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Synkriom Logo Synkriom · IT - Administration

Qa Lead Technical Operations

United States, Piscataway Employment contract 174720.00 USD / Year · Job Posted July 04, 2026
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Job Description

Provide Quality Assurance (QA) support to the Devens site and reporting manager through quality review and approval of investigations and corrective actions. Make quality decisions regarding non-conformances through a strong understanding of Quality Systems and regulatory requirements. Review and approve Quality, Quality Control, Validation, and Automation-related documentation. Review and approve Standard Operating Procedures (SOPs). Review and approve validation documentation, including risk assessments, protocols, test scripts, and summary reports. Review and approve change proposals and associated deliverables while ensuring compliance with regulatory and internal WWQC guidelines. Coach cross-functional teams on investigations, CAPAs, risk assessments, and validation processes. Interpret complex data and make sound quality-related decisions. Support telecommuting as permitted.

Job Responsibility

  • Provide Quality Assurance (QA) support to the Devens site and reporting manager through quality review and approval of investigations and corrective actions
  • Make quality decisions regarding non-conformances through a strong understanding of Quality Systems and regulatory requirements
  • Review and approve Quality, Quality Control, Validation, and Automation-related documentation
  • Review and approve Standard Operating Procedures (SOPs)
  • Review and approve validation documentation, including risk assessments, protocols, test scripts, and summary reports
  • Review and approve change proposals and associated deliverables while ensuring compliance with regulatory and internal WWQC guidelines
  • Coach cross-functional teams on investigations, CAPAs, risk assessments, and validation processes
  • Interpret complex data and make sound quality-related decisions
  • Support telecommuting as permitted

Requirements

  • Master’s degree in Computer Science, Information Technology, or a related field
  • 12 months of experience as a QA Lead, Senior Computer Systems Validation Engineer, Validation Lead, or a similar position
  • 12 months of experience in defect management, risk/gap assessments, and authoring and owning validation deliverables for change management
  • Experience supporting Change Control and deviation resolution (CAPA)
  • Experience with MasterControl Quality Record Management System
  • Experience working with Blue Mountain, GxP, and Data Integrity requirements
  • University coursework in Analyzing & Visualization Data
  • University coursework in Information Security and Risk Management

What we offer

  • Comprehensive medical, dental, and vision insurance
  • 401(k) retirement plan
  • Paid Time Off (PTO) and sick leave in accordance with applicable law and company policy
  • Professional development and training opportunities
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