Quality Assurance Specialist

Position Overview


The Quality Assurance Specialist is responsible for supporting quality system processes and maintaining high standards of compliance, documentation accuracy, and process control.

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Duties & Responsibilities
Key responsibilities include, but are not limited to:

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  Generate, review, correct, and archive documents supporting Good Manufacturing Practice (GMP) production activities.
  
  
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  Conduct internal and external audits as assigned.
  
  
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  Review and release raw materials, intermediate products, and finished goods; assist with incoming material and container inspections.
  
  
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  Review and approve OOS (Out of Specification), deviations, nonconformances, and investigations.
  
  
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  Coordinate CAPA, OOS, deviation, nonconformance, and investigation activities.
  
  
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  Ensure compliance with current SOPs and quality system requirements.
  
  
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  Assist with investigations and support resolution of product quality issues to enhance operational efficiency.
  
  
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  Create, revise, and approve standard operating procedures and work instructions.
  
  
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  Review and approve SOPs, protocols, and reports as required.
  
  
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  Coordinate and/or deliver GMP and SOP training.
  
  
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  Generate, track, and publish quality system metrics to support continuous improvement initiatives.
  
  
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  Scan and archive GMP records and documentation.
  
  
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  Support Quality Control Laboratory functions such as calibration and product release activities.
  
  
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  Provide assistance to Environmental, Health, and Safety programs as needed.
  
  
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  Perform other duties as assigned by the Quality Assurance Manager.
  
  

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General Requirements

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  Bachelor’s degree in a scientific discipline or equivalent experience.
  
  
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  Minimum of 2 years' experience in a cGMP/FDA-regulated environment (preferred) and working with ISO 9001 within Quality Assurance or Compliance functions.
  
  
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  Proficiency in Microsoft Office, especially Excel.
  
  

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Skills, Qualifications & Experience

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  Strong knowledge of ISO 9001:2015, ISO 14001:2015, cGMP, CFR 210/211, FDA requirements
  
  
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  Experience in a manufacturing environment (chemical manufacturing or processing preferred).
  
  
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  Familiarity with Statistical Process Control (SPC) and relevant software tools.
  
  
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  Ability to evaluate and quantify cost of quality using data-driven KPIs.
  
  
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  Strong project management, time management, and conflict-resolution skills