Quality Control Supervisor

• Sep 2022 - Present

QA/QC Specialist

• Feb 2021 - May 2022

• Implemented the Document Control program. • Managed the control of changes and release of documents within document control by creating, review and updating documents, SOP, specifications and forms for all departments. • Maintain compliance with all regulatory and company specification. • Support and prepare for regulatory audits. • Perform testing of raw material for compliance to specifications. • Assist with AQL sampling of in-process and finished product in order to… Show more • Implemented the Document Control program. • Managed the control of changes and release of documents within document control by creating, review and updating documents, SOP, specifications and forms for all departments. • Maintain compliance with all regulatory and company specification. • Support and prepare for regulatory audits. • Perform testing of raw material for compliance to specifications. • Assist with AQL sampling of in-process and finished product in order to confirm conformance to requires attributes and variables. • Review of Quality documentation • Communicate with vendors for Supplier Notification Reports concerning raw materials, packaging or ingredient. • Maintain Training files and Matrix. • Assist with trainings for orientation and quality. • Maintain lab equipment for in process testing. Show less • Implemented the Document Control program. • Managed the control of changes and release of documents within document control by creating, review and updating documents, SOP, specifications and forms for all departments. • Maintain compliance with all regulatory and company specification. • Support and prepare for regulatory audits. • Perform testing of raw material for compliance to specifications. • Assist with AQL sampling of in-process and finished product in order to… Show more • Implemented the Document Control program. • Managed the control of changes and release of documents within document control by creating, review and updating documents, SOP, specifications and forms for all departments. • Maintain compliance with all regulatory and company specification. • Support and prepare for regulatory audits. • Perform testing of raw material for compliance to specifications. • Assist with AQL sampling of in-process and finished product in order to confirm conformance to requires attributes and variables. • Review of Quality documentation • Communicate with vendors for Supplier Notification Reports concerning raw materials, packaging or ingredient. • Maintain Training files and Matrix. • Assist with trainings for orientation and quality. • Maintain lab equipment for in process testing. Show less

QA/QC Manager

• Apr 2019 - Dec 2019

• Development and execution of product safety and quality programs. • Ensure all quality standards, specifications and policies are met or exceeded. • Developed, implemented, reviewed, and maintained product safety and quality fundamentals. • Created, reviewed and updated documents, SOP, Work instructions, procedures and forms for the Quality and other Departments. • Assisted in all audits as applied to Quality Assurance • Work on GMP programs and training • Assist other… Show more • Development and execution of product safety and quality programs. • Ensure all quality standards, specifications and policies are met or exceeded. • Developed, implemented, reviewed, and maintained product safety and quality fundamentals. • Created, reviewed and updated documents, SOP, Work instructions, procedures and forms for the Quality and other Departments. • Assisted in all audits as applied to Quality Assurance • Work on GMP programs and training • Assist other Locations for Audit preparations for SOP, procedures, HACCP plan. • Worked on all shipments of product for Quality and product standards before shipment. • Investigate deviations, and lab results for non-conformance. • Ensure compliance with all applicable regulatory agency requirements and procedures. • Review of all Quality documentation • Metrc, Confident Cannabis usage and movements for testing, and products transfers • Managed Sanitation Staff Show less • Development and execution of product safety and quality programs. • Ensure all quality standards, specifications and policies are met or exceeded. • Developed, implemented, reviewed, and maintained product safety and quality fundamentals. • Created, reviewed and updated documents, SOP, Work instructions, procedures and forms for the Quality and other Departments. • Assisted in all audits as applied to Quality Assurance • Work on GMP programs and training • Assist other… Show more • Development and execution of product safety and quality programs. • Ensure all quality standards, specifications and policies are met or exceeded. • Developed, implemented, reviewed, and maintained product safety and quality fundamentals. • Created, reviewed and updated documents, SOP, Work instructions, procedures and forms for the Quality and other Departments. • Assisted in all audits as applied to Quality Assurance • Work on GMP programs and training • Assist other Locations for Audit preparations for SOP, procedures, HACCP plan. • Worked on all shipments of product for Quality and product standards before shipment. • Investigate deviations, and lab results for non-conformance. • Ensure compliance with all applicable regulatory agency requirements and procedures. • Review of all Quality documentation • Metrc, Confident Cannabis usage and movements for testing, and products transfers • Managed Sanitation Staff Show less

Sr. Document Control Specialist

• Jan 2016 - Apr 2019

• Maintain and update all documentation of the Quality Assurance departments o SQF Program o In Line QA Audit reports o Audit reports o Organic Certification o Mock Recall Program o HACCP Binder o Internal Audit Binder o Food Safety Plan o Audit information o Daily Production Paperwork • Maintain KPI for the QA Department • Investigates customer complaints, and corrective actions • Conducts Job Hazard Analysis pre-employment… Show more • Maintain and update all documentation of the Quality Assurance departments o SQF Program o In Line QA Audit reports o Audit reports o Organic Certification o Mock Recall Program o HACCP Binder o Internal Audit Binder o Food Safety Plan o Audit information o Daily Production Paperwork • Maintain KPI for the QA Department • Investigates customer complaints, and corrective actions • Conducts Job Hazard Analysis pre-employment assessments • Establish and maintain Specification Books for products produced. • Create, edit and maintain Document Control SOP, forms, work instructions, ensuring Document Control requirements are followed – Reno and Amarillo Locations. • Maintain Controlled Document Master List, current and archived versions – Reno and Amarillo Locations. • Assisted in all audits from customers & all 3rd parties as applied to Quality Assurance • Review raw material for compliance to specifications • Prepared Certificate of Analysis for Customers • Communicate with vendors for Supplier Notification Reports concerning raw materials, packaging or ingredient. • Maintain Training files and Matrix. • Maintain detailed file and organization systems • Assist in maintaining SQF Certification Level 3 • Work on Food Safety, GMP & HACCP programs and training • Started and maintained the Document Control program at the Reno location

QA Lab Supervisor

• Nov 2013 - Jan 2016

Assisted in successful completion of SQF Certification Level 3 Established and maintained Specification Books for products produced. Created & Edited SOP Ordered all materials and equipment for labs Assisted in all audits from customers & all 3rd parties as applied to Quality Assurance Review raw material for compliance to specifications Prepared Certificate of Analysis for Customers Communicate with vendors for Supplier Notification Reports concerning raw materials… Show more Assisted in successful completion of SQF Certification Level 3 Established and maintained Specification Books for products produced. Created & Edited SOP Ordered all materials and equipment for labs Assisted in all audits from customers & all 3rd parties as applied to Quality Assurance Review raw material for compliance to specifications Prepared Certificate of Analysis for Customers Communicate with vendors for Supplier Notification Reports concerning raw materials, packaging or ingredient. Work on Hold program Work on Food Safety, GMP & HACCP programs and training Supervise Laboratory personnel Performed tests on samples Trained technicians Maintain detailed file and organization systems Troubleshoot equipment and process problems Standardize, calibrate, use and maintain equipment

Quality Control Microbiology/Physical Labs Lead

• Nov 2012 - Apr 2013

Accomplishments Successful start up of Microbiology lab Successful Start up of Physical Lab Lead for all Quality personnel for Start up until supervisors hired for their department Accountability Ordered all materials and equipment for both labs Trained techs for both Microbiology and Physical Lab Worked on implementing deviation program Deviation Investigations Wrote SOP's Completed Baseline cleaning study of entire production area Responsible for accurately… Show more Accomplishments Successful start up of Microbiology lab Successful Start up of Physical Lab Lead for all Quality personnel for Start up until supervisors hired for their department Accountability Ordered all materials and equipment for both labs Trained techs for both Microbiology and Physical Lab Worked on implementing deviation program Deviation Investigations Wrote SOP's Completed Baseline cleaning study of entire production area Responsible for accurately recording data Standardize, calibrate, use and maintain pH meters, Oven, Water Baths, scales, FT-IR, moisture analyzer, bulk tap machine, Solaris. Responsible for installation of major equipment Ran tests in Microbiology lab as needed including Bacteria, Salmonella, Listeria, TVC, and more. Ran tests in Physical lab as needed including Bulk tap, moisture analysis, disintegration, hardness, friability and more. Show less Accomplishments Successful start up of Microbiology lab Successful Start up of Physical Lab Lead for all Quality personnel for Start up until supervisors hired for their department Accountability Ordered all materials and equipment for both labs Trained techs for both Microbiology and Physical Lab Worked on implementing deviation program Deviation Investigations Wrote SOP's Completed Baseline cleaning study of entire production area Responsible for accurately… Show more Accomplishments Successful start up of Microbiology lab Successful Start up of Physical Lab Lead for all Quality personnel for Start up until supervisors hired for their department Accountability Ordered all materials and equipment for both labs Trained techs for both Microbiology and Physical Lab Worked on implementing deviation program Deviation Investigations Wrote SOP's Completed Baseline cleaning study of entire production area Responsible for accurately recording data Standardize, calibrate, use and maintain pH meters, Oven, Water Baths, scales, FT-IR, moisture analyzer, bulk tap machine, Solaris. Responsible for installation of major equipment Ran tests in Microbiology lab as needed including Bacteria, Salmonella, Listeria, TVC, and more. Ran tests in Physical lab as needed including Bulk tap, moisture analysis, disintegration, hardness, friability and more. Show less

Quality Control

• Jan 2006 - May 2012

Accomplishments Developed the Sample Retention Program Maintained storage and disposal of hazardous lab waste material Managed all audits from customers as applied to Quality Control Laboratory Accountabilities Coordinated sampling and testing requirements of raw materials and finish products Verified raw materials and finished products meet specification Performed physical, analytical and microbial testing per QC procedures Maintained storage and disposal of… Show more Accomplishments Developed the Sample Retention Program Maintained storage and disposal of hazardous lab waste material Managed all audits from customers as applied to Quality Control Laboratory Accountabilities Coordinated sampling and testing requirements of raw materials and finish products Verified raw materials and finished products meet specification Performed physical, analytical and microbial testing per QC procedures Maintained storage and disposal of hazardous lab waste material Prepared Certificate of Analysis for Customers Responsible for accurately recording data Standardize, calibrate, use and maintain pH meters, Gas Chronometer, Oven, Water Baths, Viscometer, Bubble Viscometer, Centrifuge Maintained detailed record systems Order materials in a timely manner Operate computers for process control, data entry and tracking Responsible for the training program Show less Accomplishments Developed the Sample Retention Program Maintained storage and disposal of hazardous lab waste material Managed all audits from customers as applied to Quality Control Laboratory Accountabilities Coordinated sampling and testing requirements of raw materials and finish products Verified raw materials and finished products meet specification Performed physical, analytical and microbial testing per QC procedures Maintained storage and disposal of… Show more Accomplishments Developed the Sample Retention Program Maintained storage and disposal of hazardous lab waste material Managed all audits from customers as applied to Quality Control Laboratory Accountabilities Coordinated sampling and testing requirements of raw materials and finish products Verified raw materials and finished products meet specification Performed physical, analytical and microbial testing per QC procedures Maintained storage and disposal of hazardous lab waste material Prepared Certificate of Analysis for Customers Responsible for accurately recording data Standardize, calibrate, use and maintain pH meters, Gas Chronometer, Oven, Water Baths, Viscometer, Bubble Viscometer, Centrifuge Maintained detailed record systems Order materials in a timely manner Operate computers for process control, data entry and tracking Responsible for the training program Show less

Administrative Assistant

• Oct 2004 - Jan 2006

Manufacturing Technician II

• Nov 2002 - May 2004

Accomplishments Create and Revise Batch Production Record and SOP Review recorded information for accuracy and completion in completed Batch Production Records, and other documentation Accountabilities Operate process control systems Responsible for accurately recording processing data Execution of biopharmaceutical manufacturing processes in fermentation of Cell Culture Execute Integrity Tests, manually or with the Sartocheck system Aseptic execution of… Show more Accomplishments Create and Revise Batch Production Record and SOP Review recorded information for accuracy and completion in completed Batch Production Records, and other documentation Accountabilities Operate process control systems Responsible for accurately recording processing data Execution of biopharmaceutical manufacturing processes in fermentation of Cell Culture Execute Integrity Tests, manually or with the Sartocheck system Aseptic execution of biopharmaceutical cell culture scale up Clean, set-up, integrity test, sterilize, operate, sample and monitor shaker flasks, spinners flasks and fermentors Execution of Cell culture UF/DF Harvest Follow current GMP, GLP & Standard Operating Procedures in a highly regulated environment Troubleshoot equipment and process problems SME for Nova Bioprofile Analyzer Standardize, calibrate, use and maintain pH meter, Conductivity meter, Ektochem chemistry system, Osmometer, Centrifuge Order controlled materials in a timely manner for production run Maintain controlled materials inventory Research and order large capital equipment and parts through Oracle control system Cross Trained on Aseptic Fill Operate computers for process control and data entry

Manufacturing Technician

• Jun 2000 - Oct 2002

Accomplishments Troubleshoot equipment and process problems Execution of biopharmaceutical manufacturing Cell culture processes Accountabilities Operate, sample and monitor 80L, 400L, 2000L, 12000L fermentors Sample and monitor Bioreactor Execution of UF/DF Harvests Execution of Tangential Flow Filtration Troubleshoot equipment and process problems Follow current GMP & Standard Operating Procedures in a highly regulated environment Completing assigned tasks… Show more Accomplishments Troubleshoot equipment and process problems Execution of biopharmaceutical manufacturing Cell culture processes Accountabilities Operate, sample and monitor 80L, 400L, 2000L, 12000L fermentors Sample and monitor Bioreactor Execution of UF/DF Harvests Execution of Tangential Flow Filtration Troubleshoot equipment and process problems Follow current GMP & Standard Operating Procedures in a highly regulated environment Completing assigned tasks that include preparing media and solutions, cleaning and sterilizing vessels Responsible for accurately recording processing data and reviewing recorded information for accuracy and completion Operate computers for process control and data entry On-the-job trainer for new and incoming technicians on my shift SME for Nova Bioprofile

Instructional Assistant

• Aug 1999 - Jun 2001

Accomplishments Teach students how to do detailed titration, plankton and benthic counts Maintained class records Accountabilities Teach students how to determine turbidity, phosphate, nitrate and silica using the La Motte Digital Spectrophotometer Tutored students in basic concepts of Chemistry, Physics, Geology and Biology as these subjects pertain to Oceanography Accomplishments Teach students how to do detailed titration, plankton and benthic counts Maintained class records Accountabilities Teach students how to determine turbidity, phosphate, nitrate and silica using the La Motte Digital Spectrophotometer Tutored students in basic concepts of Chemistry, Physics, Geology and Biology as these subjects pertain to Oceanography