Janessa Booth Email & Phone Number

Bend, Or, Us

Bend, Oregon, United States

Cleaning method development and validation.Method transfers, validations, co-validations and qualifications.Technical review, raw data review and audit trails. One of the major contributors to qualification of equipment bringing new laboratory to full functioning. Maintenance, and troubleshooting of High-Performance Liquid Chromatography systems.Drafting, collaboration and review of SOP’s, process instructions and other GMP documents.SME Dissolution apparatus.cGMP regulations and related public quality standards.Mentoring and training of employees.

Bend, Oregon, United States

GMP method development, release testing and stability assessment. Conducts appearance testing, solution preparation, and pH measurements.Running Assay and Purity QC analytical testing to determine the components of a sample. Dissolution testing in conjunction with LC (HPLC) to quantify the rate of API release from the solid dosage form.Water Content determination using the Karl Fisher Volumetric Titration, and Karl Fischer Coulometric Titration.Technical data review, method development, transfer and validation activities. Laboratory chromatography software and laboratory data review activities.Maintenance, and troubleshooting of High-Performance Liquid Chromatography systems.Drafting, collaboration and review of SOP’s, process instructions and other GMP documents.Role modeling, mentoring and training of employees.SME Dissolution apparatus.

Bend, Oregon, United States

Bend, Oregon, United States

Continuation of ISO:13485:2016 certification through internal auditing and supplier auditing, Change Control, Corrective Actions, SCAR's, Preventive Actions, Deviations, Document control, NPI (Life Cycle Management), Design Transfers, Risk assessments and Validation records.

Bend, Oregon, United States

Revise standard operating procedures and adjust work orders and consumption of materials. Review and submit Certificate of Conformance and Certificate of Compliance for Production. Collaborate with management to discuss effective plans for resolving major quality problems. Measure contact angle on many different surfaces and materials using the FTA1000 goniometer for materials testing and root cause analysis. Perform frequent QA product quality evaluations for Grace Bio Labs, including leak testing and root cause analysis to verify proper bonding between material and substrates. Increase process improvement initiatives by troubleshooting problems for corrective action to boost functionality and workflow. Inspect quality of finished products, as well as performing in process inspections making minor repairs to meet project expectations. Collaborate in creation of material inspection criteria for products aligning to engineering standards. Close-out nonconformities and identify the root cause and corrective/preventive actions associated with nonconforming product.

Bend, Oregon, United States

Quality Assurance verification of aircraft build recorded during FAA certification program, Created and Managed Quality Assurance Administration position in the Composite Fabrication department, Created Non-Conformity Reports for Government Agency review when parts did not meet engineering design, Audited all Quality procedures in accordance with Government Agency requirements. Excellent trouble shooting skills while locating all required documentation and identifying any errors. Used existing programs and documents to track progression of parts. Assisted others in locating and creating appropriate documents.

Bachelor Of Science - Bs

Administrative Business Systems