Technician II, QA Doc Issuance

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 Document Management Associate is part of a team that issues high quality/high quantity documentation to the CMO and ABU manufacturing floors, ensuring critical timeframe parameters are met for the manufacture of products. Various documents are issued for most aspects of the manufacturing process. These include Controlled Documents, Component Production Records, Pass-Through Logs, and Batch Production Records. The Associate must possess networking capabilities as the moving parts for success include frequent interaction with all manufacturing departments' Leadership as well as the Planning Departments. The Associate is also responsible for numerous eDMS administrative functions to support the facilitation of multiple procedure workflows site-wide. Essential responsibilities include but are not limited to:

1. Intermediate, competent in all job functions and can work independently with minimal guidance.
2. Perform DocAdmin functions in EDMS for multiple procedure workflows, including archival and restore functions, tracked changes and redline acceptance, task reassignment, troubleshooting publishing issues, workflow management, infocard management (editing effective dates upon approved request and deletion) in addition to select report functions. These duties are crucial in support of the timely closure of CAPAs, Change Controls, Investigation tasks etc.
3. Administer the Document Locker system, including setup, system updates, and user management. This system is used to electronically track the issuance of documents to manufacturing and supporting areas and also to secure paperwork during routing from manufacturing to QA groups. Execute system reports on request.
4. Coordinate with Planning Department to ensure successful components are acquired and criteria is met for timely release of BPRs in SAP Database System.
5. Adapt quickly to shifting production needs by determining the relevancy of paperwork that will be required for department specific timeframe requirements. Anticipate patterns in schedule movement to plan ahead and reduce the potential for backlog in distributing paperwork to manufacturing floor.
6. Maintain clear and effective communication with Manufacturing Departments regarding status of SOP revisions and potential impact upcoming revisions may have on near future or current in-process production runs.
7. Quality issuance and quality control of high volume of Controlled Documents, Component Production Records, Pass-Through Logs, Batch Production Records etc. to manufacturing floor.
8. Initiate and revise department SOPs as needed to align with the necessary streamlined workflow critical to department's success.
9. Serve as collaborators for Doc Writers on ALL SOPs that Issuance Department will utilize when building paperwork packets/BPRs for production floor. Attention to detail is critical, as "Right first Time" is imperative to meet timely goals for distribution due to high volume of Issuance department output.
10. Provide investigation support and RCA (Root Cause Analysis) input for deviations and CAPA events.
11. Position requires occasional call-in off shift in support of manufacturing activities.

Qualifications:

• • High School Diploma or Equivalent required
  • Associate of Arts or Science desired
  • 2-3 years related experience required
  • Possess excellent computer skills required
  • Have proficiency with MS Word and Excel required
  • FDA Regulated Industry Experience desired
  • Adobe Acrobat knowledge required.
  • Proficiency in spelling required
  • Prolonged sitting required
  • The incumbent will spend approximately 90% of the time in this position working at a computer.

Shift: Weekday days, Monday-Friday

Compensation & Benefits:

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

• Hiring Wage: $25.11- $33.96 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
• 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