Quality Assurance Analyst

4 weeks ago


Akron, Ohio, United States Omni Inclusive Full time

Job Title: Quality Assurance Analyst

Job Summary:

We are seeking a highly skilled Quality Assurance Analyst to join our team at Omni Inclusive. The successful candidate will be responsible for evaluating deviations, identifying patterns and trends, and monitoring trend investigations to eliminate trends.

Key Responsibilities:

  • Evaluate deviations and identify patterns and trends
  • Monitor trend investigations and eliminate trends
  • Perform analysis of deviation data and summarize information for Annual Product Quality Review and other required reports
  • Notify management of identified trends

Requirements:

  • Associate degree or higher required, minimum of three years of experience in the pharmaceutical or related industry
  • Knowledge and experience with 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

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.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.

The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.

Employees holding this position will be required to perform any other job-related duties as requested by management.



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