· Maintain QC written procedures including 1) responsibilities of the Quality Control operation compliant with 111.103, 2) conducting a material review, 3) making a disposition decision, and 3) approving or rejecting any reprocessing
· Review and approve documentation for supplier qualification (contract manufacturer) per 21 CFR Part 117 Subpart G-Supply Chain Programs including reviewing and approving verification activities (audit, records review, sampling and testing, a combination or these three, or other to be determined)
· Review and approve justification for why results of testing ensure finished batch meets specifications
· Determining if all manufacturing specifications are met
· Review and approval all lab control processes including test and examination.
· Ensure all testing and examinations are conducted
· Ensure raw materials testing for identity and maintain records for identity testing.
· Review documentation for material reviews and disposition determinations. Determine corrective actions to be taken
· Ensure calibration of equipment used for manufacturing of Zilis products including review and approve processes for calibration and periodic review of calibration records
· Ensure sanitation practices at the contract manufacturer are appropriate for the safe and food/dietary supplements. Periodic verification activities to ensure these practices are followed to protect against cross contamination of the finished product including pathogens, allergens, or metal fragments
· Determine if all component and packaging specifications are met and make disposition decision prior to use in manufacturing
· Release labels and packing from quarantine before use
· Approve or reject reprocessing
· Review and approve master manufacturing records, batch records, and production related records to support full manufacturing history
· Review packaging records
· Establish and implement written procedures for QC operations
· Education level: Bachelor's degree
· Experience: At least one to two years related experience and/or training, preferably in Dietary Supplement, Food, or Pharmaceutical or CBD industry in a quality control or quality assurance function.
· Preferred certifications/completed coursework: PCQI, HACCP, FSVP, Audit Training
Working knowledge of FSMA, 21 CFR 111, and 21 CFR 117,
Experience with customer and regulatory audits/inspections; preferred: qualified auditor
Experience preparing and approving SOPs to support the Quality Management systems preferred.
Excellent verbal and written communications and presentations skills, including effectiveness in conducting or participating in meetings, speaking before audiences, or providing training.
Ability to multi-task several initiatives simultaneously while adhering to aggressive timelines.
Job Type: Full-time
Pay: $50,000.00 - $100,000.00 per year
Paid time off
Monday to Friday
Quality Control: 1 year (Required)
Dietary Supplement, Food, or Pharmaceutical or CBD industry: 1 year (Required)
preparing and approving SOPs: 1 year (Preferred)
FSMA, 21 CFR 111, and 21 CFR 117: 1 year (Required)
Customer and Regulatory audits/inspections: 1 year (Preferred)
PCQI, HACCP, FSVP, Audit Training (Preferred)
United States (Required)
Temporarily due to COVID-19
Quality Control Manager
Reports To: Hemp Operations > Director of Scientific Research and Development