Quality Management Specialist
4 weeks ago
CrossFire Group is seeking a highly skilled Quality Management Specialist to join their team. This is a contract position with the possibility of direct hire for the right candidate.
The Quality Management Specialist will provide support to various plants, laboratories, warehouses, and tolling operations that manufacture, test, or handle products regulated by FDA and USDA. The successful candidate will ensure compliance with federal, state, and local regulations, and work closely with Sales, Marketing, and Technical organizations to implement customer requirements into internal operations.
The ideal candidate will have a strong IT focus and be able to digitize quality systems and identify internal and external IT applications within Cellasto. They will also have excellent working knowledge of Excel, PowerPoint, and Visio, with PowerBI experience a plus.
Key Responsibilities- Manage customer complaint process, Non-Conformance Management (NCM), and process with investigators and work with Legal to develop customer letter for product quality NCMS as appropriate.
- Develop updated NCM system training and provide the businesses guidance on trends and opportunities for improvement and insight to customer expectations.
- Provide FDA with NCM review, as needed.
- Work with EHS Management Systems (Responsible Care Management System RCMS)
- Conduct training for the business, customer care, and manufacturing sites concerning QM/EHS related topics
- Advise on the North American Kosher and Halal programs, as appropriate.
- Provide QA oversight for warehousing activities - disposition, relabeling, repackaging and damage material disposal
- Oversee testing and final release of tolled or contract manufactured materials. Includes traveling to tollers during production runs as needed.
- Direct experience writing site and division level processes and procedures (have basic knowledge of laboratory practices at sites)
- Label and technical document approval responsibilities, specifically for contract and tolled materials
- Act as the Manufacturing Site's QA Liaison
- Interact with global for labels on imported products and drive disposition decisions
Required Qualifications
- Bachelors of Science Degree in Engineering, Science or related other technical field
- Minimum 2 years experience in a quality and/or product regulations with the ability to understand and interpret FDA, USDA and other quality and regulatory requirements.
- Strong written and oral communication, analytical, problem solving and organizational skills.
- Ability to work independently and assist internal, as well as external customers
- Receptive to change and innovation with the ability to identify areas for improvement
- Able to multi-task and maintain a professional approach in a fast-paced business environment
- Skilled at working within a multi-functional organization -
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