Document Coordinator

Document Coordinator

Job Description

The Document Coordinator processes, organizes, and maintains a wide range of site documentation within a cGMP-regulated environment. This role ensures that all documents are accurately controlled, cataloged, and readily accessible to support production, regulatory compliance, and audit activities. The position requires strong attention to detail, proficiency with computer-based systems, and the ability to work in a facility that produces life-changing diagnostic drug products.

Responsibilities

• Process various site documents using computer-based systems, including Standard Operating Procedures (SOPs), Standard Certification Methods (SCMs), Standard Testing Methods (STMs), Specifications, and Batch Production Records.
• Catalog, scan, maintain, archive, file, and retrieve site documents and records such as SOPs, Batch Records, Datasheets, Logbooks, Notebooks, Regulatory Documents, and Validation Protocols.
• Update indices and tracking tools in applications such as Excel, Access, and other database or spreadsheet systems to ensure accurate and current document information.
• Prepare logbooks and issue logbooks and notebooks for use across the site, ensuring proper documentation practices are followed.
• Support Regulatory Affairs for the United States and Canada by supplying current and historical documents and assisting in gathering information for audit events.
• Ensure daily tasks are completed in a timely manner with strict attention to detail and in accordance with applicable SOPs and cGMP requirements.
• Assist in training new employees and temporary or contract workers on job-specific Document Control processes and procedures.
• Assist with audits by preparing materials, setting up and breaking down audit rooms, and retrieving requested documents promptly and accurately.
• Maintain organized document control systems to support efficient retrieval and compliance with regulatory and internal requirements.
• Collaborate with cross-functional teams to ensure documentation needs are met and document control practices are consistently applied.

Essential Skills

• Five (5) years of documentation experience in a cGMP facility or in the medical transcription field, or equivalent experience.
• High School Diploma or equivalent is required.
• Experience with computer data entry in a professional environment.
• Proficiency with Microsoft Office applications, including Word, Excel, Access, Visio, Outlook, and PowerPoint.
• Demonstrated knowledge of cGMP requirements and their application to documentation practices.
• Experience working with document control processes in regulated environments.
• Ability to work accurately with detailed information and maintain strict attention to detail.
• Capability to support FDA and other regulatory documentation requirements, including batch records and SOPs.

Additional Skills & Qualifications

• Associate’s degree preferred.
• Office administration experience will be considered as relevant background.
• Familiarity with FDA-regulated environments and documentation expectations.
• Experience handling batch records, SOPs, and other controlled documents.
• Strong organizational and time management skills to handle multiple document-related tasks.
• Ability to communicate clearly and professionally with colleagues across different departments.
• Willingness to support training efforts for new and temporary staff on document control processes.

Work Environment

This role is based in a production plant that manufactures diagnostic drug products, including radioactive materials. Employees participate in safety programs designed to minimize potential and actual exposure levels, and must consistently follow all safety procedures and protocols. The position may require lifting up to 50 lbs., as well as walking, bending, stooping, kneeling, crouching, pushing, pulling, reaching, balancing, and climbing stairs and ladders, with or without accommodation. Work hours may extend beyond regular business hours, and flexibility is necessary to support operational and audit needs. The environment emphasizes growth opportunities, long-term career potential, and contributing to the production of life-changing diagnostic products.

This is a Contract position based out of Maryland Heights, MO.

The pay range for this position is $20.00 - $24.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Maryland Heights,MO.

This position is anticipated to close on Sep 3, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.