Guy Johnsen Email & Phone Number

Springville, Utah, United States

1. Document Control Specialista. I know how to complete Product Descriptions and Master Manufacturing Records for new or revised finished products.b. I have experience using the Expandable ERP and the DataNinja MES systemsc. I know how to create DCRs and Document Revisions using the document control system AssurX.d. I can work with sales and external customer to ensure the completion and retention of Quality Agreements.e. I conduct and train new hire employees each week on the cGMPs (21 CFR parts 110, 111) as well as Food Defense, Food Safety Awareness, and Good Documentation Practices.f. I can work alone or with organizations to update company SOPs or Forms. I can also create forms, procedures, trackers, and reports from scratch.g. I know how to take directions from managers and then write work instructions for those processes that other employees can then follow.h. I know how to use technology, systems, and digitalization to improve quality processes and documentation.

South Jordan, Utah, United States

1. Training Administratora. I created prescriptive rules, courses, classes, curriculum, certifications, and training reports for effectiveness checks and audits.b. Ensured training compliance with regulatory requirements, standards, and directives for trainingc. Managed all employee training records according to procedures and GDP in LMS.d. Created and managed Ultradent Quality Training Requirements based on job rules and descriptions.e. Utilized ticketing system to track all training requests, changes, issues, and reports.f. I was instrumental in identifying and resolving training problems and issues.2. Training Coordinatora. Collaborated with Operations and Quality organizations to assess training need and develop training programs.b. Identify training gaps, risks, and opportunities.c. Periodically monitored processed and procedures to ensure organizations training courses and certification were accurated. Flexible approach to training creation and instructional design (i.e. ADDIE, Backward Design, Iterative Design) while maintaining excellent communication and organizational skills.e. Used Adobe Captivate to create and publish training content (i.e. SCORMs) for f. Created, revised, and updated training procedures and processes within Microsoft office and Adobe DC Pro.g. Ensured proper changes to training documents and procedures in the Agile document management system.h. Created and managed Microsoft Power BI reports for training analytics and semiannual management review.i. Created and taught cGMP training to all new employee during new hire orientation.j. Assisted HR with onboarding employees to the Saba LMS.3. Documents of External Origin Administratora. Scheduled and conducted DEO meetings for quality assurance and regulatory affairs.b. Ensured organization SMEs received and completed DEO impact assessment forms.c. Created DEO impact assessment form final reports for retention in Agile document management system.

South Jordan, Utah

1. Document Controla. I participated in OLM Audit by creating and controlling audit binders, creating and indexing procedures for management, and acted as scribe for creating audit transcripts.b. I wrote procedures and checklists for proper lifecycle management of all controlled documents.c. I facilitated in creation, review, approval, and release all OLM organizations changes in the Agile document management system.d. Act as a technical writer or editor when needed on OLM documentation.e. I create document control metrics in Power BI and Power Point for Quality Council meetingsf. Keep all Changes up-to-date and monitor their progress daily.g. I created and taught all OLM new hire employees cGMP and the quality documentation requirements.2. Training Specialista. I helped in the validation and implementation of the Saba LMS for OLM.b. I managed all OLM training record in the Saba LMS.c. I worked with OLM organizations to create training content using Adobe Captivate and then assign employee the training within the Saba LMSd. Maintain, track, and monitor organization training requirementse. Create Power BI training reports for Quality Council meetings and monitored training compliancy for all OLM organizations.f. I ensured the proper creation, revision, and obsoletion of training content and learning events.g. Create and managed training records and reports for OLM management and for internal audits.

South Jordan, Utah

1. Environmental Monitoringa. Support manufacturing by performing process control through environmental monitoring (EM) on water generation system, raw material sampling, compressed gas system, HEPA Filtration system, Particulate Air Monitoring, Viable Air sampling, and cleaning validation/verification sampling. b. Provided Ultradent organizations with EM Alert/Action notifications, generate EM reports, maintain EM equipment, and investigated EM events.c. Revised EM and Microbiology forms and procedures.

1. Chemistry wet laba. Followed quality control procedures in testing raw materials, in-process bulk chemicals, and finished products.b. Followed good laboratory practices and good documentation practices for all laboratory records and data.c. Cleaned, maintained, and calibrated analytical equipment.d. Worked with outside laboratories to send raw materials and finished goods for testing.e. Investigate and document testing results quality events including, OOSs, OOTs, and NCRs.

Greater Salt Lake City Area

·Processing new production and raw samples.·Managed sample transfer time frames according to methods used.·Powder media production, validation, pH, positive control testing.·Maintained laboratory notebooks and documentation controlled.·Water and environmental sample assays.·Maintained laboratory equipment and lab cleaning schedules.·Wrote SOPs and assisted with procedure creation and documentation.·Maintained positive controlled microorganisms.

Seattle

•Lead investigation into cause of OOS issue of chocolate production line•Microbial Testing of chocolate milk samples utilizing AOAC methods•Assayed raw and finished milk products for TAPC and Coliforms•Utilized GLP in equipment maintenance and document traceability

Salem, Utah

·Assayed and qualified raw material, in-procces, and finished products for release tomanufacturing and market.·Assayed dietary supplements, foods, and cosmetic products utilizing compendialmethods.·Manufactured and qualified all laboratory media via sterility, aseptic technique, andgrowth promoting validations.·Utilized GMP/GLP standards in equipment calibration, document control, andtraceability.·Antimicrobial Effectiveness Testing (USP, CFTA, AOAC).·Utilized TAPC, TYMC, and pathogenic organism absence screening.·OOS/CAPA Investigations-identified unknown organisms and associated failurecause(s).

Bachelor Of Science (B.S.), Bio-Environmental Science

RELEVANT COURSEWORK Soil Microbiology Environmental Microbiology Biology Soil Science Organic chemistry Plant Pathology Environmental.

Associate Of Science - As, Biology, General

Activities and Societies: SGA

Associate Of Science (A.S.), Biology