Senior Specialist, Compliance

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 Senior Specialist, Compliance will be the key touchpoint between operations and quality compliance. This role will be responsible for owning and driving the closure of minor deviations with emphasis on completion within SLA. Additionally, this role will include assisting operations leadership in completing investigation tasks and action items as assigned by quality for the purpose of closing deviations. The Senior Specialist role will also initiate and drive CAPAs and Change Controls to bring the area into a state of full compliance.

1. Initiate, investigate, and GEMBA deviations that occur in real time
2. Work closely with QA Compliance to drive deviation closure
3. Attend Root Cause Analysis meetings to ensure accurate identification of what led to failures
4. Responsible for the implementation of corrective actions that stem from deviations, audit, or regulatory filings
5. Drive minor deviations to closure within SLA
6. Drive action items and investigation tasks to closure within SLA
7. Assist operations leadership with deviation investigation across all shifts
8. Perform interviews with technicians and provide evidence in MEMO format
9. Review Avigilon footage
10. Initiate and drive to closure CAPAs and Change Controls related to compliance findings
11. Author test plans for re-inspection of product and obtain client approval where necessary
12. Redline and update SOPs as needed to increase compliance across the department
13. Follow up on paperwork corrections
14. Other duties as assigned.

Qualifications:

• High School Diploma or Equivalent required.
• Access to or ability to gain access to TrackWise and Avigilon desired.
• Training coordinator in LMS desired.
• 2 to 5 year(s) related experience required.
• Pharmaceutical and FDA regulated industry Experience Preferred.
• Training and/or Leadership Experience preferred.
• Microsoft Office experience desired.
• Strong analytical skills and proficiency in data analysis tools and techniques required.
• Experience in project management and coordination required.

Shift: Monday- Friday 8:00am- 4:30pm.

Compensation & Benefits:

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

• Hiring Wage: $77,968.80 - $120,000 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