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 Lead QA Release Coordinator assists Supervisor / Manager with day-to-day responsibilities. Prioritizes and ensures 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.

Essential responsibilities include:

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. Review existing and new SOP's. Submit and make changes to those SOP documents.
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, closing MICs, set up/close SAP notifications, blocking, restricting batches, notification tasks, and verifying Material Masters/recipes.
7. Communicate with stakeholders/clients/site leadership 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. Mentor/train new personnel coming into the department.
11. Perform other QA departmental functions as assigned by supervisor or manager.
12. Identify continuous improvement opportunities and propose solutions.

Qualifications:

• Bachelor of Science or 4 years of direct experience in lieu of degree desired
• 2-3 years related experience desired
• Proficient with Microsoft Word & Microsoft Excel, SAP, Trackwise
• Familiar with Process Improvement
• Communication Skills, both written and verbal
• Ability to make critical observations
• Ability to manage conflict
• Able to evaluate requirements for the quality unit on proposed SOP's

Shift: Days

Compensation:

The annual salary range for this position is $67,275 - $85,514 depending on experience.

Benefits:

• 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
  

Optional Benefits:

• Voluntary Life and AD&D for employee & family
• Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
• Pet Insurance
• ID Theft Protection
• Perk Spot Discount Program

Jubilant HollisterStier is a great place to grow!
If you're up for a rewarding challenge, we invite you to take the first step and apply today!

https://www.jublhs.com/careers/career-opportunities
*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: