Quality Assurance Specialist

Position Summary:

Glenmark is seeking a Quality Assurance Specialist to join its growing team! Based out of Glenmark's brand new manufacturing facility in Monroe, NC, the Quality Assurance Specialist will be responsible for authoring and approving Deviations, CAPAs, Change Controls, and Customer Complaints. This role will ensure robust quality records and timely closure.

Key Responsibilities:

  • Develops Standard Operating Procedures (SOPs) governing Quality Management Systems.
  • Implements process flows that ensure on-time closure of records and projects.
  • Ensures change controls are properly justified, and closed in a timely manner.
  • Investigates both Non-conformances and Deviations.
  • Maintain current knowledge of regulatory and industry standards, trends and advancements.
  • Supports regulatory inspections.
  • Establish Key Performance Indicators (KPI's) for functional area and ensure systems are operating within target.
  • Support facility start-up activities as needed.


  • BachelorÔ s degree in scientific discipline or closely related technical field of study required.
  • Equivalent experience will be considered.


  • Pharmaceutical & FDA/GMP industry experience is required.
  • High level understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
  • Root Cause Analysis.


  • Excellent verbal and written communication skills.
  • Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
  • Strong organizational, analytical, troubleshooting and problem-solving skills.
  • Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.
  • Knowledge of LIMS (Laboratory Information Management System) is a plus.


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