Compliance Specialist I

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 CMO

Join a Leader in Pharmaceutical Manufacturing - And Build What's Next

As Spokane's Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

For the Builders, Innovators, and Doers - This Is Your Place

If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you'll feel at home here. At Jubilant HollisterStier, your ideas matter - and your impact is felt globally.

Why builders choose us:

• Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your wellbeing shouldn't have a waiting period.
• A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution.
• A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.

If you want to build something meaningful with a team that values your drive, skills, and ideas - you belong here.

Job Description

The Compliance Specialist I is responsible for regulatory compliance and quality standards within the manufacturing environment. The role manages a variety of compliance activities, including but not limited to Environmental Monitoring Investigation Reports (EMRs), Environmental Deviation Reports (EDRs), Track Wise 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.

• 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.

Qualifications

• High School Diploma and Equivalent.
• 2 Years' Manufacturing Experience required.
• SAP, Trackwise, Master Control, MSWord, Excel and PowerPoint required.
• Associate or Bachelors 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 of time.
• Work in a cleanroom.

Location

Spokane, WA - On Site, Full Time

Shift

Weekend Days - Friday-Sunday + E/O Thursday - 6am-6pm

Hiring Wage

$38.00 / hourly + 12.5% shift differential, with opportunities for growth, promotion, and annual raises.

Compensation & Benefits That Start on Day One - Because Your Well Being Matters

At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

Starting on your first day, you receive:

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

EEO Statement

Jubilant HollisterStier is anEEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Our Promise: Caring, Sharing, Growing

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.