Address
Form of work
SalaryOverview
This position is responsible for supporting the Quality Document Control program at the iCTC facility and ensuring compliance to quality objectives and regulatory requirements.
Essential Functions and Responsibilities
- Independently manage and monitor the processing, review, and approval of revision- controlled documents in the Electronic Document Management System (eDMS).
- Provide user assistance and training on the eDMS.
- Ensure compliance with controlled document format and content.
- Maintain master documents and records (both hardcopy and electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized.
- Manage the document periodic review process.
- Issuance of batch records, forms, logbooks, validation documents, labels, and other controlled documents as required.
- Provides support for internal and regulatory audits and inspections as required.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Job Type: Full-time
Salary: From $75,000.00 per hour
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Application Question(s):
- What are the Electronic Document Management System (eDMS) experience do you have?
Education:
- Bachelor's (Preferred)
Experience:
- Quality assurance: 2 years (Preferred)
- Electronic Document Management System (eDMS): 2 years (Preferred)
Work Location: In person
