What are the responsibilities and job description for the DOCUMENT CONTROL SPECIALIST I position at LGM Pharma, LLC?
Job Description
Job Description
RESPONSIBILITIES :
- Issuance and reconciliation of cGMP records, including but not limited to Master Batch Records, Packaging Reports, Product Specifications, Raw Material / Packaging Component Lab Reports, requested forms, and notebooks.
- Creation, issuance and reconciliation of logbooks.
- Execute and maintain physical document backup, archival, retrieval and destruction.
- Maintains electronic and / or paper-based document repositories, ensuring proper organization and accessibility / retrievability.
- Maintain SOP binders throughout the facility.
- Order supplies for the Quality Assurance Department.
- Issue release stickers for raw materials, packaging components, and labeling materials for production use.
- Perform material transfers in the ERP system.
- Generate monthly Raw Material Re-evaluation Report.
- Performs document formatting, editing, and quality checks to ensure accuracy and consistency on Master Control. Confer with document originators to resolve discrepancies and compile required changes to documents.
- Participate in routine Key Performance Indicator (KPI) reporting.
- Maintain tracking and create reports related to Document Control activities.
- Supports audits and inspections by providing requested documentation.
- Other related duties as required.
QUALIFICATIONS :
