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QA Specialist II – Investigations

LSNE Contract Manufacturing

This is a Full-time position in Manchester, WA posted March 9, 2021.

QA Specialist II
– Investigations+ Jobs+ LoginEmail Me Similar JobsEmail Me This JobThe QA Specialist II Investigations is part of a team of QA professionals who work with other departments to ensure the quality of products, compliance with internal procedures and external standards.

The Specialist is responsible for evaluating deviation incidences and determining which warrant escalation to an investigation, quality review and approval of investigation, and then creating and monitoring the associated CAPAs.

In this role, the opportunity exists to provide input to aid in the transform of GxP programs by providing QA expertise and guidance to lead product candidates and pipeline assets.JOB DUTIES+ Contributes to the quality oversight and administration of the deviation/investigation and CAPA programs+ Reviews and approves Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance+ Active member and participant in investigations and CAPAs+ Ensures timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs+ Reviews and provides input to improve quality system procedures, specifications, and test methods+ Reviews and may approve CAPAs to prevent recurrence of deviations+ Reviews and may approve Change Control documentation+ Is responsible for tracking investigations and change control for timely completion.

Provide status reports, including relevant quality metrics and participates in the management review process+ Establishes collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.+ May be called upon to monitor and identify quality process and system improvements.

Contributes to improvement projects and may communicate status to management+ May serve as QA representative to assigned cross functional project teams such as tech transfer, process validation, and process improvement+ Performs review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements.

Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization+ Other duties as assignedPROFESSIONAL SKILLSExperience performing RCA, technical writing, and working with quality related investigations; Ability to make risk based decisions and resolve issues with guidance; Strong interpersonal skills and the ability to communicate well orally and in writing; Proficiency in MS Office including Word, Excel, Access and VisioEXPERIENCEExperience performing RCA, technical writing, and working with quality related investigations; Knowledge of laboratory and production equipment and IQ/OQ/PQ; Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH;Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9EDUCATIONBachelor’s Degree in a relevant scientific discipline preferred with a minimum of 5 years of pharmaceutical or biotech industry experience with 4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production; ASQ certification preferredQUALITIESAbility to work in a dynamic, fast paced work environment; Honesty, integrity, respect and courtesy with all colleagues; Resilient through operational and organizational changeThe full job description is available upon request.

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