- Minimum 3years' experience Quality Management
- Knowledgeable of FDA and cGMP regulations and guidance, as it relates to the cryogenic and packaged gas industry.
- Willingness to travel 30% nationally.
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UIG - Quality Assurance Supervisor - Bethlehem, United States - Universal Industrial Gases, LLC
Description
Job Details
Division: Universal Industrial Gases, LLC
Location: Bethlehem, PA, United States
Other Available Locations: Arkansas; Kentucky; South Carolina; West Virginia
Basic Job Functions:
Universal Industrial Gases, LLC. (UIG) is a wholly owned subsidiary of Nucor and a well-established, global engineer, constructor, supplier and operator of air separation plants and related equipment and services, based in Bethlehem, PA. UIG owns and operates production plants across the USA which supply both Nucor steel sites and third-party clients 24/7 with tonnage quantities of oxygen, nitrogen and argon as well as exporting liquid cryogenic products by road tanker.
UIG is seeking a Quality Assurance Supervisor to proactively lead the industrial, medical and food gas compliance program for all UIG production facilities as well as provide quality input support to the UIG project, engineering, construction, and commercial teams. This position will be the key point of contact with Federal and State medical gas compliance, including necessary licensing for the operational facilities. This position could be based in Bethlehem, PA, or potentially in a UIG facility in Kentucky, Arkansas or South Carolina.
Requirements:
• Oversee the generation and review of documents used in good manufacturing practices.
• QA audit leader/Head of Quality Control Unit (QCU)
• Lead investigation and resolve potential product quality issues to improve efficiency.
• Supervise the implementation and maintenance of Quality Management Systems (QMS) and programs, overseeing quality assurance initiatives.
• Lead quality systems documentation of records, forms, manuals, and instructions.
• Oversee personnel conducting audits and testing products for compliance with applicable quality standards, specifications, policies, and regulations.
• Collaborate cross functionally to lead quality assurance training and communicate best practices.
• Create, develop, and implement Standard Operating Procedures (SOPs), work instructions, department policies and protocols, applicable to pertinent regulations from ISO, FDA, and other regulatory agencies.
• Review and critique the Quality Assurance program to ensure its components such as training, internal and external audits are completed in accordance with SOPs.
• Fulfill supervisory responsibilities in accordance with organizational policy and applicable laws.
• Key team member in vendor quality program.
• Keep up to date on changing regulatory environment, including maintaining communications with CGA/EIGA guidance.
• Lead and maintain process and computer validation efforts in accordance with cGMP and industry best practices.
• Maintain federal and state regulatory medical and food gas licensing.
Safety is the most important part of all jobs within Nucor; therefore, candidates must be able to demonstrate the ability to initiate, lead, and uphold safety policies, practices, procedures, and housekeeping standards at all times.
Minimum Qualifications:
Preferred Qualifications:
Bachelor's degree in a technical field, or 5 years' experience in a medical gas manufacturing environment or similar role in industrial gas or related industries.
