Quality Assurance Document Control and Training Specialist I [Contract to Hire]

Overview

 The Quality Assurance Document Control and Training Specialist I is an onsite or hybrid position. This position is responsible for supporting the Quality Document Control and Training program and ensuring compliance to quality objectives and regulatory requirements.

Essential Functions and Responsibilities

·       Independently manage and monitor the processing, review, and approval of revision- controlled documents in the Electronic Document Management System (eDMS).

·       Provide user assistance and training on the eDMS.

·       Ensure compliance with controlled document format and content.

·       Maintain master documents and records (both hardcopy and electronic) to ensure documentation is retrievable

and files are accurate, complete, and well organized.

·       Manage the document periodic review process.

·       Provides support for internal and regulatory audits and inspections as required.

·       Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

·       Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

·       Independently manage and monitor the review and approval of training tasks in the Electronic Document Management System (eDMS).

·       Perform miscellaneous duties as assigned.

Travel – none required

Required Education, Skills, and Knowledge

·       Bachelor’s degree in Life Sciences discipline preferred, not required.

·       Minimum 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 and Excel.

·       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

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

·       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; and ability to meet deadlines

Work Environment

This job works in an onsite and/or home office space.  Requires operating standard office equipment and keyboards.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

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 careers@iovance.com.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 

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