Senior Associate, Quality Audit

Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. 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 Senior Associate, Quality Audits primary responsibility will be acting as the main contact for the JHS client and regulatory audit program. This will involve scheduling and hosting audits, assigning observations to relevant JHS teams, and ensuring all audit response are submitted on time. Additionally, as time permits, the incumbent will assist the commercial team with annual product reviews, quality agreements and other QA commercial responsibilities.

1. Responsible for staying current on all regulations regarding audit compliance.
2. Ensure company policies and expectations are well understood and systems are ready for audit and inspection.
3. Develop audit metrics to be used for management reviews.
4. Develop tour and SME staff, ensuring consistency of audits.
5. Schedule, coordinate, host and manage client audits.
6. Manage the process for completion of observation responses for client audits. Evaluate responses for content, accuracy and appropriateness of proposed corrective actions.
7. Host and manage Regulatory audits.
8. Review quality agreements. Ensure agreements are reviewed on an annual basis.
9. Assist in the completion of Annual Product Reviews.
10. Review and approve material Specifications

Qualifications:

• Bachelors in Hard Science or Engineering Required.
• ISO 13485 Lead Auditor and ASQ Certified Quality Auditor desired.
• 5 years pharmaceutical experience required.
• Quality Unit experience desired.
• Electronic documentation management system, TrackWise and/or LMS experience required.
• FDA regulated Industry Experience desired.
• 7 years of experience can be used in lieu of degree.
• 10 or more years' experience desired.
• Supervisory and Laboratory experience desired.
• Functional knowledge that this position requires knowledge of the Code of Federal Regulations, EU guidance, ISO and other industry regulations. It also requires knowledge and interpretation of GMPs and quality systems. The applicant should be able to inspect and identify deficiencies in documents, products and processes.
• Experience in MS Word, Excel, PowerPoint, Access and SAP required.

Shift: Weekday, Days

Compensation & Benefits:

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

Hiring Wage: ($77,968.80- $101,200) 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