Specialist, Facilities Operations QA;

Duties include QA oversight of Facility and Equipment Preventive Maintenance and Calibration programs, and facility control programs such as Critical Alarm Management, and Pest Controls programs. Review of work orders, Facility related CAPAs and Deviations.

Key Duties and Responsibilities Operations – Facilities and Engineering Operations Support:

• Monday-Friday On Site Support at Jeffrey Leiden Center
• Responsible for providing quality oversight and support ensuring the tactical execution of program requirements are compliant with Vertex standards and procedures across all internal Vertex CGT manufacturing sites for the following:
  • Facilities and Equipment Preventive Maintenance and Calibration Program
  • Critical Alarm Management
  • Pest Control Program

Facilities and Equipment Preventive Maintenance and Calibration Program:

• Support the approval and extensions of CMMS work order records and associated supporting documents for preventive/corrective maintenance, instrument calibration, and system change management records.
• Support quality event investigations of out-of-tolerance calibration activities ensuring robust product impact evaluation, effective root cause analysis and corrective actions.
• Support annual plant shutdown and other planned area shutdown activities, including providing guidance on containment and other controls to minimize impact on cleanroom spaces, provide technical support and strategy for return to service cleaning, testing, and GMP release of the facility
• Facility Control Programs (Critical Alarms Management and Pest Control Program)
• Provide oversight for the facility control programs, including the qualified critical system monitoring and alarm system (Environmental Monitoring System, EMS), and pest control program.
• Partner with cross-functional team to support triage of pest sightings ensuring immediate response and/or corrective actions meet Vertex standards. Review and approve monthly pest control logs ensuring sightings are properly documented
• Partner with cross-functional partners to ensure periodic trend reports are completed and reviewed on time, any emerging trends are identified and investigated, and robust corrective actions are implemented.

General Quality Support:

• Support the generation of metrics for monitoring KPI and communicating those to senior management and cross-functional stakeholders.
• Review/analyze the effectiveness of the program, identifying gaps and opportunities for improvement.
• Participate in risk identification by performing gap analysis, determining robust corrective actions, and risk communication.
• Foster cross-departmental collaboration within project teams to ensure alignment and timely resolution of issues.
• Responsible for biennial review and approval of assigned department and cross functional processes for continuous improvement.

Knowledge and

Skills:

Key Leadership

Skills:

• Cross- functional collaborator
• Results Driver

Key Knowledge/ Skills and

Competencies:

• Ability to thrive in a high throughput environment
• Proficiency utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
• Collaboration / Teamwork / Conflict Management
• Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff
• Ability to effectively influence others within technical area of expertise
• Ability to communicate effectively across all organizational levels
• Critical Thinking / Problem Solving
• Ability to evaluate quality matters and make decisions utilizing risk based approach
• Flexibility/Adaptability
• Attention to detail
• Demonstrated ability to work independently to provide QA support for large, multifaceted projects

Education and Experience:

• Demonstrated ability to effectively communicate and influence the outcomes of the decision-making process
• Experience successfully leading quality review of event investigations, Root Cause Analysis (RCA), and CAPA
• Experience with equipment, facilities and utility system qualifications 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 engineering, scientific or allied health field with minimum 8 years of relevant work experience, or relevant comparable background.

Pay Range

$60-$65/HR

Shift/Hours

Monay - Friday

No C2C or Third-Party Vendors