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Technical Quality Specialist

Job Summary

The Technical Quality Specialist will be working with the quality unit to assure continuous improvement through batch investigations, annual product reviews, risk assessments and tracking and trending of data.  Reduce potential adulteration, whether intentional or unintentional, and provide support to all departments in service of this goal. 

Duties and Responsibilities

  • Perform Batch Investigations to determine root cause for OOS Batch Results, Customer Complaints or Deviations.
  • Develop and maintain metrics or key performance indicators for determination of risk mitigation effectiveness and to assist with investigations.
  • Provide statistical support of risk assessments
  • Represent quality risk management on cross functional teams
  • Perform annual product reviews (as required by customer)
  • Draft new and review and edit existing SOPs for accuracy and compliance with internal procedure/policy and applicable regulations.
  • Provide statistical support to QC laboratory and other departments as needed.
  • Assist with projects as assigned by Management.
  • Other duties as assigned.

Qualifications, Knowledge, Skills, & Abilities

  • A bachelors degree in Food Science or other related science field
  • Significant familiarity with 21CFR110, 21CFR117 and 21CFR111
  • Experience in a Quality Assurance cGMP environment
  • Experience with manufacturing environments
  • Proficiency with Microsoft Office
  • Knowledge of Power BI helpful
  • Skill in Risk Management practices
  • Strong ability to perform and defend statistical analysis of risk
  • Strong verbal and written communication skills and interpersonal skills.

 

Physical Requirements

Office Role

The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

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