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Quality Assurance Specialist I, Document Control and Training
Iovance Biotherapeutics, Inc.Quality Assurance Specialist supporting Iovance Biotherapeutics' document control and training program. Ensuring compliance with quality objectives and regulatory requirements.
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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
Comp & perks- Reasonable accommodations may be made upon request to enable individuals to perform essential functions.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
document managementdocument controltraining compliancequality assuranceGMPdocument change managementcompliance standardsattention to detailorganizational skillsprocess improvement
Soft Skills
interpersonal skillscommunication skillsorganizational skillsproblem-solvingtime management