Senior Associate, Quality Assurance

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 Senior Quality Assurance Associate plays a critical role in ensuring compliance with applicable regulations and standards, including QSR, ISO, and MDD. This position supports daily QA operations, product flow, and documentation reviews. Responsibilities include managing Change Control, Temporary Deviation, Engineering Testing, and Validation systems. This role also ensures that documentation SOPs align with regulatory standards, overseeing document release and control processes. Strong computer skills and exceptional written and verbal communication abilities are required. Additionally, the associate assists in generating metrics for upper management review.

Essential job functions and duties

• Maintains documentation for Quality System, ensuring accuracy and compliance.
• Develop and update Standard Operating Procedures related to Quality System activities.
• Assists with Change Order processing and release activities, serving as a backup to the Document Control Manager.
• Communicate Change Order information and collaborate with Manufacturing, Engineering, Quality, Clinical and Research & Development.
• Ensure departmental records, Quality Management System procedures, and corporate/external standards (e.g., ISO 13485, Vigilance) comply with FDA Quality Systems Regulations (QSR) and applicable foreign regulations (e.g., Medical Device Directive).
• Provides administrative and technical support to the Quality Systems Associate Director in the investigations of product failures, adverse events, or field complaints, adhering to FDA, MDD/MDR, and ISO 13485 requirements.
• Assists in the review, tracking and trending of returns per company policies and regulatory requirements.
• Performs data input and document scanning into the computer system for data collection purposes used to identify quality trends.
• Performs other related tasks as assigned.

Minimum requirements

• Associate's degree (AA) or equivalent from two-year college or equivalent combination of education and experience. Bachelor's degree preferred.
• 3 - 5 years of experience in medical device or pharmaceutical/ biotech industry, with a solid understanding of FDA and ISO regulations.
• Ability to read, analyze, and interpret technical procedures and regulations, as well as write reports and procedure manuals.
• Strong communication skills with the ability to effectively present information and respond to inquiries from managers, clients, customers, and the general public.
• Ability to solve practical problems and navigate situations with limited standardization.
• Knowledge of Document Control and Change Order Processing principles.
• 3-5 years of experience in Document Control, Change Order processing, Deviations, Complaints, CAPA, and validation processes.
• Strong organizational and project management skills, with the ability to execute tasks in a disciplined and consistent manner.
• Ability to work independently with minimum supervision individually, as well as collaboratively in a team environment.

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.