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

Iovance Biotherapeutics•Philadelphia, PA

1d•Onsite

About The Position

Overview 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. Essential Functions and 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. Travel – none required Preferred Education, Skills, and Knowledge 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. Must possess a high level of attention to details and have a strong quality mindset. Must be organized Familiarity with cGMP, FDA regulations is preferred, but not required. 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. 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. #LI-onsite 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 [email protected] . 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 .

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.
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.