QA Label Control Operations Specialist

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 QA Label Control Operations Specialist leads a team that completes the counting, assembly, printing and distribution of Label Control components for production. Components are organized and maintained in controlled access areas. The Specialist coordinates process improvement suggestions and review of updates to the Label Control process as well as design and review of labeling components for production use. They will become a Subject Matter Expert (SME) in: label serialization, product dating procedures and a variety of material movement functions-working closely with many different departments toward the timely packaging and release of critical batches while responding to shifting production needs. Primary focus will be daily operations and schedule coordination. Secondary focus will be supporting QA Label control Project Specialist. Essential responsibilities include but are not limited to:

1. Coordinate the counting (both manual and machine-assisted) of Label Control components and executing over two dozen SAP material movement transactions. Maintain inventory control, stock and organize Label Control warehouse and confirm correct locations and revisions of material. Maintain inspection readiness in all Label Control areas. Coordinate and track movement of materials to offsite Warehouse.
2. Facilitate the controlled printing, assembly, and distribution of Label Control components according to production schedule and priority requests. Learn to operate and train others in the operation of multiple pieces of equipment i.e. Label Control printers, rewinders, scanners etc. Help to address any mechanical issues with the equipment.
3. Operate label printing software and learn to troubleshoot intermediate system communication issues with SAP, label printing software, GMP Label Servers and the serialization process (rFxcel). Communicate with the appropriate personnel to resolve these issues.
4. Design and review label formats in the label design system. Coordinate label design software updates, label printing software updates, server updates, and new equipment validation and testing.
5. Learn and understand the differences between ABU and CMO label printing, label design, and component order and assembly.
6. Adapt quickly and efficiently to shifting production needs by determining component counting reouirements, ppropriate paperwork, and SAP dating updates by communicating with relevant departments. Maintain awareness of running priority product list and expedited Label Control orders. Provide direction and awareness to technicians regarding the above.
7. Provide RCA (Root Cause Analysis) input for deviations and CAPA events. Assist SVP Packaging and SLM Finishing with investigations.
8. Navigate and print from eDMS.
9. Coordinate with Label Control Project Specialist for department SOP revisions in eDMS as well as in the initiation/design/completion of process improvements.
10. Position requires occasional call-in off shift in support of manufacturing activities.

Qualifications:

• High School Diploma required
• Associate of Arts or Science preferred
• 3-5 years related experience required
• MS Word, Excel proficiency required
• Database experience required
• Familiarity with Labeling software and systems desired
• Basic understanding of serialization desired
• FDA Regulated Industry Experience desired
• Math skills for calculating dates, parts, and percentages are preferred
• Forklift experience desired, must be able to obtain within 3 months
• Manufacturing production and equipment operation experience is desired
• Ability to lift 40 lbs. unassisted required
• Repetitive activity, Pushing, pulling, Prolonged sitting and standing, Twisting, Standinq, walking, stoopinq and reaching required

Shift: Weekday Days, Monday-Wednesday E/O Thursday

Compensation & Benefits:

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

• Hiring Wage: $30.99 - $41.93 hr. 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