Sr. Specialist, Test Kit (I&P)

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, Test Kit - Inspection and Packaging Department is responsible for assembling, maintaining, and calibrating visual inspection test sets, ensuring their readiness for use for the Visual Inspection Qualification Program. This role involves creating and maintaining a defect library, documenting the design and lifecycle management of test sets, and performing visual inspections of pharmaceutical products per regulatory guidelines. The specialist conducts Knapp studies, troubleshoots test set issues, collaborates with cross-functional teams, and adheres to safety protocols and Good Manufacturing Practices (GMP). Staying current with industry regulations, participating in continuous improvement initiatives, and developing Standard Operating Procedures (SOPs) are also key responsibilities. This position requires expertise in visual inspection standards, quality control principles, and equipment maintenance and calibration.

1. Assemble, maintain, and calibrate visual inspection test sets, ensuring their readiness for use.
2. Assemble, maintain, and calibrate visual inspection challenge sets for automatic visual inspection.
3. Create and maintain a defect library for training and reference purposes.
4. Document the design and lifecycle management of test sets, keeping accurate records.
5. Perform visual inspections of pharmaceutical products in accordance with regulatory guidelines.
6. Conduct Knapp studies to identify baseline inspection thresholds.
7. Troubleshoot and address issues related to test sets and equipment.
8. Collaborate with cross-functional teams, including quality assurance, production, and engineering.
9. Adhere to safety protocols and Good Manufacturing Practices (GMP).
10. Stay current with industry regulations and standards to ensure compliance.
11. Participate in continuous improvement initiatives to enhance inspection processes.
12. Develop and update Standard Operating Procedures (SOPs) related to test sets.
13. Other duties as assigned.

Qualifications:

• High School Diploma or Equivalent required.
• PDA Courses related to Visual Inspection desired.
• 2 to 5 year(s) related experience required.
• Visual Inspection and Pharmaceutical Experience preferred.
• FDA Regulated Industry Experience preferred.
• Training and/or Leadership Experience preferred.
• Microsoft Office experience desired.
• Knowledge of visual inspection standards and techniques, including USP <790> and USP <1790> required.
• 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