Document Control Specialist

About the Role

The Document Control Specialist supports the Quality Department by maintaining accurate, current, and controlled quality documentation. This role is responsible for document creation, revision, approval, distribution, and archival and helps ensure documentation is compliant with Good Manufacturing Practices (GMP) and other applicable quality and regulatory requirements.

The position works closely with Quality, Production, Laboratory, Regulatory, and other departments to ensure documents are complete, properly approved, audit-ready, and available to the appropriate teams.

As a Document Control Specialist you will:

Manage controlled quality documentation, including SOPs, specifications, batch records, testing protocols, forms, and records, ensuring effective version control, approval workflows, distribution, and archival.
Maintain the document control system, ensuring only current, approved documents are available and that obsolete versions are appropriately restricted.
Review quality and GMP documentation for accuracy, completeness, compliance, and required approvals, coordinating corrections and updates where necessary.
Partner with Quality, Production, Laboratory, Regulatory, and other functions to maintain accurate documentation, support change controls, CAPAs, employee training records, and periodic document reviews.
Support internal, customer, and regulatory audits by maintaining audit-ready, traceable records and ensuring documentation is readily retrievable.
Monitor and report on document status, review cycles, revisions, and outstanding approvals.
Review batch records and associated manufacturing and quality documentation prior to product release, ensuring records are complete, accurate, compliant, and appropriately approved.
Escalate documentation discrepancies, missing information, or non-compliance issues to the Quality team to ensure GMP requirements are met before product release.

What skills and experience do I need for this role?

Experience with electronic document management systems (EDMS), LIMS, CMS, or similar quality/manufacturing systems.
Familiarity with change control and CAPA processes.
Experience supporting internal, customer, or regulatory audits.
Experience in cosmetics, personal care, pharmaceutical, or contract manufacturing.
Working knowledge of ISO, FDA, or other applicable quality standards.
Experience supporting training related to revised procedures or controlled documentation.
Bilingual English/Spanish is a plus.

Knowledge, Skills & Competencies

Attention to Detail: Thoroughly reviews records and documents for missing information, errors, inconsistencies, and compliance issues.
GMP & Compliance Awareness: Understands the importance of complete, accurate, traceable, and timely documentation in a regulated manufacturing environment.
Organization: Manages document revisions, approvals, records, and deadlines in an organized manner.
Communication: Works effectively with cross-functional teams to resolve documentation issues and obtain required information or approvals.
Systems Proficiency: Comfortable using document control, quality management, CMS, and other electronic systems.
Accountability: Takes ownership of document accuracy, integrity, and timely completion of assigned document control activities.