Document Control Technician 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. is a privately held, family-oriented organization and a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including API’s, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra currently has facilities located in Bangor, Wind Gap, and Stroudsburg, PA.

Why you should join BioSpectra?

• 401K Retirement Savings Plan – Company matches $2 per $1 of employee contribution on the first 4%
• Opportunities for professional and personal development & growth include tuition reimbursement
• Support our current customers who are the top 25 pharmaceutical companies in the world

Job Summary:

The Document Control Technician is directly responsible for the daily Document Control functions in the Electronic Document Management System.

Essential Duties and Responsibilities:

• Assists with filing of company records and documents as needed, 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.
• Initiates process for document archival when requested by system editers.
• Assists in the completion of data entry and analysis as needed for the Quality and Regulatory Department.
• Issues facility logbooks when requested and ensures existing logbooks are closed out upon issuance of new ones.
• Tracks facility logbooks by location and volume issued. Ensures new logbooks are issued and verified with the correct volume.
• Performs Log Book review for documentation error and correction and coordinates with applicable departments for the completion of the corrections.
• Manages the shred bins at BSI facilities by adhering to the Record Storage Retention & Control SOP.
• Binder Creation
• Creates controlled copies as requested
• Supports the Electronic Documentation System and users with basic MasterControl functions such as Change Requests and Set Effective.
• Initiates new documents as requested by system editors, including new lnfocard creation and generation of a document template.
• Other duties may be assigned as deemed appropriate by management

Qualifications:

• 2-year Associates 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, Neat
• Must be able to read, write, speak, and understand English
• 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

Work Hours:

• Non-Exempt Position: 8am to 4:30pm
• Minimum of 40-45 Hours Week, or other agreed upon documented schedule
• Ability and willingness to work from all BioSpectra facilities