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Quality Assurance Validation Specialist

Your Role:  

The Quality Assurance Validation Specialist serves as the contact for quality projects and continuous improvement efforts regarding validation and quality risk management. The Quality Assurance Validation Specialist supports ongoing validation efforts and quality systems responsibilities in support of the manufacture, testing, and release of formulated drug substance. This role contributes to the development of concepts and techniques specific to validation and risk management. This role is paramount to ensure the efficacy and quality of our manufacturing processes which will ultimately yield safe drug products for patients.

 

Responsibilities:

  • Applies and enhances existing programs for the validation of new production and laboratory equipment and utilities, including major capital projects.
  • Drafts, reviews, executes and approves protocols and reports related to equipment and utilities validation. This includes deviation reporting during execution.
  • Ensures that the site Validation Master Plan remains current and aligned with corporate policies as it pertains to equipment and utility system validation.
  • Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support corrective action, preventive action (CAPA), Change Control, Deviation, Risk Management, and Investigation processes.
  • Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and Regulatory Affairs.

 

Basic Qualifications

  • Bachelor's Degree in technical discipline (e.g. biotechnology, biology, engineering, chemistry)
  • Associate's Degree in technical discipline (e.g. biotechnology, biology, engineering, chemistry)
  • 3+ years experience in GMP environment

Preferred Qualifications

  • Knowledge of calibration methodology, equipment, and instruments.
  • Knowledge of software including: CAD, Minitab, and Microsoft Office
  • Experience with use of quality systems and processes in a regulated environment (GLP, cGMP, ISO)
Job Requisition ID:  187436
Location:  Madison
Career Level:  C - Professional (1-3 years)
Working time model:  full-time


Job Segment: Biotech, Developer, CAPA, QA, Science, Technology, Quality, Management

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