Senior Technical Operations Quality Assurance Manager

3 days ago


Devens, Massachusetts, United States Axelon Services Corporation Full time
Job Overview

Axelon Services Corporation is seeking an experienced Senior Technical Operations Quality Assurance Manager to join our team.

Estimated Salary Range

$85,000 - $110,000 per year based on location and experience.

Job DescriptionKey Responsibilities
  • Provide quality assurance support to Devens site and reporting manager through quality review and approval of investigations and corrective actions.
  • Making decisions on non-conformance through a deep understanding of quality systems regulatory expectations.
  • Review and approve quality, quality control, validation, and automation-related documents.
  • Review and approve standard operating procedures (SOPs).
  • Review and approval of validation-related documentation such as risk assessments, protocols, test scripts, and summary reports.
  • Review and approval of change proposals and associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.
  • Cochrane across different departments within the subject matter of investigations, CAPAs, general risk assessments, and validation.
  • Self-manage and prioritize work across multiple competing deliverables in a remote working environment.
  • Ability to interpret complicated data and make sound decisions independently.
Requirements
  • Bachelor's degree in a related field.
  • At least 5 years of experience in quality assurance or a related field.
  • Proven track record of successfully managing quality assurance programs.
  • Strong knowledge of quality systems regulatory expectations.
  • Excellent communication and interpersonal skills.


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