Quality Assurance Specialist I, Document Control and Training
New
I
Iovance BiotherapeuticsBiopharmaceutical
RemoteContractEntry
Salary40 - 42 USD per hour
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Job Details
- Experience
- Two (2) years
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s degree in Life Sciences discipline preferred.
- Two (2) years in QA training and documentation in pharmaceutical or biopharmaceutical GMP based facility.
- Proficient in an eDMS/eLMS system (specifically MasterControl).
- Familiarity with document change management and FDA quality systems.
- Strong interpersonal and communication skills.
- High level of attention to detail.
- Proficient in Word.
- Strong computer, organizational, and compliance skills.
Responsibilities
- 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 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.
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