Iovance Biotherapeutics, Inc. logo
Iovance Biotherapeutics, Inc.

Iovance is a patient-centric, collaborative organization that is driven to change the way cancer is treated.

Quality Assurance Specialist I, Document Control and Training

QA EngineerQA EngineerContractRemoteMid LevelTeam 501-1,000Since 2014H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

5 days ago

Salary

$40K - $42K / year

Seniority

Mid Level

Bachelor Degree2 yrs expExperience acceptedEnglish

Job Description

Quality Assurance Specialist I, Document Control and Training

Iovance Biotherapeutics, Inc.

• Independently manage and monitor the processing, review, approval, archival, and distribution of revision- controlled documents in the Electronic Document Management System (eDMS). • Provide user support and guidance on document workflows, processes, and system usage. • Ensure documents meet formatting, content, and compliance standards prior to approval. • Maintain document records to ensure accuracy, completeness, and traceability within the system. • Coordinate document periodic reviews of controlled documents to ensure ongoing accuracy and compliance. • Support internal and external inspections by retrieving documentation and ensuring inspection readiness. • Independently manage training assignments and task execution within the Electronic Document Management System (eDMS). • Generate and distribute training compliance reports for management and audit purposes. • Support onboarding training activities and assignment of required curriculum. • Identify and escalate process inefficiencies within document control and training workflows. • Perform miscellaneous duties as assigned.

Job Requirements

  • Bachelor’s degree in Life Sciences discipline preferred, not required.
  • Two (2) years in QA training and documentation in pharmaceutical or biopharmaceutical GMP based facility. Experience in other areas of Quality (Quality Operations and/or Quality Systems) is a plus.
  • Must possess a high level of attention to detail and proficient in Word and
  • Strong computer, organizational, and compliance skills
  • Proficient in an eDMS/eLMS system (specifically MasterControl). Experience as MasterControl System Administrator or MasterControl Document Control Administrator is a plus.
  • Familiarity with document change management and FDA quality systems
  • Ability to work effectively on multiple projects simultaneously with minimun
  • Strong interpersonal and communication skills.

Benefits

  • Reasonable accommodations may be made upon request to enable individuals to perform essential functions.

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