Compliance System Qualification and Governance Specialist

Jubilant HollisterStier LLC, Spokane's Largest Manufacturing Company, and well-established member of the business community, 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.

Job Description: The Compliance System Qualification and Governance Specialist will provide oversight of analytical instrument qualification activities to ensure compliance of laboratory systems throughout the instrument lifecycle. This role combines expertise in data governance, equipment qualification, and compliance with regulatory requirements to support robust laboratory operations and continuous improvement initiatives. This person will also perform instrument maintenance, training, and troubleshooting.

Qualifications:

• Bachelor of Science in Chemistry, Biology or related hard science required
• 5+ years pharmaceutical QC, QA, or engineering roles with focus on compliance and validation required.
• Experience with laboratory instrumentation preferred
• Experience with computer related systems, databases, and/or servers preferred
• Familiarity with SAP, laboratory informatics systems, documentation practices and regulatory audits preferred
• Lead and guide instrument qualification efforts for QC laboratory instruments, including preparation and review of acceptance reports and qualification documentation.
• Assist with instrument maintenance and troubleshooting. Diagnose and troubleshoot equipment issues, ensuring timely resolution and compliance.
• Determine appropriate user permissions for laboratory equipment and associated workstations to maintain compliance with regulatory requirements.
• Collaborate with QC Analytical/Microbiology on instrument and/or software upgrades to ensure business continuity for QC systems, facilitating CAPEX projects in support. Participate in cross-functional project teams for system installations and upgrades, as applicable.
• Lead and coordinate implementation of improvements to laboratory compliance and equipment maintenance and qualification processes. Additional tasks as assigned by leadership.
• Stay informed of changes to compendial and regulatory requirements for laboratory equipment and ensure compliance with data integrity policies and programs in alignment with GMP and regulatory standards.
• Develop and maintain SOPs related to data integrity, equipment qualification, administration, and maintenance. Assist with data integrity related risk assessments and system documentation.
• Perform compliance audits and periodic reviews of laboratory equipment and associated computer systems, ensuring proper backup and security of electronic data and appropriate system permissions.
• Demonstrate leadership and subject matter expertise within and outside the department as needed. Provide support during internal and external audits for DI/AIQ compliance.
• Maintain training compliance and assist in training other analysts.
• Adhere to all aspects of plant safety programs and in keeping with GMP's or other regulations.
• Microsoft Word required.
• Microsoft Excel required.
• Manual Dexterity required.
• Knowledge, practical application and understanding of the sciences are necessary to perform the functions of this position required.
• Must demonstrate initiative and a willingness to learn required.
• Knowledge of chemistry, statistics, computer-assisted data processing, and good manufacturing practices desirable required.
• Must have an ability to utilize scientific literature, and to make effective written and oral reports that are clear, accurate, and logical required.
• Must be self-motivated with good communication and human relation skills, and must be able to effectively schedule, prioritize, and organize their time.
• Must demonstrate the ability to work in a team setting supporting project teams as a Quality Unit representative.
• Accountability - freedom to act independently - is subject to practices/well defined policy, management reviews results after the fact.
• Accountability - influence on end results - provides analysis, diagnosis or production tasks which noticeably impact end results.

Shift: Monday-Friday 8:00AM-5:00PM

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

Hiring Wage: $89,300.00 - $119,000 annually depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role

• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off plan
• Employee Assistance Program

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

https://jubilantcareer.jubl.com/

*Please click on the Spokane, Wa. Link*

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If you require assistance applying for a position, please contact our HR Department at:

JHS-TalentAcquisition@jubl.com