Lead QA Release Coordinator

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 Lead QA Release Coordinator is responsible for day-to-day prioritization and ensuring documentation is assigned appropriately amongst the QA Release team. The incumbent also is responsible for determination of the acceptability of manufactured products and components for final release by reviewing production, supporting documentation and SAP test results to ensure compliance with product/component specifications.

1. Maintain department metric spreadsheets and provide data as requested.
2. Receipt/logging/assignment of items routed for review daily.
3. Review and release of RM packets, JHS Product manufacturing records, Non-Compounded contract batch records, and QA documents within established lead times to ensure compliance with established product/component specifications.
4. Revise and maintain SOP's.
5. Create department-related change controls and CAPAs and manage timelines appropriately within the Trackwise program.
6. Perform SAP Transactions: including but not limited to updating Inspection Plans and verifying Material Masters/recipes..
7. Communicate with stakeholders/clients/site leaderhip and other departments on documentation related to batch record review and release.
8. Prepare batch records to be copied/scanned.
9. Serve as a QA Representative on project teams as needed to support Manufacturing.
10. Utilize Avigilon Camera System to assist in batch record review as required.
11. Participate on project teams.
12. Mentor/train new personnel coming into the deparment.
13. Perform other QA departmental functions as assigned by supervisor or manager.
14. Identify continuous improvement opportunities and propose solutions.

Qualifications:

• Bachelor of Science or 4 years of direct experience in lieu of degree required
• Minimum of 3 years Pharmaceutical Experience required
• FDA Regulated Industry Experience required
• Minimum 2 years of exposure to aseptic processing, cGMP's required
• Lead Experience desired
• Microsoft Word and Microsoft Excel experience required
• SAP experience required
• Trackwise experience required
• Prolonged sitting and computer use

Shift: Weekday days, Monday-Friday

Compensation & Benefits:

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

• Hiring Wage: $30.99 - $41.93hr.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