Documentation Specialist

4 weeks ago


Melrose Park, United States Acro Service Corporation Full time
Job DescriptionJob Description

We are seeking a Documentation Specialist to join the company, a premier supplier, in Melrose Park, IL While working in this clean, not climate-controlled facility you will have the opportunity to be directly involved in the evolution of the industry. Come work for a company that has been consistently recognized among the Best & Brightest Companies to Work For. Immediate interviews are available, apply today

Job Title: Documentation Specialist

Duration-  9 Weeks

Pay rate: $25/hr

Location: Melrose Park, IL

 

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.

The Company is an Equal Opportunity Employer and is committed to creating an equitable and inclusive environment for all.

Company DescriptionWith almost four decades of experience as a proven industry leader, Acro continues to be consistently recognized among the Best & Brightest Companies to Work for in the United States. As an international professional services firm with deep expertise in consulting and staff augmentation offering a variety of solutions including MSP, VMS, RPO, HRO (and more), Acro operates across North America, Europe, and Asia from over 30 locations. Acro’s client portfolio includes some of the most well-known names in business and provides services across all verticals including technology, aerospace, energy, automotive, government, and manufacturing. To learn more, please visit www.acrocorp.com.Company DescriptionWith almost four decades of experience as a proven industry leader, Acro continues to be consistently recognized among the Best & Brightest Companies to Work for in the United States. As an international professional services firm with deep expertise in consulting and staff augmentation offering a variety of solutions including MSP, VMS, RPO, HRO (and more), Acro operates across North America, Europe, and Asia from over 30 locations. Acro’s client portfolio includes some of the most well-known names in business and provides services across all verticals including technology, aerospace, energy, automotive, government, and manufacturing. To learn more, please visit www.acrocorp.com.
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