Document Control Technician I

Document Control Technician

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.

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 editors.
• 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 Infocard 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