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Jubilant Pharma Limited · 10 hours ago

Technician II, QA Doc Issuance

Spokane, WA

Full-time

Onsite

Entry, Mid Level

$25.11/hr - $33.96/hr

2+ years exp

Jubilant HollisterStier LLC is Spokane’s largest manufacturing company, providing a complete range of services to the pharmaceutical and biopharmaceutical industries. The QA Document Management Associate will be responsible for issuing high-quality documentation to support manufacturing processes, ensuring timely closure of critical documentation workflows, and maintaining communication with various departments to facilitate efficient operations.

Health CareManufacturingPharmaceutical

Responsibilities

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

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

Coordinate with Planning Department to ensure successful components are acquired and criteria is met for timely release of BPRs in SAP Database System

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

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

Quality issuance and quality control of high volume of Controlled Documents, Component Production Records, Pass-Through Logs, Batch Production Records etc. to manufacturing floor

Initiate and revise department SOPs as needed to align with the necessary streamlined workflow critical to department’s success

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

Provide investigation support and RCA (Root Cause Analysis) input for deviations and CAPA events

Position requires occasional call-in off shift in support of manufacturing activities

Qualification

EDMS administrationSAP Database SystemAdobe AcrobatFDA Regulated IndustryMS WordMS ExcelAttention to detailCommunication skills

Required

High School Diploma or Equivalent required

2-3 years related experience required

Possess excellent computer skills required

Have proficiency with MS Word and Excel required

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

Preferred

Associate of Arts or Science desired

FDA Regulated Industry Experience desired

Benefits

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

Company

Jubilant Pharma Limited

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to our customers across geographies.

Founded in 2014

Singapore, Central Region, SGP

1001-5000 employees