Document Control Technician I

BioSpectra, Inc. is a privately held, family-oriented organization and a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including APIs, excipients, GMP process chemicals, and bulk GMP buffers and solutions. Our facilities are located in Bangor, Wind Gap, and Stroudsburg, PA.

About the role

The Document Control Technician is directly responsible for the daily Document Control functions in the Electronic Document Management System, supporting top pharmaceutical companies worldwide.

Responsibilities

• Assist with filing of company records and documents, including scanning, filing, and retrieval of filed items when requested.
• Maintain record retention and ongoing archival of documents in the Majestic library, Rockdale filing cabinets, and the McConnell filing cabinets.
• Initiate process for document archival when requested by system editors.
• Complete data entry and analysis as needed for the Quality and Regulatory Department.
• Issue facility logbooks when requested and ensure existing logbooks are closed out upon issuance of new ones.
• Track facility logbooks by location and volume issued; verify new logbooks are issued with the correct volume.
• Perform logbook review for documentation errors and corrections; coordinate with applicable departments for completion of corrections.
• Manage shred bins at BSI facilities by adhering to the Record Storage Retention & Control SOP.
• Create binders and controlled copies as requested.
• Support the Electronic Documentation System and users with basic MasterControl functions such as Change Requests and Set Effective.
• Initiate new documents as requested by system editors, including new Infocard creation and generation of document templates.
• Perform other duties as assigned by management.

Requirements

• 2-year Associate’s Degree or approved equivalent experience in a cGMP environment.
• Understanding of cGMP & ICH-Q7.
• Strong knowledge of relevant software applications including MS Office and Minitab.
• Knowledge of office systems and procedures.
• Organized, thorough, and neat.
• Must be able to read, write, speak, and understand English.
• Ability to maintain confidentiality.

Physical Requirements

• Lift up to 20 lbs. occasionally.
• Prolonged periods sitting at a desk and working on a computer.
• Repeating motion that may include wrists, hands, and fingers.

Schedule

• Non-Exempt Position: 8:00 AM to 4:30 PM.
• Minimum of 40-45 hours per week, or other agreed-upon documented schedule.
• Ability and willingness to work from all BioSpectra facilities.

Benefits

• Comprehensive benefits package including health, dental, vision, and life insurance ($50,000).
• 401K Retirement Savings Plan – Company matches $2 per $1 of employee contribution on the first 4%.
• Paid Time Off: 12 days vacation, 24 hours sick time, 16 hours personal time, plus 11 paid holidays.
• Tuition reimbursement for professional and personal development.