Quality Assurance Document Control Specialist I [Contract to Hire]

Iovance Biotherapeutics • Philadelphia, PA

4d • Onsite

About The Position

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: Wednesday to Saturday from 9am to 8pm

Requirements

• 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
• 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.
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees