On-Site Document Control & Compliance Specialist (FDA/GMP)

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

Benefits offered by this job

Medical insurance

Dental & Vision insurance

Life insurance

Long-term disability

401(k) retirement plan

Health Savings Account (HSA)

Transportation benefits

PTO

Job summary

Actalent is seeking a meticulous Documentation Specialist to collaborate with R&D, Engineering, Product Management, Manufacturing, Marketing, Sales, and Quality to build and maintain comprehensive analysis and product documentation. The role ensures compliance with FDA/ISO and internal requirements and guides meetings to manage project requirements and deadlines.

You will work on‑site five days a week in Hartland, WI, with hours from 7:30 AM to 4:30 PM, including a one‑hour lunch break.

Qualifications

• Bachelor’s degree in sciences required.
• 1–2 years of QA experience in a regulated FDA environment preferred (medical device or pharma).
• Experience ensuring compliance with FDA/ISO and internal requirements.

Responsibilities

• Document and maintain analysis and product documentation, including batch records and investigation documentation.
• Ensure compliance with FDA, ISO, and internal requirements.
• Facilitate meetings with cross‑functional partners to manage project requirements and deadlines.
• Track and report progress to management.
• Review documentation for completeness and accuracy to meet specifications.
• Demonstrate quality assurance expertise and GMP/FDA regulatory understanding.

Skills

Attention to detail

Documentation control

Root cause analysis

Quality Assurance

Education

Bachelor's degree in Sciences

Job description

Actalent is seeking a meticulous Documentation Specialist to collaborate with R&D, Engineering, Product Management, Manufacturing, Marketing, Sales, and Quality to build and maintain comprehensive analysis and product documentation. The role ensures compliance with FDA/ISO and internal requirements and guides meetings to manage project requirements and deadlines.

You will work on‑site five days a week in Hartland, WI, with hours from 7:30 AM to 4:30 PM, including a one‑hour lunch break.