Manufacturing Quality Specialist II

10/16/20

Charlotte, NC 28115

1071

FullTimeRegular

The Manufacturing Quality Specialist II is responsible for authoring and reviewing quality incident investigations and performing Root Cause Analysis (RCA). This individual will support release metrics, support process improvement efforts on the manufacturing floor, complete Corrective and Preventive Actions, and initiate/complete change controls. Must be alert to opportunities to improve performance through better quality, safety, and increased efficiency to achieve individual and departmental goals.

Essential Duties and Responsibilities

  • Writes and reviews quality incident investigations within due dates. Interview personnel, review documentation, procedures, batch records, and training documentation. Identify root cause and works with Manufacturing to identify appropriate corrective actions.
  • Processes the documentation for corrective and preventive actions
  • Develops and authors change controls to support quality improvements
  • Leads groups in Root Cause Analysis for necessary investigations
  • Supports cGMP-focused continuous improvement activities in the manufacturing areas
  • Maintains KPIs for investigations, CAPA, and Change controls
  • Supports customer and regulatory cGMP inspections
  • Performs other duties as assigned

Supervisory Responsibility

This position has no direct reports.

Knowledge and Skill Requirements:

  • Sense of Urgency
  • Detail Oriented
  • Ability to communicate and address problems at all levels of the organization
  • Demonstrated facilitation, problem solving, and analytical skills
  • Must be confident, resourceful, self-reliant and self-motivated
  • Understands cGMP regulation and quality management systems for pharmaceutical operations
  • Ability to speak with contract customers about investigation reports
  • Strong communication and presentation skills, both oral and written with a demonstrated ability to present key quality/department/business indicators to both first-line staff and senior management
  • Must have a practical knowledge of manufacturing processes, machinery and equipment in area of responsibility.

Education and Experience:

Bachelor’s degree in Engineering or Science and 5+ years’ experience as a technical writer in a cGMP Manufacturing or Quality department required; or equivalent combination of education and experience.

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