Quality Assurance Document Control Specialist I [Contract to Hire] jobs in United States
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Iovance Biotherapeutics, Inc. · 1 day ago

Quality Assurance Document Control Specialist I [Contract to Hire]

Iovance Biotherapeutics is focused on cell therapy and is seeking a Quality Assurance Specialist I, Document Control. The role involves supporting the Quality Document Control program, ensuring compliance with quality objectives, and performing various documentation tasks related to manufacturing and quality control.

BiotechnologyClinical TrialsHealth CareHealth DiagnosticsMedical
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H1B Sponsor Likelynote

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

Qualification

CGMP experienceFDA regulated industry experienceDocument change managementElectronic Document Management SystemMS Office SuiteAttention to detailOrganizational skillsTeam playerInterpersonal skillsCommunication skills

Required

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

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