QA Lead Technical Operations ( Piscataway, NJ, or other unanticipated locations throughout the U.S.).

Job Location: Piscataway (NJ) or other unanticipated locations throughout the U.S.

Responsibilities:

• 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.

Job Details & Benefits:

• Full-time position (40 hours per week).
• Work schedule: 8:00 AM - 5:00 PM.
• Annual salary: $174,720.
• 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.