· Develops and implements the cannabis focused quality system within the One Innovation Labs quality system.
· Develops all quality documentation for cannabis products.
· Acts as key customer contact for quality-to-quality relationships.
· Provides cannabis quality expertise, rationale, and direction to the Director of Quality; assists sites in achieving overall safety and quality of products; manages risk assessment for non-compliant product where required.
· Assures proper processes and procedures are executed to maintain regulatory and certification compliance.
· Manages external third-party laboratory relationships.
· Provides reports, risk assessments, statistical analyses, and continuous improvements to aid the Director of Quality in overall quality improvement efforts.
· Inspect and approve cannabis rooms, lines, and equipment prior to use by manufacturing and R&D personnel.
· Approve components for in-process cannabis operations.
· Monitor cannabis manufacturing areas for compliance with internal SOPs, cGMPs, and FDA regulations.
· Document all cannabis work activity in appropriate batch records, forms, and logs to ensure accuracy and compliance.
· Sample cannabis in-process items and finished products; Perform required inspections and testing on in-process items and finished products; Process and distribute samples to different departments; Review records for cGMP compliance for accuracy and thoroughness.
· Inform Director of Quality of problems, failures, and deviations from established internal and regulatory standards.
· Apply disposition sticker to cannabis components and in-process material.
· Issue QA Alerts whenever any questionable component, in-process material, or product is identified at any stage of production or storage.
· Assist with employee training as relevant by procedures.
· Assist in controlled document revisions and approvals in conjunction with the Director of Quality.
· Other responsibilities as assigned by the Director of Quality.
· Technically proficient and able to communicate through to customer level.
· Highly organized/proven multi-tasker.
· Self-starter/highly motivated.
· Proven leadership skills.
· Proven problem solver that concentrates on driving solutions.
· Collaborative across all departments.
· Good interpersonal skills.
· Effective analytical skills.
· Ability to thrive in a fast-paced environment.
· Capability of initiating and managing change.
· Experience interfacing with regulatory authorities, affairs, trade groups and customers.
· Regularly required to stand for more than one hour at a time; occasionally lifts and carries objects weighing up to 50 pounds.
Job Type: Full-time
Pay: $55,000.00 per year
- FDA regulations as related to food/dietary supplements and cannabis.