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Overview

Company

Original Job Post

myGwork - LGBTQ+ Business Community · 3 days ago

Quality Specialist III

Los Angeles, CA

Full-time

Onsite

Mid Level

$83K/yr - $125K/yr

3+ years exp

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Responsibilities

Review and analyze lot documentation to resolve anomalies related to reported product failures.

Perform basic product review and failure analysis.

Prepare risk management plan and facilitate risk analysis per Risk Management Policy.

Coordinate and perform stability testing, analyze stability test data, and summarize stability data for submission into the final stability report.

Document and facilitate product development and change risk reviews.

Assist with Post Market Surveillance department functions as needed.

Perform computer operations for data entry and provide tracing/trending reports.

Abide by corporate policies, procedures, and work instructions.

Assist during audits and perform other duties as assigned.

Qualification

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ISO 13485GMP regulationsComplaint handlingTrending toolsReporting techniquesQS trackingData entryProblem-solvingHard-workingTeamworkCommunicationOrganizationMotivationDiagnosticsProcedural Writing

Required

Bachelor's degree in Biological Sciences or a related field.

3 years of experience in a Quality regulated environment.

Able to create presentations, work with spreadsheets, prepare reports and write procedures using MS Word, Excel and PowerPoint software applications.

Detailed knowledge of ISO 13485 and GMP regulations which govern a medical device and diagnostics manufacturing. Knowledge of complaint handling requirements.

Trending tools and reporting techniques.

Lead meetings and obtain consensus among cross functional teams.

Provide accurate QS tracking and trending reports.

Exercise independent discretion and judgment in execution of duties.

Plan and organize oneself in a consistent manner.

Be a self-starter with the ability to positively motivate others in a collaborative fashion.

Establish and maintain effective collaborations staff members.

Effectively communicate both orally and in writing to management, customers and regulatory personnel.

Maintain confidentiality of laboratory information; perform computer operations for data entry.