Specialist, Facilities Operations QA (Contract)

Atrium Works•Boston, MA

2d•Onsite

About The Position

This contract role provides quality assurance oversight and support for facilities and engineering operations across Vertex CGT manufacturing sites. The position ensures tactical execution of program requirements complies with Vertex standards and procedures, with a focus on facilities and equipment preventive maintenance and calibration, critical alarm management, and pest control. The role is based on site at the Jeffrey Leiden Center, Monday through Friday. The Specialist supports work-order and supporting-document approvals, quality event investigations, shutdown activities, facility control programs, and cross-functional quality initiatives. Responsibilities also include monitoring program effectiveness, supporting metrics and trend reviews, identifying risks and improvement opportunities, and reviewing assigned processes for continuous improvement. This is a temporary assignment through a third-party agency partner. The selected individual will be employed by the agency partner, which will provide compensation, medical benefits, fringe benefits, and other employment terms. The stated pay range is $60–$65 per hour, and the role is eligible for overtime pay in accordance with federal and state requirements.

Requirements

Master’s degree and 3–5 years of relevant work experience, or a bachelor’s degree in engineering, a scientific field, or an allied health field and a minimum of 8 years of relevant work experience, or a relevant comparable background.
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.
Demonstrated ability to communicate effectively and influence decision-making outcomes.
Ability to thrive in a high-throughput environment.
Proficiency with project-management processes and tools to lead meetings, assist with project planning, and facilitate task completion.
Strong collaboration, teamwork, and conflict-management skills.
Ability to transfer technical knowledge and teach skills to junior staff.
Ability to influence others within the technical area of expertise and communicate across organizational levels.
Critical-thinking and problem-solving skills, including the ability to evaluate quality matters and make risk-based decisions.
Flexibility, adaptability, and attention to detail.
Ability to work independently and provide QA support for large, multifaceted projects.
Availability to provide on-site support Monday through Friday at the Jeffrey Leiden Center.

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 associated documentation for preventive and corrective maintenance, instrument calibration, and system change management.
Support investigations of out-of-tolerance calibration activities, including product-impact evaluation, root-cause analysis, and corrective actions.
Support annual plant shutdowns and other planned area shutdowns, advising on containment and controls to minimize cleanroom impact and providing technical support for return-to-service cleaning, testing, and GMP release.
Oversee facility control programs, including the qualified critical-system monitoring and alarm system (EMS) and pest control program.
Partner with cross-functional teams to triage pest sightings and ensure timely responses and corrective actions meet Vertex standards.
Review and approve monthly pest-control logs, ensuring sightings are properly documented.
Coordinate periodic trend reports with cross-functional partners, identify and investigate emerging trends, and ensure robust corrective actions are implemented.
Support generation of KPI 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, determination of corrective actions, and risk communication.
Foster cross-departmental collaboration in project teams to align stakeholders and resolve issues on time.
Conduct biennial review and approval of assigned department and cross-functional processes to support continuous improvement.