Pharma Compliance Specialist I — GMP & Audits

Jubilant HollisterStier LLC; Spokane (WA); On-site; USD 52,000 - 63,000; Full time

Job summary

Jubilant HollisterStier LLC in Spokane, WA is seeking a Compliance Specialist I to manage regulatory compliance and quality in manufacturing. You will handle EMRs, EDRs, TrackWise deviations, and investigations, ensuring CAPAs align with GMP, SOPs, and SLAs.

Collaboration with area and training teams is essential to promote audit readiness and continuous improvement. The role emphasizes attention to detail, organizational skills, and proactive compliance leadership to safeguard product quality

Qualifications

• High School Diploma or equivalent.
• 2 years of manufacturing experience required.
• SAP, TrackWise, MasterControl, MS Word, Excel and PowerPoint required.
• Associate or Bachelor's Degree preferred.
• Leadership experience.
• Pharmaceutical manufacturing experience.
• Respirator clearance required.
• Exposure to latex.
• Exposure to moderate noise levels.
• Possible contact with cleaning chemicals.
• Ability to sit or stand for extended periods.
• Work in a cleanroom.

Responsibilities

• Prepare and manage EMRs, EDRs, Track Wise deviations, and investigation tasks per quality and regulatory requirements.
• Ensure timely completion of investigations, root cause analysis, and CAPAs to meet SLAs.
• Maintain area documentation to ensure GMP, SOP, and regulatory standards.
• Partner with area and training specialists and cross-functional teams on compliance initiatives.
• Provide manufacturing support when required.
• Identify and recommend process improvements to strengthen compliance.
• Support audit readiness with accurate documentation and records.
• Perform additional compliance-related tasks as assigned.

Job description

Jubilant HollisterStier LLC in Spokane, WA is seeking a Compliance Specialist I to manage regulatory compliance and quality in manufacturing. You will handle EMRs, EDRs, TrackWise deviations, and investigations, ensuring CAPAs align with GMP, SOPs, and SLAs.

Collaboration with area and training teams is essential to promote audit readiness and continuous improvement. The role emphasizes attention to detail, organizational skills, and proactive compliance leadership to safeguard product quality