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Provide ongoing support by helping to create new documents, reviewing and revising existing documents, and verifying that the documents are aligned with relevant regulations.
- Assist in review of protocols, summary reports (customer complaints), SOPs, and internal specifications to ensure the document is accurate and complete.
- Follows cGMP practices, policies and procedures.
- Perform record reviews of batches supplied by co-manufactures.
- Review certificates of analysis from co-manufactures.
- Help to maintain electronic document management system.
- Provide tracking and trending documentation for customer complaints.
- Assist in review of customer complaints ensuring complaint documents are accurate and complete.
- Create complaint tracking and trending reports; support matrices as required.
- Work with third party call centers to ensure reports are submitted accurately, timely, and are properly closed.
- Process and analyze complaints in accordance with company policies and processes.
- Work with internal departments in the review and approval of label development.
- Assist in the review and ensure labels meet FDA labeling guidelines.
- Provide approved copies of labels art work to co-manufactures as requested.
- QA Documentation Specialist Requirements:
- Preferred Associates Degree or higher in Sciences (Food, Microbiology, Chemistry)
- 1–3 years’ experience in food, dietary supplements or pharmaceuticals
- QA/QC or manufacturing experience
- Knowledge of GMP, FDA trends and guidelines
- Strong computer skills, knowledge of Excel and Word
- HACCP, SOF, HARPC helpful
- Normal office hours 8:00 – 5:00; will consider part time
Company: Cookietree, Inc.
Contact: Craig Sandberg
Position: Food Technician, Full-time
Location: Salt Lake City