Document Control Technician I — GMP & Growth Opportunity

Biospectra Inc; Bangor (ME); On-site; USD 42,000 - 48,000; Full time

Benefits offered by this job

401K Retirement Savings Plan

Tuition reimbursement

Growth opportunities

Job summary

BioSpectra, Inc. in Bangor, PA is seeking a Document Control Technician to manage daily document control in the Electronic Document Management System and support quality and regulatory activities.

You will file records, maintain archives across facilities, create controlled copies, and assist with MasterControl functions, with standard hours 8:00–16:30 and a 40–45 hour week. This role requires a 2-year Associate degree in a cGMP environment and strong English proficiency.

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.
• 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 data entry and analysis for Quality and Regulatory Department.
• Issues facility logbooks and ensures old logbooks are closed out.
• Tracks facility logbooks by location and volume; issues new logbooks with correct volume.
• Performs Log Book review for documentation errors and correction and coordinates with applicable departments.
• Manages shred bins at BioSpectra facilities per SOP.
• Binder Creation.
• Creates controlled copies as requested.
• Supports the Electronic Documentation System and users with MasterControl (Change Requests, Set Effective).
• Initiates new documents, including lnfocard creation and document templates.
• Other duties as assigned by management.

Skills

cGMP knowledge

ICH-Q7 knowledge

MS Office

Minitab

Office systems

English proficiency

Organized

Confidentiality

Education

Associate degree

Tools

MS Office

Minitab

Job description

BioSpectra, Inc. in Bangor, PA is seeking a Document Control Technician to manage daily document control in the Electronic Document Management System and support quality and regulatory activities.

You will file records, maintain archives across facilities, create controlled copies, and assist with MasterControl functions, with standard hours 8:00–16:30 and a 40–45 hour week. This role requires a 2-year Associate degree in a cGMP environment and strong English proficiency.