Robin Andersen Email & Phone Number

Sanford, North Carolina, United States

Apex, Nc

While caring for family, homeschooled children, volunteered at thrift store, a WCPSS volunteer proctor, Bible Study leader, and Dewberry Engineers contract employee. Worked as teacher assistant with responsibilities of assisting in upper elementary school classrooms. Organized and directed special events at the school. Initiated and sponsored National Beta Club for the high school.

11460 Johns Creek Parkway Duluth, Ga 30097 United States

• Maintained contact lens process validation through the completion of validation master plans• Created validation technical reports and change control assessments• Maintained sterile products, packaging, and filtration programs in a validated state• Developed validation plans and summaries for product transfers• Performed product investigations and annual product reviews and assisted with FDA audits• Trained and supervised new validation personnel on protocols, procedures, and package assembly• Retained products in validated state through compliance with SOPs, cGMP, and FDA guidelines

Greenville, North Carolina Area

• Served as Validation representative on new contract product transfer and new equipment team• Coordinated team, production team, and testing equipment resources to ensure smooth inspections • Prepared validation master plans, determined validation scope, and reviewed technical documentation• Developed process and equipment protocols and coordinated testing• Maintained cleaning validation of new and existing products• Managed installation and validation of multiple new and existing freeze dryers

Greenville, North Carolina Area

• Performed environmental monitoring utilizing aseptic techniques • Examined aseptic areas, Sterile Products Department, Pharmaceutical Development Laboratories, and Quality Assurance Sterile Suites, and executed audits on processes• Completed requalification/validation testing for sterile areas, including troubleshooting problem areas• Validated plate pouring procedures and assisted in authoring applicable procedures and control• Facilitated Sterile Products Facility new employees training, average 1 per quarter• Independently completed routine and non-routine water and bacterial endotoxin testing • Followed SOPs, cGMP and developed and implemented laboratory procedures

Greenville, North Carolina Area

• Performed routine and complex microbial identification of isolates, maintained stock cultures, prepared samples for particulate testing, documented, recorded, and reported results• Executed component validation, container closure integrity test• Followed determinative microbiology validation protocols, Identification methods• Completed routine and complex particle analysis• Trained new employees and cross trained existing employees, average 1 per quarter