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 Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.
• Responsible for decision making of 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 approve Validation related documentation such as risk assessments, protocols and test scripts and summary reports.
• Review and approve change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.
• Coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
• Interpret complicated data and make sound decisions.
• Telecommuting permitted. M.S. in Computer Science, Information Technology, or a related field.

Requirements:

• 12 months' experience as QA Lead, Sr. Computer Systems Validation Engineer, Validation Lead, or a similar position.
• 12 months' experience in: Defect management, Risk/ Gap Assessment, authoring and owning the validation deliverables for the change management, support Change Control, deviation resolution (CAPA), Master Control - Quality Record Management System, Blue Mountain, GxP, and Data Integrity.
• University coursework must have included: Analyzing & Visualization Data, Information security and risk management.

Job Details & Benefits:

• 40 hrs/wk. 8:00 am - 5:00 pm. $174,720/year.
• Medical, dental, and vision insurance.
• 401(k). PTO/ sick leave in accordance with applicable law and company policy.
• Professional development and training opportunities.