Corporate Compliance Warehouse Quality Systems & Licensure Consultant
Alta Resources is Hiring!
Alta Resources in Neenah, WI is searching for an independent consultant to close out a special, transactional project to make a portion of its fulfillment center located in Neenah FDA-Compliant for warehousing and distribution of OTC Medical Devices and OTC Drugs.
Such a consultant will assist Alta with cGMP Warehouse Quality Systems & Licensure Assistance, (Neenah, WI). We are looking for a SME that has strong expertise in this area inclusive of QMP and 3PL licensing. We are at the point that all required SOPs (about 13) and Quality Manual need a review by such an expert.
This project is governed heavily by 21CFR205.50.
Alta Resources hopes to hire such a consultant to provide the following services:
- Assist Alta Resources to finalize a Quality Management System (QMS) that will meet the US guidelines and be compliant for distribution of: Over-the-Counter (OTC) drugs and lower-risk Medical Devices (i.e. Class 1).
- Assist with licensure procedure for 3PL/distribution activities for distribution of: OTC drugs and lower-risk Medical Devices (i.e. Class 1) for three entities (Federal, Texas & Minnesota).
The QMS will focus on the Alta Resource operations of: Order Entry, Inventory Management/Warehouse operations, and Shipping (Neenah, WI).
We expect this project to take approximately 40 – 80 hours of review and editing.
A second phase may include training on these documents and related processes to our team governed by it.
Any interested consultants will have the chance to review and scope out this project prior to any commitment by Alta or consultant. There is a need to start this project immediately so availability is of importance.
7+ years of experience in FDA GMP Warehouse Quality Systems
Successful history of applying for and obtaining licenses for 3PL/distribution activities for distribution of: OTC drugs and lower-risk Medical Devices (i.e. Class 1) at federal and state level
Ability to draft and refine SOPs and quality Manual for a FDA GMP Warehouse Quality Systems
Good communication skills
- Pay Type Hourly
- Neenah, WI, 120 N Commercial St, Neenah, Wisconsin, United States of America