Documentation Control Assistant

Job Description

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. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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 their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.