Manufacturing Quality/Documentation Associate

Infotree Global Solutions

Frederick (MD)

On-site

USD 42,000 - 66,000

Full time

2 days ago
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Job summary

Infotree Global Solutions is seeking a Manufacturing Document Control Associate to ensure accurate retrieval, scanning, organization, and electronic uploading of GMP documentation within the company’s DMS. The role supports compliance with GMP and company procedures and maintains batch records and production logs.

Responsibilities include reviewing documents for completeness and accuracy, indexing and storing records, and assisting QA and manufacturing with document requests in a timely manner.

Qualifications

  • High school diploma or equivalent.
  • 2+ years in the pharmaceutical industry, preferably in manufacturing or quality roles.
  • Experience with GMP documentation and controls.
  • Experience with scanning, data entry, and electronic document management.
  • Familiarity with DMS and batch records.

Responsibilities

  • Retrieve, collect, and organize manufacturing documentation.
  • Scan and electronically upload records into the DMS.
  • Review documents for completeness, accuracy, and legibility.
  • Maintain and archive batch records and GMP documentation.
  • Ensure proper indexing, naming, and storage of documents.
  • Support record retrieval requests for QA and production.
  • Follow SOPs and GMP requirements.

Skills

Data entry
Document management
GMP compliance
Electronic document management systems
Batch documentation
Quality Assurance support

Education

High school diploma or equivalent

Tools

DMS software
Scanning equipment
Electronic scanning tools

Job description

The Manufacturing Document Control Associate is responsible for the accurate retrieval, scanning, organization, tracking, and electronic uploading of manufacturing and production records using the company’s Document Management System (DMS). This role ensures that documentation is complete, properly maintained, and readily available while supporting compliance with Good Manufacturing Practices (GMP) and company procedures.

Key Responsibilities:

  • Retrieve, collect, and organize manufacturing and production documentation.
  • Scan and electronically upload production records into the company’s Document Management System.
  • Review documents for completeness, accuracy, legibility, and proper organization.
  • Maintain and archive batch records, logbooks, production records, and other GMP documentation.
  • Ensure documents are properly indexed, named, and stored according to established procedures.
  • Support document retrieval requests and provide records to manufacturing, Quality Assurance, and other departments as needed.
  • Maintain accurate document filing systems and ensure timely processing of records.
  • Follow company SOPs, document control procedures, and GMP requirements.

Required Qualifications:

  • High school diploma or equivalent.
  • 2+ years of experience in the pharmaceutical industry, preferably in manufacturing, document control, quality, or production support.
  • Experience handling and maintaining GMP documentation.
  • Experience with scanning, electronic document management, data entry, and document retrieval.
  • Experience working with electronic Document Management Systems (DMS) preferred.
  • Familiarity with pharmaceutical manufacturing processes and GMP requirements.
  • Experience with batch documentation, manufacturing logbooks, and controlled records.
  • Previous experience supporting Quality Assurance or manufacturing operations.
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