Responsible for leading the day to day operations of the group pertaining to investigation of deviations, and the subsequent documentation of the deviation, root cause analysis, CAPA, and impact assessment of the event. Responsible for implementing procedures to assure compliance with EU, USDA, and corporate requirements; and ensuring final investigation reports meet regulatory and BIAH requirements.- Coordinates the overall operation of the group. Prioritizes work, resolves issues, develops and institutes quality and efficiency improvements, and conducts performance reviews. - Maintains key performance indicators for operational investigations.- Maintains personal knowledge skills in the awareness of current regulatory and corporate practices.- Review and approve laboratory and manufacturing investigations to ensure compliance with BIAH policies and applicable regulatory guidance. - Coordinate investigations across all functions within operations, ensure effective root cause analysis, and develop corrective and preventive actions for associated events relating to biological production operations and associated quality systems. - Ensure timely completion of investigations per procedures, and the implementation and completion of corrective and preventive actions.

Conducts investigations into complex and abstract deviation events for products produced at BIAH.Performs the investigation of deviations for somewhat complex products manufactured at BIAH toidentify the root cause, impact assessment, and CAPA to assess quality requirements to comply withUSDA, EU, FDA, or other GMP regulatory requirements and proposes disposition of the product.- May be assigned to or assist with investigational reports not associated local deviations such asTPMQ, complaint, or other facility investigations. - Participates on investigation related project teams to evaluate events, which are investigated.- Completes maintenance of systems associated with the investigation function.- Produces the technical investigation report detailing the findings and assessment of theinvestigation under some direct supervision.- Investigation reports and impact assessments are complete and compliant with regulations. - Submits data for weekly/monthly KPI reports.- Serve lead as a QA representative and SME on assigned internal and external project teams (changecontrols, process improvements, technology transfer, training, business process excellence,electronic system deployment) as a technical/compliance resource to solve quality related issues.- Communicate new requirements/perform training with QA Investigation team to assure all time-lines are met resulting in successful project completion and new product launches.- Assist with internal, regulatory or corporate audits to ensure compliance with domestic andinternational regulations, quality requirements and guidance documents. - Assist with audit responses and completion of assigned CAPAs by target due dates. times.- Influences as a technical resource and departmental SME for quality related questions or topics- Serves as a deputy to the QA Investigations Leader in the event of his/her absence.

 Method development and validation (Chemical and Biological) –Chromatography, Biochemical Assays, ELISA, microbial monitoring Preventative Controls Qualified Individual (PCQI) Technical writing, process development, and logging information SOP approval and generation In-house product testing Coordinates third party testing of products/ingredients Subject Matter Expert(SME) for scientific, production, and quality matters. Ensures that BioZyme is in compliance with International regulatory concerns from a product quality/safety perspective. Work with company insurance providers to keep up to date on industrypractices regarding company quality and safety.

Primary Responsibilities:●Manage the Quality Team●Preventative Controls Qualified Individual (PCQI)●Technical writing, process development, and logging information●Tracks and reviews Change Control Documentation●SOP approval and generation●Root cause analysis of Internal and Corrective Actions●Employee training of pertinent SOPs and their revisions.●Internal Audits - Reviewing facilities with both a quality and a safety focus. Relay information to managers as needed.●In-house product testing●Coordinates third party testing of products/ingredients●Work with state and third party auditors to ensure the company complies with all pertinent regulations.●Ensures that BioZyme is in compliance with International regulatory concerns from a product quality/safety perspective.●Work with company insurance providers to keep up to date on industry practices regarding company quality and safety.Secondary Responsibilities:●Biochemistry - enzymes●Instrumental methods - Proximate analysis and GC/FID●New Product Development - Liquids, Gels, and Pastes

Primary Responsibilities:●Instrument operation, maintenance, and method development●Technical writing, primarily SOPs and Form/Logbook generation; such as Change Control forms, Root Cause analysis, and training of personnel in SOPs and their revisions.●Lab Manager●Product Development●QA and QC●Fermentation and downstream processing●In vitro developmentOther responsibilities:●Provides technical support for production/marketing●Manufacture of specialty products.●Troubleshooting inventory issues (Through a strange twist of fate I ended up helping to set up our electronic inventory system in the production facility.)

Lab Instructor for Chemistry 101, Introduction to ChemistryLab Instructor for Chemistry 104, Fundamentals of Chemistry

Responsibilities:●Instrumental operation and troubleshooting●Instrumental maintenance●Solution preparation●Development of extraction techniques for different organic compounds●Aid clients with scientific documentation preparation●Technical writing, primarily SOPs