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Quality Documentation Specialist

Actalent

Posted Friday, April 11, 2025

Posting ID: JP-005202667

Burlington, WI
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Job Title: Quality Documentation Specialist


Job Description

Ensure quality and regulatory documentation and information is maintained throughout the three plants. Maintain and validate all quality and regulatory documentation on a daily basis to ensure everything is in order and compliant such as SDS's, product labels, FSSC information, ISO information, etc.


Responsibilities

  • Maintain and validate all quality and regulatory documentation on a daily basis to ensure compliance.
  • Address quality issues and determine the root cause to provide the correct CAPA.
  • Respond to customer issues/complaints to resolve quality issues and investigate problems.
  • Plan, conduct, and correct any internal and external audits.
  • Maintain the entirety of the quality management system including writing, authoring, and editing SDS's, SOP's, Change Orders, Electronic documentation systems, Regulatory information, etc.
  • Ensure all raw material specifications and customer specifications are documented and verified through production and quality personnel.
  • Provide support as needed for additional laboratory testing.

Essential Skills

  • Strong skillset in Quality Assurance (QA)
  • Experience in documentation management
  • Knowledge of regulatory documentation and information
  • Proficiency with Safety Data Sheets (SDS)
  • Familiarity with product labels and quality documentation
  • Experience with audits (FSSC, SOP's, Internal/External Audits)
  • Ability to interact with R&D, Regulatory, other Quality personnel, operations, suppliers, customers, and external auditors
  • Passion for quality and regulatory work

Additional Skills & Qualifications

  • Safety Data Sheet (SDS)
  • Product Labels
  • FSSC
  • ISO
  • Quality Control
  • Quality Assurance
  • Quality Documentation
  • Quality Audit
  • Food Safety
  • HACCP
  • CAPA
  • NCR
  • RCA
  • Chempax
  • Technical Information
  • Regulatory Affairs
  • Hazard Communication
  • Technical Writer
  • SDS Writer
  • Regulatory Coordinator
  • ISO Practitioner
  • FSSC Practitioner
  • Food Safety Coordinator
  • Documentation Specialist
  • Quality Document Coordinator
  • Registration Specialist

Work Environment

This is a 1st shift, Monday through Friday role with hours from 8:00 a.m. to 4:30 p.m., with potential for overtime if the workload requires it. You will be working with every level of the organization including quality personnel, regulatory, operations/production personnel, customers, and suppliers. A significant portion of your day will be handling QA functions and managing/maintaining/updating the quality systems. You will also fill in for QA personnel when they are out and step in as needed.

Compensation:$58240

Contact Information

Email: abalistreri@actalentservices.com

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
On-Site
audit
batch record review
corrective action plans
document control
documentation quality assurance
iso standards
quality assurance
quality control
root cause analysis
wet chemistry
sds
food testing
batch testing

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