[Hiring] Quality Assurance Specialist I, Document Control and Training @Iovance Biotherapeutics

Role Description

This position is responsible for supporting the Quality Document Control and Training program and ensuring compliance to quality objectives and regulatory requirements.

• Independently manage and monitor the processing, review, approval, archival, and distribution of revision-controlled documents in the Electronic Document Management System (eDMS).
• Provide user support and guidance on document workflows, processes, and system usage.
• Ensure documents meet formatting, content, and compliance standards prior to approval.
• Maintain document records to ensure accuracy, completeness, and traceability within the system.
• Coordinate document periodic reviews of controlled documents to ensure ongoing accuracy and compliance.
• Support internal and external inspections by retrieving documentation and ensuring inspection readiness.
• Independently manage training assignments and task execution within the Electronic Document Management System (eDMS).
• Generate and distribute training compliance reports for management and audit purposes.
• Support onboarding training activities and assignment of required curriculum.
• Identify and escalate process inefficiencies within document control and training workflows.
• Perform miscellaneous duties as assigned.

Travel – none required

Qualifications

• Bachelor’s degree in Life Sciences discipline preferred, not required.
• Two (2) years in QA training and documentation in pharmaceutical or biopharmaceutical GMP based facility. Experience in other areas of Quality (Quality Operations and/or Quality Systems) is a plus.
• Must possess a high level of attention to detail and proficient in Word.
• Strong computer, organizational, and compliance skills.
• Proficient in an eDMS/eLMS system (specifically MasterControl). Experience as MasterControl System Administrator or MasterControl Document Control Administrator is a plus.
• Familiarity with document change management and FDA quality systems.
• Ability to work effectively on multiple projects simultaneously with minimum supervision.
• Strong interpersonal and communication skills.

Requirements

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental

• Clear and conceptual thinking ability.
• Excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
• Ability to handle work-related stress.
• Ability to handle multiple priorities simultaneously.
• Ability to meet deadlines.

Work Environment

This job works in a home office space. Requires operating standard office equipment and keyboards.

Pay Transparency

The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.

$40 — $42 USD

Company Description

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

If you need assistance or accommodation to apply to one of our opportunities, please contact [email protected] .