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.