Job Title: Batch Record SpecialistJob Description We are seeking a Batch Record Specialist who understands Good Documentation Practices (GDP) and the importance of reviewing batch records in compliance with FDA requirements. The role involves teaching how to review documents, verifying details using basic math, and ensuring that the verifier is different from the person who performed the initial task. Responsibilities + Review and verify 100 batch records per week. + Ensure compliance with GDP and FDA requirements. + Teach and guide others on document review processes. + Perform root cause analysis when necessary. + Maintain quality assurance standards during batch record reviews. Essential Skills + Strong understanding of Good Documentation Practices (GDP). + Knowledge of FDA regulations and requirements. + Ability to perform basic mathematical calculations using a calculator. + Experience in quality assurance. + Proficiency in batch record review and documentation processes. Additional Skills & Qualifications + Bachelor's Degree in Sciences or 2-3 years of experience in Quality Assurance. + 2 years of experience in a regulated FDA environment. + 6 months of experience with batch records review. Work Environment The role requires working between the office and the manufacturing area/warehouse. The standard working hours are from 7:30am to 4:30pm, with a one-hour lunch break. While a dress code is not required, flexibility in attire is appreciated if open to it. Pay and Benefits The pay range for this position is $27.00 - $27.00/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 Hartland,WI. Application Deadline This position is anticipated to close on Jun 27, 2025. 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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.