Job Description
This role requires a comprehensive understanding of Good Documentation Practices (GDP) and the importance of reviewing batch records. The specialist will be responsible for teaching how to review documents and comprehend FDA requirements. The position involves verifying details using basic mathematical calculations, with equations provided in the batch records. Knowledge of FDA facility document review processes is beneficial, and it is crucial to ensure that the verifier is not the same individual who completed the batch record.
ResponsibilitiesReview approximately 100 batch records per week, ensuring accuracy and compliance.Teach and implement Good Documentation Practices (GDP).Verify batch record details using basic mathematical calculations.Ensure compliance with FDA requirements during document reviews.Conduct root cause analysis to identify and rectify discrepancies.Essential SkillsExperience in batch record review.Knowledge of Quality Assurance practices.Understanding of GMP and FDA regulations.Ability to conduct root cause analysis.Additional Skills & QualificationsBachelor'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 record review.Work Environment
The specialist will work between the office and the manufacturing area/warehouse. Work hours are from 7:30 am to 4:30 pm, with a one-hour lunch break. Casual attire is acceptable, though professional attire is preferred for office hours.
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 for other accommodation options.