What are the responsibilities and job description for the QA Documentation Control Specialist position at Blue Ocean?
Overview:
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.
· 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 $80,000.00 per hour
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Work setting:
- In-person
Application Question(s):
- Proficient in EDMS (Electronic Document Management System) like SharePoint, Zoho Docs, DocuWare, Dropbox, Oneflow, etc.
Education:
- Bachelor's (Preferred)
Experience:
- Pharmaceutical: 2 years (Preferred)
- eDMS system: 2 years (Preferred)
- Quality control: 2 years (Preferred)
- Document management: 2 years (Preferred)
Work Location: In person
Salary : $80,000
