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Quality Regulatory Compliance Specialist

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full-time

Posted on:

Location Type: Office

Location: Grand RapidsMissouriUnited States

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About the role

  • Responsible for compliance with the requirements of 21CFR Parts 110/111 and 210/211
  • Works closely with the Quality Managers and other internal department managers and supervisors
  • Ensures Quality Assurance oversight, reviews approvals and releases all assigned products
  • Collaborates with Praxis Leadership and partners to educate, audit and enforce applicable cGMPs
  • Manages Internal and External Audit programs
  • Responsible for operational and facility integrity relating to food safety, pest control, sanitation
  • Develops quality assurance plans by conducting hazard analyses; identifying critical control points
  • Monitors and ensures compliance of facility AIR and WATER quality performance testing

Requirements

  • 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
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality System ManagementcGMPhazard analysiscritical control pointscompliance testingaudit managementfacility integrityfood safetysanitation
Soft Skills
collaborationsupervisioncommunicationleadership