Associate Quality Control Specialist, Document Control [Contract to Hire]

Iovance Biotherapeutics•Philadelphia, PA

7h•Onsite

About The Position

The Associate Quality Control Specialist, 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

Must possess a high level of attention to details and have a strong quality mindset.
Must be organized
Highly motivated and a team player.
Ability to work effectively on multiple projects simultaneously and able to follow procedures and instructions.
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.
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.

Nice To Haves

Bachelor’s degree in Life Sciences discipline is preferred, but not required.
Strong computer skills including MS Office Suite.
Experience in archival and document change management is preferred, but not required.
Familiarity with cGMP, FDA regulations is preferred, but not required.

Responsibilities

Responsible for issuance of logbooks, protocols, and any applicable controlled documents.
Maintains the archival of GMP Ensures all GMP documents are complete, well organized, controlled, filed and tracked accurately in trackers and Electronic Document Management System (eDMS), if applicable, and easily retrievable.
Independently manage, process, review, and approve the archival of documents in the eDMS.
Provides user assistance on eDMS
Provides support for internal and regulatory audits and inspections as required.
Responsible for basic problem solving related to job responsibilities.
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.
Performs 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, etc.).
Perform other duties assigned by the area management, which may or may not be associated with projects. Based on business needs, training on document and label issuance for Manufacturing department and, cross-training and assisting other teams within Quality Assurance department may be required.