GMP Document Control Specialist

The Hut Group; New Jersey; On-site; USD 60,000 - 70,000; Full time

Job summary

The Hut Group is seeking a Document Control Specialist to support the Quality Department by maintaining accurate, current, and controlled quality documentation at our Edison, NJ site. You will create, revise, approve, distribute, and archive documents to ensure GMP and regulatory compliance.

You will collaborate with Quality, Production, Laboratory, and Regulatory teams to maintain audit-ready records, and support change controls, CAPAs, and training documentation across the organization.

Qualifications

• 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.
• 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.

Responsibilities

• 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.

Skills

EDMS/LIMS/CMS systems

Change control

CAPA processes

Audits (internal/customer/regulatory)

ISO/FDA quality standards

Training documentation

Bilingual English/Spanish (a plus)

Attention to detail

GMP & compliance awareness

Organization

Communication

Systems proficiency

Accountability

Job description

The Hut Group is seeking a Document Control Specialist to support the Quality Department by maintaining accurate, current, and controlled quality documentation at our Edison, NJ site. You will create, revise, approve, distribute, and archive documents to ensure GMP and regulatory compliance.

You will collaborate with Quality, Production, Laboratory, and Regulatory teams to maintain audit-ready records, and support change controls, CAPAs, and training documentation across the organization.