Document Control Technician I – Pharma Records & Compliance

Biospectra Inc; False Pass (AK); On-site; USD 42,000 - 65,000; Full time

Benefits offered by this job

Health, Dental, Vision, & Life보험

401K with company match

Paid time off: vacation, sick, andfif

Tuition reimbursement

Professional development

Work with top global pharmaceuticals

Job summary

BioSpectra, Inc is seeking a Document Control Technician to manage daily document control in the Electronic Document Management System across BioSpectra facilities. You will file records, scan, retrieve documents, and maintain archival systems.

Responsibilities include data entry for Quality and Regulatory, managing logbooks, coordinating document corrections, supporting MasterControl, creating new documents, and ensuring controlled copies are issued.

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.
• Read, write, speak and understand English; maintain confidentiality.

Responsibilities

• Assist with filing and archival of company records; scan, file and retrieve items as requested.
• Maintain record retention and archival of documents in designated libraries and cabinets.
• Support data entry and analysis for Quality and Regulatory.
• Manage facility logbooks, issue and verify volumes, and close out old logs.
• Coordinate document corrections and communicate with departments.
• Support MasterControl functions such as Change Requests and Set Effective.
• Create controlled copies and initiate new documents per system editors.

Skills

cGMP knowledge

ICH-Q7

Organized

Neat

Confidentiality

English proficiency

Education

Associates degree or approved equivalent in cGMP

Tools

MS Office

Minitab

Job description

BioSpectra, Inc is seeking a Document Control Technician to manage daily document control in the Electronic Document Management System across BioSpectra facilities. You will file records, scan, retrieve documents, and maintain archival systems.

Responsibilities include data entry for Quality and Regulatory, managing logbooks, coordinating document corrections, supporting MasterControl, creating new documents, and ensuring controlled copies are issued.