Document Control Specialist

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• Coordinate distribution of approved documents and withdraw outdated versions.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

We are seeking a detail-oriented and organized Entry-Level Document Control Specialist to support document management and quality documentation activities within the pharmaceutical, biotechnology, and life sciences industry. The candidate will assist in creating, reviewing, organizing, tracking, maintaining, and archiving controlled documents to ensure accuracy, consistency, and compliance with established company procedures and regulatory requirements.

This role involves managing quality-related documents, standard operating procedures (SOPs), work instructions, validation records, manufacturing documents, laboratory records, and other essential business documents. The selected candidate will work closely with Quality Assurance (QA), Quality Control (QC), Manufacturing, Engineering, Regulatory Affairs, and other departments to maintain an effective document control system.

Key Responsibilities

• Document Management: Assist in receiving, reviewing, organizing, maintaining, and tracking controlled documents, including SOPs, policies, work instructions, forms, protocols, and reports.
• Document Review and Formatting: Check documents for completeness, formatting accuracy, correct version details, approval information, and compliance with established documentation standards.
• Document Control Systems: Maintain and update electronic and physical document records using document management systems (DMS) and electronic quality management systems (eQMS).
• Version Control: Track document revisions, maintain revision histories, and ensure that the latest approved versions are available to authorized employees.
• SOP Management: Support the preparation, routing, review, approval, distribution, revision, and periodic review of Standard Operating Procedures (SOPs).
• Document Distribution: Coordinate the distribution of approved documents to relevant departments and ensure that outdated or superseded versions are properly withdrawn from use.
• Quality Documentation: Assist in maintaining quality-related records, including deviations, CAPA documentation, change controls, audit records, validation documents, and training records.
• Regulatory Compliance Support: Follow Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and applicable regulatory guidelines when handling controlled documents.
• Electronic Records Management: Maintain electronic files, document metadata, approval records, access permissions, and audit trails in accordance with company procedures.
• Archiving and Record Retention: Support the filing, indexing, storage, retrieval, and archiving of documents while following established record retention policies.
• Audit and Inspection Support: Retrieve and organize required documentation for internal audits, external audits, and regulatory inspections. Ensure records are readily accessible and properly maintained.
• Training Documentation: Assist in maintaining employee training records and coordinating documentation related to SOP updates and required training activities.
• Cross-Functional Coordination: Work with QA, QC, Manufacturing, Engineering, Regulatory Affairs, and other teams to collect documents, follow up on pending approvals, and resolve documentation-related issues.
• Document Tracking and Reporting: Maintain document logs, revision trackers, approval status reports, and periodic review schedules using Microsoft Excel or other tracking tools.
• Continuous Improvement: Identify opportunities to improve document filing, tracking, retrieval, and control processes to support efficient quality system operations.

Required Skills

• Bachelor's or Master's degree in Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, Life Sciences, Healthcare, or a related discipline.
• Basic understanding of pharmaceutical and biotechnology industry operations.
• Knowledge of document management, record keeping, and controlled documentation practices.
• Basic understanding of Standard Operating Procedures (SOPs), work instructions, forms, and quality records.
• Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Basic awareness of quality management systems and regulatory documentation requirements.
• Proficiency in Microsoft Office applications, particularly Word and Excel.
• Familiarity with electronic document management systems (EDMS), document management systems (DMS), or electronic quality management systems (eQMS) is an advantage.
• Strong organizational and record-management skills.
• Excellent attention to detail and accuracy.
• Ability to maintain document confidentiality and follow established procedures.
• Good written and verbal communication skills.
• Ability to coordinate with multiple departments and follow up on documentation requirements.
• Basic analytical and problem-solving skills.
• Willingness to learn document control procedures, quality systems, and pharmaceutical regulatory requirements.