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Quality Assurance Manager
2 months ago
About the Job:
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