GMP & FDA Document Control Specialist

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

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.