Job Title: Documentation SpecialistJob Description We are seeking a meticulous Documentation Specialist to work closely with cross-functional teams, including R&D, Engineering, Product Management, Manufacturing, Marketing, Sales, and Quality, to build and maintain comprehensive analysis and product documentation. This role involves ensuring that documentation is compliant with applicable FDA, ISO, and internal requirements, and facilitating meetings to manage project requirements and deadlines. 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, 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) Job Type & Location This is a Contract to Hire position based out of Hartland, WI. 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 [email protected] 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.