On-Site GMP Compliance Specialist I — CAPA & EMR

Jubilant Pharma, LLC

Spokane, Northern (WA, KY)

Hybrid

USD 43,000 - 62,000

Full time

39 hours ago
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Benefits offered by this job

Medical, Dental, Vision
Life Insurance
AD&D Insurance
Disability Insurance
Employee Assistance Program

Job summary

Jubilant HollisterStier LLC is seeking a Compliance Specialist I to uphold regulatory compliance and GMP standards in a manufacturing environment. The role oversees EMRs, EDRs, TrackWise deviations, and related investigations, ensuring timely CAPAs and alignment with SOPs and SLAs.

Collaborating with area and training specialists, you’ll support audit readiness and continuous improvement. This on-site Spokane position emphasizes attention to detail, coordination, and cross-functional teamwork to

Qualifications

  • High School Diploma or Equivalent.
  • 2 Years’ Manufacturing Experience required.
  • SAP, Trackwise, Master Control, MS Word, Excel and PowerPoint required.

Responsibilities

  • Prepare and manage Environmental Monitoring Investigation Reports (EMRs), Environmental Deviation Reports (EDRs), Track Wise deviations, and investigation tasks in alignment with quality and regulatory requirements.
  • Ensure timely completion of investigations, root cause analysis, and corrective/preventative actions (CAPAs) to meet established Service Level Agreements (SLAs).
  • Maintain area documentation and records to ensure compliance with GMP, SOP, and applicable regulatory standards.
  • Partner with area specialists, training specialists, and cross functional teams to support compliance initiatives.
  • Provide manufacturing support when required.
  • Identify and recommend process improvements to strengthen compliance practices and drive efficiency.
  • Support audit readiness by ensuring accurate, complete, and well-maintained documentation and records.
  • Perform additional compliance-related tasks and responsibilities as assigned.

Education

High School Diploma or Equivalent
Associate or Bachelors Degree

Tools

SAP
TrackWise
Master Control
MS Word
Excel
PowerPoint

Job description

Jubilant HollisterStier LLC is seeking a Compliance Specialist I to uphold regulatory compliance and GMP standards in a manufacturing environment. The role oversees EMRs, EDRs, TrackWise deviations, and related investigations, ensuring timely CAPAs and alignment with SOPs and SLAs.

Collaborating with area and training specialists, you’ll support audit readiness and continuous improvement. This on-site Spokane position emphasizes attention to detail, coordination, and cross-functional teamwork to

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