This role is a member of the quality control team and is responsible for the day to day function of the traceability program. The Traceability Coordinator demonstrates a commitment to cGMP, quality and GDP to ensure conformance to standard practices.
Reports directly to the Quality Control Manager
- Receive batch folders prior to release to production, verify folder accuracy against bill of materials and pre-production folder checklist. Communicate the release of batch folders to production. Return any inaccurate or incomplete folders to Document Control Manager.
- Work with production supervision and quality control in order to resolve documentation errors.
- Input raw material and packaging receiving forms into traceability databases and verify for accuracy.
- Combine completed lab testing documentation with raw material receiving form. Communicate the release of quarantined raw material to warehouse management.
- Release the quarantine of finished goods for shipment in accordance with lab testing documentation and batch production record folder close-out. Document actual and theoretical yield of completed batches.
- Inspect finished goods folders and verify for accuracy according to GDP policies.
- Using mixing and partials sheets, log raw material and packaging lots and quantities into traceability excel spreadsheets. Verify accuracy and completeness in accordance with the bill of materials.
- Assist in the maintenance of the folder/production tracking excel spreadsheet, documenting date of production, folder errors, and date of folder closing for each batch.
- Maintain the entirety of the traceability excel spreadsheet and continuously improve traceability process under direction of Senior Quality Control Manager.
- Complete other duties or task as assigned by management.
- An Associate’s Degree in Business or a Financial Field and 2+ years in data entry and maintenance environment.
- A self-starter with the ability to work with limited supervision.
- Proficient in Excel and Word.
- 1+ year(s) in food manufacturing environment, preferably within nutritional supplements.
- Knowledge of 21 CFR 111 and GDP policies.
- Attendance and punctuality are a must as the Traceability Coordinator job function is vital to the release of finished goods.
- Must have a positive attitude in order to work in a team oriented environment.
- Good documentation and communication skills, organized, attention to details, self-starter and team worker.
- This position is from 8:30am to 5:00pm each week day with additional work including off shift and / or weekend work as required.
- A large part of this job is spent working in an office which includes utilizing Microsoft Excel and Word and maintaining detailed, accurate, up to date files. Some time spent working with documents on the factory floor.