About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com.
Job summary
The Temporary Quality Engineer I, Quality Data and Project Support provides hands-on quality engineering, quality systems, data analytics, and project coordination support for product development, pilot manufacturing, and commercialization-readiness activities. This position supports assigned Quality projects, including document creation and updates, record review, data organization and analysis, quality metrics, dashboard development, and follow-up on action items.
This role will assist with implementing and maintaining quality processes related to process changes, documentation updates, management review, quality metrics, data reporting, and general quality-system compliance. The Temporary Quality Engineer I will work cross-functionally with Engineering, Manufacturing, Quality Control, Information Technology, and other functions to help ensure that quality records and data are complete, accurate, traceable, timely, and compliant.
The position will also support Quality projects by coordinating working sessions, maintaining project plans and action trackers, documenting decisions, and escalating delays or risks. Project-management activities will be performed under the direction of Quality management or an assigned project lead.
This role requires strong attention to detail, analytical and technical capability, solid organizational skills, and the ability to work effectively in a fast-paced environment with shifting priorities. The position requires flexibility and willingness to support technical, analytical, project-related, and routine Quality tasks.
This role supports a quality system aligned with applicable medical-device and combination-product requirements, including FDA QMSR requirements under 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019, and applicable constituent-part requirements under 21 CFR Part 4.
Essential job functions and duties
- Support day-to-day quality engineering, quality systems, quality data, and project activities.
- Support preparation, review, and revision of SOPs, work instructions, forms, templates, and quality records.
- Review completed records for completeness, accuracy, data integrity, and compliance with applicable procedures.
- Collect, organize, clean, reconcile, and analyze quality and operational data from approved company systems and controlled sources.
- Develop, maintain, and improve quality metrics, reports, scorecards, dashboards, semantic models, and reporting architecture using tools such as Excel, Power BI, Power Automate, SharePoint, Python, SQL, or comparable applications. Design and optimize data models and reporting structures to support Quality processes and business decision-making.
- Develop automated reporting and workflow solutions that reduce manual data processing and improve quality-system efficiency.
- Support automated or scheduled extraction and transfer of data from MasterControl, ERP platforms, calibration and maintenance systems, spreadsheets, and other approved sources.
- Work with process owners to document data definitions, business rules, calculations, data sources, reporting requirements, and known limitations.
- Perform data-quality checks and assist with testing and reconciliation to confirm that reports and dashboards accurately reflect approved source data.
- Identify missing, duplicate, inconsistent, or potentially inaccurate information and coordinate resolution or escalation with applicable process owners.
- Support preparation of reports for Periodic Quality Management, Quality Management Review, process monitoring, and other management reporting.
- Prepare user instructions and provide support or training related to dashboards, reports, and routine data processes.
- Support manufacturing-related activities, including calibration and preventive-maintenance tracking for manufacturing, laboratory, inspection, and Quality equipment as assigned.
- Support equipment qualification, computerized-system assurance or validation, and IQ/OQ/PQ documentation as assigned.
- Support investigations, CAPAs, nonconformances, deviations, complaints, audits, supplier-quality activities, and process-improvement initiatives as needed.
- Assist with review of technical documentation, including specifications, drawings, test records, validation documents, risk-management records, and engineering or manufacturing changes.
- Support assigned Quality projects by maintaining schedules, deliverables, risks, dependencies, meeting records, and action-item trackers.
- Coordinate working sessions, document decisions and actions, follow up with owners, and escalate delays or compliance concerns.
- Maintain organized files, data, reports, and records within paper-based and electronic quality systems.
- Perform other duties as required to support Quality Assurance and quality-system operations.
Minimum requirements
- Bachelor's degree in Engineering, Computer Science, Data Science, Information Systems, Life Sciences, Quality, Statistics, or a related technical discipline.
- 0-2 years of relevant experience in quality, engineering, manufacturing, life sciences, or other technical environment, including professional, internship, academic-project, or cooperative-education (co-op) experience.
- Demonstrated ability to organize, analyze, and communicate technical or business data.
- Experience using Microsoft Excel for data organization, analysis, reconciliation, or reporting.
- Experience with at least one data-analysis, visualization, programming, database, or automation tool, such as Power BI, Power Automate, Python, SQL, Tableau, JMP, Minitab, or a comparable platform.
- Experience preparing clear technical documentation, instructions, presentations, or written summaries.
- Ability to learn and apply documented procedures, quality-system requirements, and data-governance expectations.
- Ability to manage multiple assignments and deliver accurate work within established timelines.
- Ability to work effectively with Quality, Engineering, Manufacturing, Information Technology, and other cross-functional teams.
- Strong attention to detail and willingness to perform both analytical and routine operational Quality tasks.
- Ability to identify data, documentation, project, or compliance concerns and escalate them appropriately.
- Proficiency in Microsoft Office applications, particularly Excel, Word, PowerPoint, Outlook, Teams, and SharePoint.
Disclaimer
INOVIO Pharmaceuticals, Inc. is an Equal Employment Opportunity Employer, including but not limited to veterans and individuals with disabilities. We prohibit discrimination of any kind. In keeping with our policy, we recruit, hire, train, and promote the most qualified individuals for all job titles, and we provide equal opportunities to all employees and applicants for employment.
A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.
Important notice to employment businesses/agencies
INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.