38961_Compliance Specialist I

Compliance Specialist

Jubilant HollisterStier, Spokane's largest manufacturing company, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is a proud member of the Jubilant Pharma family. Our Promise : Caring, Sharing, Growing We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions through growth, cost effectiveness and wise investment of resources.

The Compliance Specialist is responsible for maintaining regulatory compliance and quality standards within the manufacturing environment. This role manages a variety of compliance activities, including but not limited to Environmental Monitoring Investigation Reports (EMIRs), Environmental Deviation Reports (EDRs), TrackWise deviations, investigation tasks, and area documentation. The specialist ensures that investigations, corrective actions, and related tasks are completed accurately, on time, and in alignment with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and established Service Level Agreements (SLAs). In addition to managing documentation and investigations, the Compliance Specialist partners closely with area specialists, training specialists, and cross-functional teams to support compliance initiatives, promote audit readiness, and identify opportunities for process improvement. This position requires strong attention to detail, organizational skills, and a proactive approach to driving compliance across the department, ultimately ensuring product quality, regulatory alignment, and patient safety.

1. Prepare and manage Environmental Monitoring Investigation Reports (EMIRs), Environmental Deviation Reports (EDRs), TrackWise deviations, and investigation tasks in alignment with quality and regulatory requirements.

2. Ensure timely completion of investigations, root cause analyses, and corrective / preventive actions (CAPAs) to meet established Service Level Agreements (SLAs).

3. Maintain area documentation and records to ensure compliance with GMP, SOPs, and applicable regulatory standards.

4. Partner with area specialists, training specialists, and cross-functional teams to support compliance initiatives.

5. Provide manufacturing support when required.

6. Identify and recommend process improvements to strengthen compliance practices and drive efficiency.

7. Support audit readiness by ensuring accurate, complete, and well-maintained documentation and records.

8. Perform additional compliance-related tasks and responsibilities as assigned.

Qualifications :

• High School Diploma or Equivalent required.
• Associate or Bachelor degree desired.
• 2 years manufacturing experience required.
• Leadership experience desired.
• Pharmaceutical manufacturing experience desired.
• Working knowledge in Microsoft Word, Excel and PowerPoint required.
• SAP experience required.
• Trackwise and MasterControl experience required.
• Respirator Clearance Required.

Shift : Weekday Nights, Monday Wednesday E / O Thursday 6pm-6am.

Compensation & Benefits : This is an on-site, full-time position located in Spokane, WA. Hiring Wage : CMO Compliance Specialist I.