Document Control Associate

Job Title: Document Control Associate

Job Description

As a Document Control Associate, you will play a crucial role in managing and organizing documentation processes. Your tasks will include change control logging, organizing and tracking documentation flow, ensuring completion of training and annual SOPs, and supporting the creation and approval of master documents.

Key Responsibilities

Supplier

Quality Oversight

• Establish and maintain a Supplier Quality Management Program for CMOs, CTLs, 3PLs, raw material suppliers, and packaging component suppliers.

• Develop and maintain critical SOPs for supplier management, including supplier qualification, auditing, issue resolution, and change control.

• Monitor supplier performance through quality metrics, supplier evaluations, and risk assessments.

• Develop and maintain a supplier qualification and requalification process to ensure ongoing compliance.

Audits & Compliance

• Plan, coordinate, and execute supplier audits (on-site, virtual, and desktop reviews) to assess compliance with cGMP, ICH, and regulatory requirements.

• Lead audit activities, including scheduling, performing, and documenting audit findings in supplier audit reports.

• Collaborate with suppliers to address audit findings and ensure timely implementation of corrective and preventive actions (CAPAs).

Quality Agreements

• Spearhead the development, negotiation, and maintenance of Quality Agreements with CMOs, CTLs, 3PLs, and material suppliers.

• Ensure Quality Agreements align with regulatory requirements and internal quality expectations.

• Work with Legal, Regulatory, and Supply Chain teams to maintain up-to-date agreements.

Supplier Non-Conformance & Change Control

• Manage supplier-related deviations, non-conformances, and CAPAs.

• Ensure effective root cause analysis (RCA) and resolution of supplier issues.

• Review and assess supplier-initiated change controls for impact on product quality and compliance.

Regulatory & Quality Compliance

• Ensure supplier quality practices comply with FDA, ICH Q7, USP, and ISO 9001 (as applicable).

• Maintain awareness of industry best practices and evolving regulatory requirements.

• Support regulatory inspections and internal audits by providing supplier quality documentation as needed.

Development of Critical SOPs

• Author, review, and maintain essential SOPs governing supplier qualification, audits, risk management, supplier monitoring, and supplier-related change control.

• Ensure SOPs align with current regulatory expectations and industry best practices.

• Train internal stakeholders on supplier management procedures to ensure consistent application.

Essential Skills

• Proficiency in document control and quality assurance processes.

• Strong data entry skills.

• Proficiency in Microsoft Office, including Excel.

• Experience in batch record review and change control.

• Ability to revise and update SOPs.

• Strong writing and communication skills.

• Ability to build and maintain customer relationships.

• Critical thinking skills.

Additional Skills & Qualifications

• High school diploma with relevant experience or a Bachelor of Science degree.

Work Environment

You will work within the QA group, primarily during the 1st shift with flexible start times for 8-hour days. The role is based in an office environment.

Job Type & Location

This is a Contract to Hire position based out of Mount Prospect, IL.

Pay and Benefits

The pay range for this position is $18.00 - $20.00/hr.

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)

Workplace Type

This is a fully onsite position in Mount Prospect,IL.

Application Deadline

This position is anticipated to close on Jan 24, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.