Documentation Specialist

3 weeks ago

Melrose Park, United States Integrated Resources, Inc ( IRI ) Full time

POSITION SUMMARY

Responsible for classifying, filing and retrieving a wide variety of documents maintained in the Central File. Performs data entry and referencing for computerized record tracking and maintains database recordkeeping system. Ensures that all users of Central File comply with policies and practices for appropriate record handling and maintenance.

JOB DESCRIPTION

• Classifies a wide range of technical documents received by Central File including Production Batch Records, Validation/Qualification protocols, CWOs (Critical Work Orders), testing and release records for incoming chemical raw materials, Stability test records, Laboratory Notebooks and reports for numerous facility systems, equipment and instruments, facility log books documenting manufacturing process, operation and maintenance of equipment, etc. Other documents include FDA historical records of contracts, inspections, responses to observations, all of which are critical to substantiate and demonstrate positive compliance status of the manufacturing facility.

• Performs subject technical indexing function by assigning appropriate document identification using database for storage and retrieval.

• Indexes and archives documents received at the Central File for secure storage.

• Provides input on preparation and writing of SOPs for the Central File and assists in ongoing revision/update of such procedures.

• Assigns priorities for and provides timely retrieval of records requested.

• Establishes and manages the retention schedule for older, inactive files, determines when documents are transferred for off-site archival storage.

• Accurately maintains Central File Database Index of validations and STAD reports.

• Assures proper organization and housekeeping of Central File areas at all times.

• Ensures the integrity and security of all Central File documents and filing areas.

• Coordinates the receipt of all manufacturing documents and product testing reports.

REQUIREMENTS

• High school graduate with some college preferred.

• 3-5 years experience in the pharmaceutical industry.

• Knowledge of computerized record tracking systems.

• Good knowledge of validation and manufacturing processes with experience in handling associated controlled documents.

• Excellent organizational skills required.

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