Quality Regulatory Compliance Specialist

Responsible for compliance with the requirements of 21CFR Parts 110/111 and 210/211. This position works closely with the Quality Managers and other internal department managers and supervisors at Praxis to ensure Quality Assurance oversite, reviews approvals and releases all assigned products throughout the life cycle of the batch from receipt of PO to reporting PO. This position collaborates with Praxis Leadership and partners to educate, audit and enforce all applicable cGMPs, customer requirements, and Praxis QMS documents. This position works with all supervision and employees to ensure that cGMPs and Praxis SOPs, policies and work instructions are being followed.

• Manages the content and executional effectiveness of the QA Programs, Systems and compliance with all regulatory requirements associated with Praxis.
• Ensures all Regulatory licensing is maintained, current and compliant per required standards.
• Manages Internal and External Audit programs.
• Responsible for operational and facility integrity they relate to facility food safety, pest control, sanitation, cleaning validation and environmental monitoring. Works with company leaders and employees to ensure cGMP, CFR 110, CFR 211 and Praxis Quality Management System compliance.
• Responsible for internal Quality Audits and Supplier Audits.
• Manages regulatory filing for Praxis
• Ensures that Food Safety, production process, cleaning and general Sanitation procedures are established and performed as planned and necessary.
• Manages Food Defense Plan, including Allergen control and employee education. Establishes and monitors CCPs (critical control points) for HACCP.
• Oversees all cleaning, sanitation and environmental monitoring (swabbing) activities – to include communication with partner departments and customers. Improves processes where necessary.
• Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
• Manages Pest Control programs, processes, reporting, records, corrective/preventive actions, and approved contractors (to include their selection and performance review).
• Ensures insect lights and glue boards are maintained, as directed.
• Monitors REES system for temperature and humidity performance vs. specified ranges and customer requirements. Takes necessary corrective and/or preventive actions.
• Monitors and ensures compliance of facility AIR and WATER quality performance testing (and/or vendors), according to Preventive Maintenance schedule.
• Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints, review and approve deviations and change controls.
• Performs and Manages APR process and compliance.
• Manages the QA review of Facility and Equipment documentation.
• Assist with QA projects.
• Responsible for adherence to all Company policies and procedures.
• Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions.
• Supports a diverse workforce.
• Addresses complaints and problems, elevates to Leadership when needed.
• Ensures proper PPE’s and Safety procedures are followed.
• Instill a sense of quality in through modeled quality behaviors and mindset.
• Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed.
• Responsible for management level of responsibility for reviews and approvals as appropriate.

• Bachelor’s degree, required or equivalent combination.
• 3-5 years Quality experience required.
• Supervision experience preferred.
• Quality System Management (QSM) system design and evaluation, required