection and writing of technical documents to support development, submission, and ongoing manufacture. Coordinated change controls to support and worked with Document Control group to ensure timely approval of documents. Supported Process Engineers in daily activities.