Overview:
This position is responsible for supporting the Quality Document Control program and ensuring compliance to quality objectives and regulatory requirements for the site 2nd shift. In addition, this position will be responsible for providing training on the company eDMS.
Job Responsibilities:
- Manage and monitor the processing, review, and approval of revisionโcontrolled documents in the Electronic Document Management System (eDMS) with minimal supervision.
- 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.
- Provide user assistance, training, and continuous feedback on eDMS
- Responsible for ensuring documents are retained per record retention policies and procedures.
- Provide support for internal and regulatory audits and inspections.
- Adhere to GMP, SOPs, and GDP
Job Qualifications:
- Bachelor's degree in Life Sciences discipline preferred
- At least 5 years of experience within quality assurance document control working within a GMP environment
- Proficient with document change management and FDA quality systems.
- Proficient in an eDMS (specifically MasterControl).
- Strong computer, organizational, and compliance skills
- Ability to work effectively on multiple projects simultaneously with minimum supervision.
