Document Control Coordinator

Actalent; Town of Hartland (WI); On-site; USD 34,000 - 39,000; Full time

Benefits offered by this job

Medical

Dental & Vision

Hospital 401(k) plan

Life Insurance (Voluntary)

Disability insurance

Health Spending Account (HSA)

Job summary

Actalent is seeking a Documentation Specialist to manage and maintain quality documentation in a fast-paced, on-site setting in Hartland, WI. The role supports batch records, change controls, and investigation documentation to ensure compliance with FDA and ISO requirements.

The candidate will collaborate with cross-functional teams, track project progress, and review files for completeness and accuracy, ensuring reports meet specifications and validations.

Qualifications

• Experience in quality assurance within regulated environments.
• Knowledge of GMP and FDA regulations.
• Strong root-cause analysis and document control skills.

Responsibilities

• Document and maintain analysis and product documentation, including batch records, investigation documentation, change controls, and other quality documentation.
• Ensure compliance with applicable FDA, ISO, and internal requirements.
• Facilitate meetings with cross-functional partners to manage project requirements and deadlines.
• Track and report progress periodically to management.
• Review documentation and analysis for completeness and accuracy, ensuring products and reports meet all specifications.

Skills

Quality assurance expertise

GMP & FDA regulation knowledge

Root cause analysis & document control

Education

Bachelor's degree in Sciences

Job description

Job Title: Documentation SpecialistJob Description

Responsibilities

• Document and maintain analysis and product documentation, including batch records, investigation documentation, change controls, and other quality documentation.
• Ensure compliance with applicable FDA, ISO, and internal requirements.
• Facilitate meetings with cross-functional partners to manage project requirements and deadlines.
• Track and report progress periodically to management.
• Review documentation and analysis for completeness and accuracy, ensuring products and reports meet all specifications.

Essential Skills

• Quality assurance expertise
• Proficiency in GMP and FDA regulations
• Strong skills in root cause analysis and document control

Additional Skills & Qualifications

• Bachelor's degree in Sciences
• 1-2 years of experience in Quality Assurance
• 1-2 years of experience in a regulated FDA environment, preferably in Medical Device or Pharma

Work Environment

This position requires on-site work five days a week, adhering to normal US business hours. You will work between the office and the manufacturing area/warehouse, with hours from 7:30 AM to 4:30 PM, including a one-hour lunch break. While the dress code is not strictly enforced, professional attire is recommended.

Job Type & Location

This is a Contract to Hire position based out of Hartland, WI.

Pay and Benefits

The pay range for this position is $25.00 - $28.00/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
• 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)

Application Deadline

This position is anticipated to close on Oct 30, 2026.

Workplace Type

This is a fully onsite position in Hartland,WI.

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 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 process due to a disability, please email [e-mail] for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.