Specialist, Facilities Operations QA (Contract)
About The Position
This contract role provides quality assurance oversight and support for facilities and engineering operations across Vertex’s internal CGT manufacturing sites. The position ensures tactical execution of program requirements complies with Vertex standards and procedures, with oversight of Facility and Equipment Preventive Maintenance and Calibration, Critical Alarm Management, and Pest Control programs. The role also reviews work orders, facility-related CAPAs, and deviations. The position supports preventive and corrective maintenance, instrument calibration, system change management, calibration investigations, and planned shutdowns. It provides guidance on containment and controls to protect cleanroom spaces, and technical support for return-to-service cleaning, testing, and GMP facility release. For facility control programs, the role oversees qualified critical system monitoring and alarm systems, including the Environmental Monitoring System (EMS), and partners with cross-functional teams on pest response, documentation, trend reviews, and corrective actions. General quality support includes generating and communicating KPI metrics, assessing program effectiveness, identifying improvement opportunities and risks, conducting gap analysis, and supporting corrective actions and risk communication. The role collaborates across departments and reviews and approves assigned departmental and cross-functional processes biennially. Work is Monday through Friday, onsite at the Jeffrey Leiden Center. The role is offered through a third-party agency partner and is eligible for overtime pay in accordance with applicable requirements.
Requirements
- Demonstrated ability to communicate effectively and influence decision-making outcomes.
- Experience leading quality review of event investigations, root cause analysis (RCA), and CAPA.
- Experience with equipment, facilities, and utility system qualification activities in a cGMP setting, including quality management of change controls.
- Master’s degree with 3–5 years of relevant work experience; or bachelor’s degree in an engineering, scientific, or allied health field with a minimum of 8 years of relevant work experience; or a relevant comparable background.
- Ability to thrive in a high-throughput environment.
- Proficiency using project management processes and tools to lead meetings, assist with project planning, and facilitate task completion.
- Collaboration, teamwork, and conflict management skills.
- Ability to mentor others, transfer technical knowledge, and teach skills to junior staff.
- Ability to influence others within a technical area of expertise.
- Ability to communicate effectively across organizational levels.
- Critical thinking and problem-solving skills, including evaluating quality matters and making risk-based decisions.
- Flexibility, adaptability, and attention to detail.
- Demonstrated ability to work independently and provide QA support for large, multifaceted projects.
Responsibilities
- Provide quality oversight and support for Facilities and Equipment Preventive Maintenance and Calibration, Critical Alarm Management, and Pest Control programs across internal Vertex CGT manufacturing sites.
- Support approval and extensions of CMMS work order records and supporting documents for preventive and corrective maintenance, instrument calibration, and system change management.
- Support quality event investigations involving out-of-tolerance calibration activities, including product impact evaluation, root cause analysis, and corrective actions.
- Support annual plant shutdowns and other planned area shutdowns, providing guidance on containment and controls to minimize impacts on cleanroom spaces.
- Provide technical support and strategy for facility return-to-service cleaning, testing, and GMP release.
- Oversee facility control programs, including qualified critical system monitoring and alarm systems such as the Environmental Monitoring System (EMS), and the pest control program.
- Partner with cross-functional teams to triage pest sightings and ensure timely responses or corrective actions meet Vertex standards.
- Review and approve monthly pest control logs, ensuring sightings are properly documented.
- Partner with cross-functional stakeholders to ensure periodic trend reports are completed and reviewed on time, emerging trends are identified and investigated, and corrective actions are implemented.
- Generate KPI monitoring metrics and communicate them to senior management and cross-functional stakeholders.
- Review and analyze program effectiveness, identifying gaps and opportunities for improvement.
- Participate in risk identification through gap analysis, corrective action planning, and risk communication.
- Foster cross-departmental collaboration to align project teams and resolve issues in a timely manner.
- Conduct biennial reviews and approvals of assigned departmental and cross-functional processes.
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What This Job Offers
Career Level
Mid Level
