Detail-Oriented Document Control Associate - GMP/GDP

Virtue America; Pennsylvania; On-site; USD 42,000 - 54,000; Full time

Job summary

Virtue America seeks a detail-oriented Entry-Level Document Control Specialist to support document management and quality documentation within pharma/biotech operations. You will assist with SOPs, records, and controlled documents, ensuring accuracy and regulatory compliance.

Responsibilities include reviewing documents, maintaining DMS/eQMS systems, managing version control, and coordinating with QA, QC, and other departments to ensure proper approvals and archiving.

Qualifications

• Bachelor's or Master’s degree in pharmaceutical/biotech life sciences.
• Familiarity with GMP and GDP and regulatory documentation requirements.
• Proficiency in Microsoft Office (Word, Excel).
• Knowledge of document management practices and controlled documentation.

Responsibilities

• Assist in receiving, reviewing, organizing, maintaining, and tracking controlled documents including SOPs, policies, forms, protocols, and reports.
• Check documents for completeness, formatting accuracy, version details, approval information, and compliance with standards.
• Maintain and update document records using DMS/eQMS.
• Track revisions, maintain revision histories, and ensure latest approved versions are available.
• Support SOP preparation, routing, review, approval, distribution, and periodic revision.
• Coordinate distribution of approved documents and withdraw outdated versions.
• Maintain quality records including deviations, CAPA documentation, change controls, audits, validation documents, and training records.
• Follow GMP, GDP, and regulatory guidelines when handling controlled documents.
• Maintain electronic records, metadata, approval records, access permissions, and audit trails.
• Archive and retain documents per retention policies.
• Retrieve documentation for internal and external audits and inspections.
• Maintain training records and assist in SOP updates and training documentation.
• Coordinate with QA, QC, Manufacturing, Engineering, Regulatory Affairs for document collection and approvals.

Skills

Document management

Quality documentation

Excellent attention to detail

Microsoft Excel

Cross-functional coordination

Good written/verbal communication

Confidentiality

Education

Bachelor's or Master's degree in Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, Life Sciences, Healthcare, or related discipline

Tools

EDMS

DMS

eQMS

Job description

Virtue America seeks a detail-oriented Entry-Level Document Control Specialist to support document management and quality documentation within pharma/biotech operations. You will assist with SOPs, records, and controlled documents, ensuring accuracy and regulatory compliance.

Responsibilities include reviewing documents, maintaining DMS/eQMS systems, managing version control, and coordinating with QA, QC, and other departments to ensure proper approvals and archiving.