Job Description
Documentation Control Assistant
Location: Raleigh, NC
Schedule: Fully Onsite | Monday–Friday | Normal Business Hours
Salary: $50,000–$65,000
Position Summary
The Documentation Control Assistant provides document control support to ensure GMP-controlled documents are accurate, compliant, and maintained throughout the document lifecycle. This role works closely with cross-functional teams to support document preparation, revisions, approvals, records management, and archival activities while ensuring compliance with GMP, Good Documentation Practices (GDP), and company quality standards.
Key Responsibilities
- Coordinate the preparation, review, revision, and maintenance of GMP-controlled documents.
- Format, edit, proofread, and manage controlled documents for accuracy and compliance.
- Support document routing, approvals, issuance, distribution, and version control within electronic document management systems (EDMS).
- Maintain document control records and ensure documents are current, properly archived, and readily accessible.
- Track document revisions, change requests, and documentation deadlines.
- Support records management, document retrieval, and archival activities.
- Respond to documentation inquiries and resolve document-related issues.
- Collaborate with cross-functional teams to ensure documentation aligns with company procedures and regulatory requirements.
- Generate document control reports, metrics, and tracking logs.
- Assist with audit and inspection readiness by organizing and retrieving documentation.
- Support continuous improvement initiatives related to document control and records management.
- Perform additional duties as assigned.
QualificationsRequired
- 2–4 years of experience in document control, records management, quality systems, or administrative support within a GMP-regulated environment.
- Experience creating, formatting, reviewing, and maintaining controlled documents such as SOPs, work instructions, forms, records, and training documents.
- Working knowledge of GMP regulations, Good Documentation Practices (GDP), and document control principles.
- Strong organizational skills with the ability to manage multiple priorities while maintaining a high level of accuracy.
- Proficiency with Microsoft Office (Word, Excel, Outlook) and electronic document management systems (EDMS).
- Excellent attention to detail and commitment to documentation accuracy.
Preferred
- Associate's or Bachelor's degree in Business Administration, Life Sciences, Quality, Technical Writing, or a related field.
- Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
- Familiarity with EDMS, Learning Management Systems (LMS), and Quality Management Systems (QMS).
- Experience supporting audits, inspections, records management, and document archival.
- Strong written and verbal communication skills with the ability to work effectively across departments.
- Experience identifying and implementing process improvements.
Work Environment
- Fully onsite position based in Raleigh, NC.
- Standard Monday–Friday business hours.
- Primarily office-based with occasional work in manufacturing, laboratory, warehouse, or archival areas.
- Frequent computer use and document review.
- Must be able to occasionally lift up to 25 pounds and comply with applicable GMP and safety requirements.
- No supervisory responsibilities.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.
Why Kelly Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit thei