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cGMP Lead

Company: Big Sky Scientific
Location: Great Falls
Posted on: August 8, 2019

Job Description:

Job description:We have an outstanding onsite cGMP lead! This role will be full time.---- The ideal candidate must be able to help lead a 'ground-up' extraction facility to become cGMP certified.--The candidate must embody Big Sky Scientific values: integrity, dedicated, fun and agile.--Applied experience is necessary.--Embodied Values:1. Take Action2. Do What We Say3. Lead By Example4. Do The Right Thing5. Practice Stewardship Responsibilities:-- Extensive knowledge and experience involving all aspects of cGMP & industrial hemp ethanol extraction: 1.) hemp; 2.) ethanol extraction; 3.) winterization; 4.) decarboxylation; & 5.) distillation -- Determine efficient processes to become cGMP certified via 21 CFR compliance: 1.) clean & hygienic area; 2.) controlled cross-contamination; 3.) critical processes are validated; 4.) any changes must be evaluated; 5.) instructions and procedures via good documentation practices; 6.) trained operators; 7.) traceability and adherence too; 8.) distribution chain has minimized quality risks; 9.) system in place for recalls; and a 10.) system in place to respond to complaints-- -- Prepare and manage weekly updates to the execuitve team on progress -- Advise on GLP certification as well -- Oversee and assist with the setup and production of extraction lab expansion -- Knowledge of federal & specific state CBD & industrial hemp rules and regulationsBasic Qualifications:-- At minimum a bachelor's degree in: industrial engineering, operational management or chemical engineer, with 5+ years of experience in applicable industry;-- Experience with direct contact with FDA

Keywords: Big Sky Scientific, Great Falls , cGMP Lead, Other , Great Falls, Montana

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