Quality Assurance Document Control Specialist 1

Overview

The Quality Assurance Specialist I, Document Control is located at Iovance Cell Therapy Center (iCTC) in Philadelphia, PA. This position requires full-time on-site presence. This position is responsible for supporting the Quality Document Control program at the iCTC facility and ensuring compliance to quality objectives and regulatory standards. The individual must have a strong quality mindset.

Shift: Sunday to Wednesday from 9am to 8pm

Essential Functions and Responsibilities

•Responsible for issuance of unique identifier/lot number for identification and traceability of Patient and Non-Patient Manufacturing Lots.
•Performs the issuance of Patient and Non-Patient batch records and required forms.
•Generates and issues in-process labels for both Patient and Non-Patient Lots.
•Supports the day-to-day need of Manufacturing, QC, and other departments at iCTC.
•Must be proficient in Associate Level responsibilities to serve as a back-up, as needed. This includes logbooks and controlled copy issuance, and archival.
•Independently manage, process, review, and approve the archival of documents in the Electronic Document Management System (eDMS).
•Provide user assistance on eDMS
•Responsible for problem solving related to job responsibilities.
•Provides support for internal and regulatory audits and inspections as required.
•Assists with maintaining Quality Assurance Document Control tracking tools for metric purposes.
•Provides continuous feedback on improvements to Document Control processes.
•Escalates issues or concerns to Area Management
•Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
•Perform miscellaneous duties required to complete the responsibilities stated in this Job Description (i.e. maintaining inventory of supplies and purchasing, maintaining the work area tidy, attend meetings, etc.).

•Perform other duties assigned by the area management, which may or may not be associated with projects.

Travel – none required

Preferred Education, Skills, and Knowledge

Bachelor’s degree in Life Sciences discipline is required.
•Minimum of two (2) years of experience in document change management and archival or advanced degree without experience.
•Minimum of two (2) years of experience in cGMP, FDA regulated industry is required.
•Strong computer skills including MS Office Suite
•Must possess a high level of attention to details and have a strong quality mindset.
•Must be organized
•Must be qualified, highly motivated, and a team player.
•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.
•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 comply with Safety SOPs and laboratory procedures per the company policy.
•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.

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