What are the responsibilities and job description for the DOCUMENT CONTROL CLERK position at LGM Pharma, LLC?
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:
• Associates Degree (A.A.) or the equivalent of three (3) years’ experience in Document Control, preferably in a pharmaceutical or equivalent industry.
• Experience with cGMP environment, regulations, terminology, and workflow, preferred.
• Ability to read and interpret SOPs, GMPs, and government regulations.
• Ability to multi-task and prioritize tasks as needed.
• Ability to work independently and as part of a team.
• Proficient in Microsoft Word, Excel, and PowerPoint.
Salary : $18 - $24
