Address
Form of workJob Description
About the Job:
Salud Natural Enterprises (SNE) is a family owned dietary supplement manufacturer looking for an individual to fill the open position of QA manager. This individual will work on a multi-disciplined team (with materials management and production management) but be the point lead on all QA issues. Experience with FDA audits not required but highly desired .
Day to day operations
· Sample all incoming materials according to establish sampling plans and arrange timely testing by approved Third party Laboratories.
· Perform incoming visual ID testing of Commodity Printed Specifications and Non-Commodity Printed Specifications
· Approve and issue blank BPR’s to production
· Ensure applicable production procedures and BPR are followed
· Confirm work orders are properly dispensed
· Confirm line-clearance activities
· Dispense fully approved printed commodities to production
· Ensure in-process QC checks are performed and that required representative samples are collected
· Ensure any failures to meet in-process and finished specifications
· Ensure that any deviations or EE’s are documented
· Confirm that every BPR is an accurate representation of the Master Batch Record (MBR)
· Confirm that all cGMP’s are properly documented
· Complete batch record review checklists
· Follow the record retention policy to ensure that production records are maintained
Qualifications
· Deep understanding of FDA’s 21 CFR 111 regulations on Dietary Supplements, FSMA (food safety modernization act) and HACCP (hazard analysis critical control points)
· Have experience working with MS Word, Excel and Outlook
· Solid communication skills
· Experience in change control and general technical knowledge of testing desired
· Able to occasionally lift a maximum of 50Ibs with assistance
· Fluent in English
· Not required but greatly desired if the individual is fluent or able to speak some Spanish
· Not required but beneficial if applicant if applicant has a science, biology or engineering degree
