QA Release & Issuance Manager

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 QAManager, supports Quality Assurance activities on weekday nights (B shift).

1. Provideon-site QA oversightfor drug product manufacturing, packaging, and labeling operations during weekday nights (B shift) operations. .
2. Performreal-time batch record reviewand approval to support timely product release.
3. Lead or supportinvestigationsinto deviations, non-conformances, and quality events occurring during weekday night operations.
4. Ensure compliance withcGMP, internal procedures, and regulatory requirements.
5. Serve as theQA decision-makerfor B shift operations, escalating issues as appropriate.
6. Collaborate with cross-functional teams including Manufacturing, Quality Control, and Engineering to resolve quality issues.
7. Supportchange control,CAPA, andrisk assessmentsas needed.
8. Participate ininternal and external auditsand inspections, providing documentation and responses as required.
9. Maintain and promote aculture of quality and continuous improvementacross weekday night operations.
10. Providetraining and mentorshipto QA associates and other staff working weekday nights.
11. Ensure the issuance of batch production records and printed packaging components as required by manufacturing processes.
12. When required, establish objectives and conduct performance reviews with direct report personnel.
13. Submit justifications for capital budget items as needed and ensure the approved items are ordered, received and implemented in a timely manner.

Qualifications:

• Bachelor of Arts or Science required. 10 years of experience in lieu of a degree required
• Minimum 5-10 years' experience required
• Supervisory experience required
• FDA regulated industry and Pharmaceutical experience desired
• This position requires knowledge and interpretation of GMP's and quality systems
• Ability to identify deficiencies and support identified solutions required

Shift: Weekday Nights, Monday-Wednesday E/O Thursday 6pm-6am

Compensation & Benefits:

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

• Hiring Wage: $102,100.00 - $163,300 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.
• Shift Differential pay is available for this position, and is determined by hours worked on selected shift.

• 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