GxP Document Control Specialist I

BioSpectra, Inc.; Bangor (Northampton County); On-site; USD 25,000 - 36,000; Full time

Job summary

BioSpectra, Inc. in Pennsylvania is seeking a Document Control Technician to manage daily document control in our Electronic Document Management System. The role supports Quality and Regulatory through data entry, archival, and master document setup across facilities in Bangor, Wind Gap and Stroudsburg.

The candidate will file, scan, and archive records, issue and track logbooks, and assist with MasterControl changes. A 2-year degree in a cGMP environment or equivalent experience is required.

Qualifications

• 2-year Associates Degree or approved equivalent experience in a cGMP environment.
• Understanding of cGMP & ICH-Q7.
• Strong knowledge of MS Office and Minitab.
• Knowledge of office systems and procedures.
• Organized, Thorough, Neat.
• Must be able to read, write, speak, and understand English.
• Confidentiality.

Responsibilities

• Assists with filing of company records and documents, including scanning, filing and retrieval.
• Initiates process for document archival when requested by system editors.
• Assists in data entry and analysis for Quality and Regulatory.
• Issues facility logbooks and ensures proper closure with new volumes.
• Tracks logbooks by location and volume; verifies proper issuance.
• Performs log book review for documentation errors and coordinates corrections.
• Manages shred bins per SOP for Record Storage Retention & Control.
• Binder creation and creation of controlled copies as requested.
• Supports Electronic Documentation System and basic MasterControl functions.
• Initiates new documents and information cards as requested by system editors.
• Other duties may be assigned by management.

Skills

cGMP & ICH-Q7

Office procedures

Organized

Neat

English reading/writing/speaking

Confidentiality

Education

Associate degree or approved equivalent experience in a cGMP environment

Tools

MS Office

Minitab

Job description

BioSpectra, Inc. in Pennsylvania is seeking a Document Control Technician to manage daily document control in our Electronic Document Management System. The role supports Quality and Regulatory through data entry, archival, and master document setup across facilities in Bangor, Wind Gap and Stroudsburg.

The candidate will file, scan, and archive records, issue and track logbooks, and assist with MasterControl changes. A 2-year degree in a cGMP environment or equivalent experience is required.