Quality Assurance Document Control Specialist I [Contract to hire]

Overview

The Quality Assurance Document Control Specialist (QADC), Level I is located at Iovances Cell Therapy Center (iCTC) in Philadelphia PA. This position is responsible for supporting the Quality Document Control program at the iCTC facility and ensuring compliance to quality objectives and regulatory requirements. The individual must be qualified, highly motivated, detail oriented, and a team player.

Essential Functions and Responsibilities

• Independently manage and monitor the processing, review, and approval of the archived documents in the Electronic Document Management System (eDMS).
• Maintain master documents and records (both hardcopy and electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized.
• Provide user assistance on eDMS.
• Ensure compliance with controlled document format and content.
• Assists with maintaining Quality Assurance Document Control tracking tools for metrics purposes.
• Issuance of Patient and Non-Patient lot batch records, in-process product labels to Manufacturing according to ICTC Master Production schedule.
• Issuance of logbooks, protocols, and other controlled documents upon request.
• Provides support for internal and regulatory audits and inspections as required.
• Provides continuous feedback on improvements to Document Control processes. Escalates issues or concerns to Area Management.
• Comply with Safety SOPs and laboratory procedures per company policy.
• Must adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel none required

Preferred Education, Skills, and Knowledge

• Bachelors degree in Life Sciences discipline preferred but not required.
• Two (2) years demonstrating MS Office Suite and Archival skills.
• Proficient in an eDMS system and document formatting.
• Must possess a high level of attention to detail.
• Strong computer, organizational, and compliance skills.
• 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 accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Able to stand and/or walk in a 10-hr day which may include climbing ladders or steps.
• Must be able to move about inside an office and exert up to 30 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, safety glasses, etc.
• 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 a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. 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 individuals 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

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