Quality - Quality -Data Analyst - Summit - Omni Inclusive

Omni Inclusive Summit

5 days ago

Description

Job Summary

The DM analyst is responsible for evaluating Deviations to identify patterns and trends, monitor trend investigations E2E including CAPAS and EC to eliminate trends, perform analysis of deviation data and summarize information for Annual Product Quality Review and other required reports.

Required Competencies:

Knowledge of cGMP manufacturing, Quality, and compliance
Experience with Deviations, Root Cause Analysis, and CAPAs
Knowledge of data trending and tracking, including use of statistical analysis software
Proficient in Excel data mining and report creation
Ability to use electronic Quality systems such as Infinity

Duties and Responsibilities:

Responsible for trending of deviations at S12
Facilitates Trending Governance meetings
Issues minutes and notifies senior leadership of any risks or delays
Reviews all deviations and notifies management of any trends

Education and Experience:

Associate degree or higher required
Minimum of three years of experience in the pharmaceutical or related industry

Working Conditions:

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time.

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