GMP Documentation Specialist - Katalyst Healthcares & Life Sciences
Round Lake, IL 60073
About the Job
Responsibilities:
- Batch Documentation Review: Review manufacturing batch records to ensure compliance with specifications and submission schedules.
- Compliance Assurance: Confirm that batch documentation adheres to GDP (Good Documentation Practice) standards.
- Documentation Management: Verify the presence of all required documents before submitting batch folders to Quality. Maintain organized and retrievable file systems.
- Work Orders: Initiate and close GME (Good Manufacturing Environment) work orders; use Maximo system for preventative maintenance work orders.
- Non-Conformance: Author Non-Conformance Records (NCRs) and manage exceptions investigations.
- Documentation Changes: Author and manage TCU (Technical Change Unit) documentation changes, including revisions, periodic reviews, and GAP assessments.
- System Usage: Utilize SYSTECH for batch count approvals and Maximo for maintenance work orders.
- Batch Folder Initiation: Perform necessary data entry to initiate batch folders.
- Support GME Cycle Counting: Assist with cycle counting as required.
- Administrative Duties: Perform other administrative tasks as assigned.
- Proficiency in MS Office Suite.
- Knowledge of documentation systems and familiarity with batch/systems documentation preferred.
- Strong attention to detail and organizational skills.
- Ability to prioritize tasks and work with minimal supervision.
- Effective verbal and written communication skills.
- Capability to identify areas for continuous improvement.
- Ability to lift up to 30 pounds.
- Must not be allergic to Penicillin or Cephalosporin drugs.
- Flexibility: Willingness to adjust work hours and work overtime based on business needs.
- Education: Associate's degree or equivalent experience.
- Experience: 3+ years of experience in a manufacturing environment and/or quality documentation.
Source : Katalyst Healthcares & Life Sciences