Documentation Specialist

Summary

Position reports to Manufacturing functional areas and provides the Manufacturing documentation review. Responsibilities include reviewing batch records and other GMP documents to ensure compliance with cGMP, Company Policies, and local SOPs.

• Support manufacturing batch documentation review.
• Ensure batch records meet specifications and are submitted to Quality per release schedule.
• Assure batch documentation complies with GDP standards.
• Determine acceptability using specifications and SOPs.
• Ensure presence of all required documentation before submission of batch folder to Quality.
• Maintain files to keep documents readily available and retrievable.
• Initiate and close GME work orders.
• Author Non-Conformance Records (NCRs) and Exceptions Investigations.
• Author TCU documentation changes, including revisions, periodic reviews, and GAP assessments.
• Use Maximo system to print department preventive maintenance work orders; assign and bring to completion as necessary.
• Use SYSTECH to review and approve batch counts.
• Initiate batch folders by performing necessary data entry.
• Support GME cycle counting as needed.
• Perform other administrative duties as assigned.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Strong computer skills in MS Office Suite.
• Knowledge of documentation systems and familiarity with batch/systems documentation.
• Strong attention to detail.
• Work independently with minimal supervision in a dynamic environment while following written procedures; organized and able to prioritize tasks.
• Ability to communicate efficiently verbally and in writing with all levels of the organization.
• Identify areas for continuous improvement.
• Willingness to adjust work hours and work overtime based on business needs.
• Must be able to lift 30 pounds.
• Must not be allergic to Penicillin or Cephalosporin drugs.

• Associate's degree or 3+ years of experience in a manufacturing environment and/or quality documentation.