Associate Quality Control Specialist, Document Control [Contract to Hire] jobs in United States
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Iovance Biotherapeutics, Inc. · 18 hours ago

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

Iovance Biotherapeutics is seeking an Associate Quality Control Specialist, Document Control at their Cell Therapy Center in Philadelphia, PA. The role involves supporting the Quality Document Control program, ensuring compliance with quality objectives and regulatory standards, and managing the archival of documents in the eDMS.

BiotechnologyClinical TrialsHealth CareHealth DiagnosticsMedical
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H1B Sponsor Likelynote

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

Qualification

Document ControlEDMSCGMPFDA regulationsMS Office SuiteAttention to detailOrganizational skillsInterpersonal skillsCommunication skills

Required

Strong quality mindset
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
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

Preferred

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
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

Company

Iovance Biotherapeutics, Inc.

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Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer.

H1B Sponsorship

Iovance Biotherapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (11)
2023 (7)
2022 (7)
2021 (2)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$1.58B
2024-02-20Post Ipo Equity· $211M
2023-07-10Post Ipo Equity· $150M
2020-05-27Post Ipo Equity· $603.7M

Leadership Team

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Jean-Marc Bellemin
Chief Financial Officer
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Cheryl Aranda
Executive Assistant to Chief Medical Officer
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Company data provided by crunchbase