-
ID
#22061382 -
Job type
Contract -
Salary
TBD -
Source
Manpower Engineering -
Date
2021-11-02 -
Deadline
2021-12-31
QA Document Control Specialist
Massachusetts, Chelsea, 02150 Chelsea USAContract
Vacancy expired!
- Facilitates the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.) by functioning as a document workflow coordinator.
- Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, distributions and archiving.
- Provides day-to-day support of the electronic document management system (EDMS), and operational controls to maintain the validated state (compliance with 21 CFR Part 11)
- Collaborates with team to identify opportunities for process improvement in the Document Control program and works cross functionally to implement, as appropriate.
- May assist with end-user training for new users of the EDMS and document control business processes.
- Participates in Standard Operating Procedures generation and review.
- Provides day-to-day operation support for client groups (e.g. scheduling, reporting, records archiving)
- Assist with metrics generation of monthly periodic reviews for Quality management Supports audits and/or regulatory inspections.
- Other duties may be assigned. Facilitates the archival of GMP documentation and records:
- Prepares and inspects documents for scanning operations, scans and re-assembles documents
- Conducts quality assurance tests to ensure images meet quality standards; appends or correct images in response to quality assurance findings.
- Uploads electronic records into the Electronic Document Management System (EDMS).
- Files and organizes archival records and develops classification systems to facilitate access to archived records.
- Coordinates the transfer of records with document storage facilities; manages record classifications and storage location in the Record Management System (RMS).
- Ensures records are maintained according to regulatory requirements including quality checks.
- Supports and participates in internal and external audits as requested. Provides operational support to the GMP Training Program, as needed:
- Maintain employee training files/database or LMS
- Processes training files by reviewing data for deficiencies; resolving discrepancies by using standard procedures or returning incomplete training files to the team leader for resolution.
- May assist with end-user training of the LMS and user creation
- Ensures employee training documentation is in accordance with regulatory requirements. others.
- Demonstrates attention to detail.
Vacancy expired!
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