Susan Mitchell Email & Phone Number

Minden, Nv

•Ensure all industry and company required protocols and procedures are met and followed during production processes.•Sample, test, record and review of all data pertaining to quality samples collected during manufacturing processes. •Sampling includes equipment swabbing, collection of rinse samples and product samples at various locations throughout the production processes, water and wastewater treatment ports and environmental monitoring sites.•Testing includes COD, DO, pH, titratable acidity, bioburden, microbial identification, dissolved solids determination, viscosity and viable air monitoring.•Final product testing includes label verification and paperwork documentation, container weight and headspace, production line checks and overall quality of each package shipped .•Oversee product changeover processes. •Collect and test all product changeover related samples per cleaning protocol.•Quality disposition of production equipment following testing and review.•Initiate non-conformance investigations to determine root cause, effects of deviation and initiate potential corrective actions as deemed necessary. •Develop and revise testing protocols and SOPs to ensure compliance with regulatory agencies.•Improve and ensure company adherence to cGMP and HACCP requirements.•Partnering with multiple internal departments to successfully attain SQF Level III certification.cation.

Incline Village, Nv

•Sold tickets to customers on site and over the phone.•Resolve any issues that arose due to miscommunication or technical glitches.•Accounted for all cash and credit sales at the beginning, during and end of shift.•Oversaw and managed amphitheater, ensuring venue was patron friendly and organized•Assisted patrons in seating and locating other ammenities associated with Sand Harbor State Park•Worked in a team environment that included managing volunteers.

Seattle, Wa

•Issue, verify and review clinical and commercial drug product batch records.•Disposition clinical and commercial drug product and raw materials.•Revise and review GMP controlled documents including Standard Operating Procedures, Batch Records and Test Methods for cross-functional departments.•Preapproval Inspection (PAI) and commercialization support.

•Oversaw all scheduling, analysis, review and release of all product changeover, cleaning validation and environmental monitoring (EM) related samples. Released approximately 250 pieces of manufacturing equipment back into production and managed approximately 1000 samples on an annual basis. •Successfully drafted and executed eleven different Total Organic Carbon (TOC) product recovery and stability studies.•Designed, drafted and executed several cleaning agent technical studies that evaluated different cleaning agents employed during the PCO cleaning process. Technical studies and associated report ensures FDA compliance, justifies PCO acceptance criteria and demonstrates the effectiveness of the cleaning program.•Served as the TOC and conductivity technical expert for the Amgen Washington site.•Demonstrated prompt problem resolution among customers to ensure process improvement in a dynamic, fast paced and results driven atmosphere.•Initiated and wrote QC Microbiology Planned Deviations, Non-Conformance and Corrective Action (NC/CAPA) reports.•Reviewed proposed changes by USP to chapters <643> (TOC) and <645> (Conductivity). Contributed comments to Corporate Quality that were submitted to USP for consideration.•Hosted auditors (FDA, European Union and internal) on a routine basis; assessed, corrected and prevented recurrence of regulatory infractions.•Validated all TOC instruments and conductivity meters to meet requirements of cGMP guidelines and CFR 11.•Proficient in TOC, conductivity, pH, endotoxin, Q-PCR (mouse minute virus), biological indicator, bioburden, microbial identification testing and air sampling (including viable, non-viable and compressed).•Assisted in numerous microbial contamination investigations.•Served as subject matter expert in water chemistry, routinely trained, maintained and approved staffs work on TOC, conductivity and pH.•Mentored a summer intern on a research project.

•Performed routine and research speciation analyses of Cr, As, Se, and metal cyanide complexes using ion chromatography coupled with inductively coupled plasma – mass spectrometry, ultraviolet - atomic fluorescence spectrometry and hydride generation - atomic fluorescence spectrometry.•Determined total and weak-acid dissociable cyanide using modified EPA methods 1677 and 1678. •Conducted experiments for EPA grants and method development on the extraction of Cr (VI) in fish tissue and the feasibility of a portable hydride generation-AFS detector for low level As speciation in waters.•Performed analyses on samples for total solids, total suspended solids, and iron via colorimetric determination.•Proficient in ultra-clean sample preservation and preparation of different matrices including effluents, seawaters, tissues, and sediments. Tasks included training new staff, pipette calibration, and sample tracking. •Other responsibilities included method optimization, instrument maintenance, data evaluation, and report generation.

Greater Seattle Area

•Directly monitored and oversaw the stewardship of twenty Department of Natural Resources salmon habitat restoration sites. •Evaluated streamline planting and restoration plans. •Directed working crews and implemented resource adjustments to restore stream habitat. •Synchronized watering schedules. Organized and coordinated volunteers for DNR sites. •Assisted and organized in all facets of environmental restoration.STREAM RESTORATION:•Minimized erosion and decelerated stream flows via bioengineering applications. •Analyzed stream flow and assisted in restoration planning. •Stabilized banks by planting native flora and adding gabions.TRAIL RESTORATION:•Assessed and projected erosion stabilization. •Constructed turnpikes, drainage ditches and bridges. •Graded slopes to redirect water, minimize erosion and human impact in sensitive areas.WETLAND RESTORATION:•Improved delineated wetlands by drafting and implementing planting plans and redirecting water sources. •Worked in coordination with Army Corps of Engineers and Department of Natural Resources to monitor and implement site improvements.

Bachelor Of Applied Science (B.A.Sc.), Environmental Sciences, Pollution Treatment

Activities and Societies: Four years active member of intramural soccer and floor hockey.

High School Degree, Regular/General High School/Secondary Diploma Program

Activities and Societies: •Fours soccer team member, captain one year. •Fours lacrosse team member, captain one year.