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Jubilant Pharma Limited · 3 days ago

Lead QA Release Coordinator

Spokane, WA

Full-time

Onsite

Mid, Senior Level

$30.99/hr - $41.93/hr

3+ years exp

Jubilant HollisterStier LLC is a leading contract manufacturer in the pharmaceutical and biopharmaceutical industries, known for its commitment to quality and innovation. The Lead QA Release Coordinator is responsible for prioritizing documentation and ensuring the acceptability of manufactured products for final release, while also maintaining compliance with product specifications and managing departmental metrics.

Health CareManufacturingPharmaceutical

Responsibilities

Maintain department metric spreadsheets and provide data as requested

Receipt/logging/assignment of items routed for review daily

Review and release of RM packets, JHS Product manufacturing records, Non-Compounded contract batch records, and QA documents within established lead times to ensure compliance with established product/component specifications

Revise and maintain SOP’s

Create department-related change controls and CAPAs and manage timelines appropriately within the Trackwise program

Perform SAP Transactions: including but not limited to updating Inspection Plans and verifying Material Masters/recipes

Communicate with stakeholders/clients/site leadership and other departments on documentation related to batch record review and release

Prepare batch records to be copied/scanned

Serve as a QA Representative on project teams as needed to support Manufacturing

Utilize Avigilon Camera System to assist in batch record review as required

Participate on project teams

Mentor/train new personnel coming into the department

Perform other QA departmental functions as assigned by supervisor or manager

Identify continuous improvement opportunities and propose solutions

Qualification

Pharmaceutical ExperienceFDA Regulated IndustryAseptic ProcessingSAPTrackwiseMicrosoft WordMicrosoft ExcelLead ExperienceCGMPContinuous ImprovementMentoring

Required

Bachelor of Science or 4 years of direct experience in lieu of degree required

Minimum of 3 years Pharmaceutical Experience required

FDA Regulated Industry Experience required

Minimum 2 years of exposure to aseptic processing, cGMP's required

Microsoft Word and Microsoft Excel experience required

SAP experience required

Trackwise experience required

Prolonged sitting and computer use

Preferred

Lead 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