Quality Control Manager

Dallas, Texas | Full-Time

Job viewed11,396times

Responsibilities and Duties:

· 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

 

Qualifications:

· 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

  • Specific skills.
  • 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

Benefits:

  • Dental insurance
  • Employee discount
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • Monday to Friday

Experience:

  • 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)

Education:

  • Bachelor's (Required)

License:

  • PCQI, HACCP, FSVP, Audit Training (Preferred)

Work authorization:

  • United States (Required)

Company's website:

  • www.zilis.com

Work Remotely:

  • Temporarily due to COVID-19

Zilis LLC

Quality Control Manager

Reports To: Hemp Operations > Director of Scientific Research and Development

Job Location: Dallas/Ft. Worth Area

  • Salary
  • Career Level
  • Degree
  • Experience
  • Job Type
  • Attractive
  • Full-Time

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