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Documentation Specialist

2 months ago

Round Lake, Illinois, United States Equiliem Full time
Job Summary

This position plays a critical role in ensuring the accuracy and compliance of manufacturing documentation. As a Documentation Specialist, you will be responsible for reviewing and verifying batch records and other GMP documents to ensure they meet company policies and local SOPs.

Key Responsibilities
  • Batch Documentation Review: Review batch records and other GMP documents to ensure compliance with cGMP, company policies, and local SOPs.
  • Documentation Maintenance: Ensure batch records meet specifications and are submitted to Quality per release schedule.
  • Documentation Compliance: Ensure batch documentation complies with GDP standards.
  • Documentation Verification: Determine acceptability by using specifications and standard operating procedures.
  • Documentation Management: Ensure presence of all required documentation prior to submission of batch folder to Quality.
  • File Maintenance: Maintain files such that documents are readily available and easily retrievable.
  • Administrative Support: Initiate and close GME work orders, author Non-Conformance Records (NCRs) and Exceptions Investigations, and use Maximo system to print department preventative maintenance work orders.
  • Quality Assurance: Use SYSTECH to review and approve counts for batches, initiate batch folders by performing necessary data entry, and support GME cycle counting as needed.
Requirements
  • Education and Experience: Associate's degree or 3+ years of experience in a manufacturing environment and/or quality documentation.
  • Skills and Abilities: Strong computer skills in MS Office Suite, knowledge of documentation systems, and familiarity with batch/systems documentation preferred. Strong attention to detail, ability to work with minimal supervision, and ability to communicate efficiently verbally and in writing with all levels of the organization.
  • Physical Demands: Ability to lift 30 pounds and not be allergic to Penicillin or Cephalosporin drugs.