Quality Assurance Compliance Specialist

3 days ago

Spokane, Washington, United States Jubilant HollisterStier LLC Full time
Job Title: QA Compliance Associate/Sr. Associate

Jubilant HollisterStier LLC, a leading pharmaceutical and biopharmaceutical company, is seeking a highly skilled QA Compliance Associate/Sr. Associate to join our team.

The successful candidate will provide support to our Deviations, Corrective and Preventive Action (CAPA) program, ensuring product compliance and safety. Key responsibilities include:

Key Responsibilities:
  • Review deviations, investigations, and CAPAs to ensure accuracy, consistency, and compliance with applicable SOPs/Policies, Specifications, and related guidelines/regulations.
  • Facilitate deviation investigation/resolution, assess product impact, and complete/writer final assessment/lot disposition for QA Management and Client review and approval.
  • Enter data into database in support of corporate RCA and CAPA activities.
  • Provide oversight of investigational RCA group activities, including preparation of meeting agenda, providing necessary information to meeting participants, 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 quality systems, processes, and procedures to ensure compliance and product quality and safety.
  • Assist QA and applicable Department Management to ensure and follow up on implementation of corrective actions stemming from deviations, audits, or regulatory inspections.
  • Provide deviation and CAPA metrics as needed in support of management review of system data.
  • Work extensively with appropriate departments to gain an understanding of the production/analytical testing process and other applicable processes to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
Qualifications:
  • Associate's degree in Biology, Chemistry, or related field required. OR 5 years of experience may be used in lieu of an Associate's degree. Bachelor's degree in a science field desired.
  • Minimum 2 years of experience required. Bachelor's degree can be used in lieu of experience.
  • Pharmaceutical and FDA-regulated industry experience desired.

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