Quality Assurance Compliance Specialist

5 days ago


Spokane, Washington, United States Jubilant HollisterStier LLC Full time

Job Summary:

Jubilant HollisterStier LLC, a leading pharmaceutical and biopharmaceutical company, is seeking a highly skilled Quality Assurance Compliance Specialist to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring the compliance and safety of our products.

Key Responsibilities:

  • Conduct thorough investigations of deviations and vendor complaints to identify root causes and implement corrective actions.
  • Review and ensure accuracy of data entry into our quality systems, including deviations, CAPAs, and vendor complaint activities.
  • Provide oversight of investigational activities, including preparation of meeting agendas, publishing of 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 the development and implementation of quality systems, processes, and procedures to ensure compliance and product quality and safety.
  • Provide metrics and reports as needed to support management review of system data.

Requirements:

  • Bachelor's degree in a science field, such as biology or chemistry, or equivalent experience.
  • Minimum 2 years of experience in a pharmaceutical or FDA-regulated industry, with a strong understanding of quality assurance principles and regulations.
  • Excellent communication and analytical skills, with the ability to work effectively in a team environment.

Additional Responsibilities for Sr. Associate:

  • Provide investigation training to the quality unit and other departments to ensure consistent handling of investigations.
  • Speak to assigned deviations during regulatory and client audits.
  • Act as the QAC Lead Associate when requested by the QAC Supervisor.


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