Documentation Control Assistant

Guerbet; Raleigh (NC); On-site; USD 48,000 - 64,000; Full time

Job summary

Guerbet is seeking a Documentation Assistant to support GMP documentation throughout the lifecycle, ensuring accuracy, compliance, and alignment with regulatory requirements. You will format, edit, proofread, route, issue, and archive GMP‑controlled documents, while maintaining records and assisting with inquiries across cross‑functional teams.

This role contributes to continuous improvement of the document control process in a regulated medical environment, supporting audits and timely

Qualifications

• 2–4 years of experience supporting document control in a GMP-regulated environment.

Responsibilities

• Coordinate the preparation, review, revision, and maintenance of GMP-controlled documents throughout the document lifecycle.

Skills

Document control

Microsoft Office

EDMS

Attention to detail

Organizational skills

Education

Associate’s or Bachelor's degree

Tools

EDMS

LMS

QMS

Job description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

The Documentation Assistant will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The Document Assistant provides comprehensive document control support by coordinating the preparation, review, revision, and maintenance of GMP-controlled documents throughout the document lifecycle. Working closely with cross-functional teams, this role ensures documentation is accurate, compliant, and aligned with applicable regulatory requirements, company standards, and operational procedures. Responsibilities include document formatting, change coordination, archival support, document tracking, records management, and assisting with documentation inquiries. The Document Assistant independently manages routine documentation activities and contributes to the continuous improvement of document control processes within a regulated environment.

YOUR ROLE

• Coordinate the preparation, review, revision, and maintenance of GMP-controlled documents throughout the document lifecycle.
• Format, edit, and proofread documents to ensure accuracy, consistency, and compliance with regulatory requirements and company standards.
• Assist with document routing, approval workflows, issuance, and distribution within document management systems.
• Maintain document control records and ensure documents are current, properly archived, and readily accessible.
• Support records management and archival activities, including on-site and off-site storage and retrieval.
• Track document revisions and change requests to ensure proper version control and compliance.
• Respond to documentation inquiries and assist in resolving document-related issues with internal and external stakeholders.
• Collaborate with cross-functional teams to ensure documentation aligns with applicable procedures, policies, and regulatory requirements.
• Monitor documentation activities and deadlines to support timely completion of assignments.
• Contribute to continuous improvement initiatives related to document control and records management processes.
• Maintain confidentiality and integrity of controlled documents and records.
• Performs other duties as assigned by management

YOUR BACKGROUND

Required Qualifications

• 2–4 years of experience supporting document control, records management, quality systems, or administrative functions in a GMP-regulated environment.
• Experience creating, formatting, reviewing, and maintaining controlled documentation such as SOPs, work instructions, forms, records, and training documents.
• Working knowledge of GMP regulations, Good Documentation Practices (GDP), and document control principles within a regulated environment.
• Ability to manage multiple document-related tasks, priorities, and deadlines while maintaining a high level of accuracy and compliance.
• Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and electronic document management systems (EDMS).
• Strong attention to detail, organizational skills, and commitment to document accuracy and consistency.

Preferred Qualifications

• Associate's or Bachelor's degree in Business Administration, Life Sciences, Quality, Technical Writing, or a related field.
• Experience working in a GMP-regulated pharmaceutical, biotechnology, medical device, or manufacturing environment.
• Familiarity with electronic document management systems (EDMS), learning management systems (LMS), and quality management systems (QMS).
• Knowledge of Good Documentation Practices (GDP) and document lifecycle management processes.
• Experience supporting audits, inspections, records management, or document archival activities.
• Strong written and verbal communication skills with the ability to collaborate effectively across departments.
• Ability to identify process improvement opportunities and contribute to documentation and records management initiatives.

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number+19843443717