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Quality Assurance Compliance Specialist

2 months ago

Spokane, Washington, United States Jubilant HollisterStier LLC Full time
Job Description

Jubilant HollisterStier LLC, a leading pharmaceutical company, is seeking a highly skilled Quality Assurance Compliance Specialist to join our team.

Key Responsibilities
  • Support the company's Deviations, Corrective and Preventive Action (CAPA) program by conducting thorough root cause analyses of deviations and vendor complaints.
  • Ensure product compliance and safety by reviewing deviations, investigations, and CAPAs to ensure accuracy, consistency, and compliance with applicable SOPs, policies, and regulations.
  • Facilitate deviation investigation and resolution, assess product impact, and complete final assessments for QA Management and client review.
  • Enter data into the corporate RCA and CAPA database to support quality systems and processes.
  • Provide oversight of investigational RCA group activities, including meeting preparation, publishing meeting minutes, and follow-up on agreed-upon activities and tasks.
  • Interface with management and responsible individuals to ensure task completion on or before established due dates.
  • Support quality systems, processes, and procedures to ensure compliance and product quality and safety.
  • Assist QA and department management in implementing corrective actions stemming from deviations, audits, or regulatory inspections.
  • Provide deviation and CAPA metrics as needed for management review of system data.
Requirements
  • Associate's degree in Biology, Chemistry, or a related field, or 5 years of experience in lieu of an associate's degree.
  • Minimum 2 years of experience in the pharmaceutical industry, with a bachelor's degree in a science field desired.
  • Experience with technical writing and regulatory compliance.