Documentation Reviewer

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 Documentation Reviewer will oversee documentation by working with manufacturing personnel on a daily basis to ensure right first time for all documentation prior to QA release submission. The specialist will gather, organize, and review all documentation associated with CMO manufacturing including batch records, daily packets, CSD logs, EE Logs and other miscellaneous documentation. The specialist will be responsible for ensuring all documentation is submitted "right first time" and in a timely manner. The specialist will also ensure corrections are performed in a timely manner by tracking returns and coordinating with manufacturing technicians until completion of corrections. The Specialist will perform monthly SOP audits in the manufacturing areas and data entry.

1. Review CMO batch records
2. Print out Yokogawa reports, SCADA, fill check average sheets, and Lyo batch reports to route with batch records.
3. Review entrance egress logs, LUMACs, port logs, cleaning logs, daily packets, and other manufacturing documentation. Route mail and packets throughout building.
4. Follow up with technicians and shift leadership for documentation corrections
5. Identify areas of improvement in manufacturing documentation to reduce errors
6. Drive batch record turnaround times to reduce time from end of run to routing the record to QA
7. Improve RFT documentation to contribute to site KPI
8. Perform data entry into various trackers.
9. Update SOP manual lists, replace SOP and perform monthly SOP audits in manufacturing areas.

Qualifications:

• High School Diploma or equivalent required
• Minimum 2 years of related experience required
• Pharmaceutical Experience or other Regulated Industry desired
• MS office experience required
• Seated for long periods of time required

Shift: Weekday days, Monday- Friday, 5:00am - 1:30pm

Compensation & Benefits:

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

Hiring Wage: $30.93- $ $41.85% 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