Paula Herbers Email & Phone Number

Largo, Fl, Us

West Chester Oh

* Subject Matter Expert on Pharmaceutical Packaging Equipment. * Responsible for the creation and revision of written SOP's for pharmaceutical packaging Equipment. * Active participant in: IQ and OQ Process, Equipment Validation, Operational Validation Processes, and Engineering Trial Runs for new product launch.

Working with the Environmental Management Team in the testing of daily water systems for microbial excursions.Trained in the use of MODA data acquisition software.

* Write, read, edit SOP's* Operate various types of packaging equipment* Specialize in the Set up, Operation and Troubleshooting of the Uhlmann Cartoner C 2206* Cross training - Inspection Dept.* Maintain Compliance training

* Oral dose tablet & capsule blister packaging technician* Experienced in gowning, respirator w/ hood use, cleanroom environment* Provided on the job training for new employees* Fully trained on cGMP documentation practices* Participant in CAPA and Six Sigma projects

Silk-screen printer and laser engraver on pens, lighters, shavers, and flashlights, as well as cello-wrapping , cartoning and shipping the products all over the U.S.

Worked in a clean room environment using ultrasonic cleaners to clean ceramic and beryllium parts, them assemble them and measure the gaps inside to tolerances of 10-20 millionths of an inch. These were used in guidance systems for the MX Missile program and the Trident Submarine program. Was laid off after missile treaty was signed.

Certificate Achieved, Bioscience Manufacturing Technology

Curriculum included: Bioscience in Ohio, Life Cycles of Pharmaceutical Products FDA Regulations, Basic Chemistry, Cells, DNA and RNA.

Computer Science

Activities and Societies: Achieved a 3.5 GPA while working full-time at Honeywell Avionics in St. Petersburg, FL

Education record