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Document Records Specialist

MAIN Duties and Responsibilities

Must be able to start immediately. Need someone ASAP.

Must have GMP and Bioscience background. 

Ensure documents are appropriately formatted as per our policies
Control circulation and tracking of documents starting from origination, revision, final signature and distribution.
Maintain database that tracts stages of documentation
Assign lot numbers and issue number to QA current versions of:

Production batch records, analytical records
Validation protocols/reports
Controlled forms

Ensure SOPs, BR, MS, FM, AM, PCA, PS (protocol and reports) are distributed and filed in a timely manner.
Issue all batch records, validation batch records, test methods, formulation methods, labels and cleaning methods for execution and assigning lot numbers. All records are issued directly to QA personnel.
Maintain all “quality records” in a secure manner. This includes raw data supporting GMP activity. For example – batch records, validation records, used log books, material specifications and release information.
Maintain accurate and timely document and record databases and logs.
Establish and control document templates.
Maintain up to date and accurate electronic and hard copy resources of active documentation as well as inactive and obsolete documentation.
Prep and issue logbooks / notebooks.
Scan and /or copy executed records and place in designated file (electronic file as well).
Coordinate and finalize compilation and preparation of executed records for document control archive storage.
Track, archive, retrieve and retain organized records (materials, equipment, manufacturing, testing, validation, vendor files, audit files, etc.).

i.Archive raw data

ii.Maintain data in organized manner for quick retrieval

Prepare records for off-site storage / archive – retrieve, return.
Prepare primary and secondary labels as needed.
Maintain admin supplies.
Maintain document control storage in orderly manner.


Note:  Perform assigned duties as assigned by the Quality Assurance Management.


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