Minimum Education : Highschool Diploma or Equivalent; associate or bachelor's degree optional
Job Description :
The Plant Document Specialist is responsible for managing Document Control programs that ensure all documents related to the product quality meet the requirements this includes, maintaining, controlling, and auditing documentation for compliance, and reviewing assigned production documentation.
Responsibilities : Maintain, control and audit site documentation in electronic and paper systems to ensure compliance with cGMP.
These include :
Standard Operating Procedures & Associated Documents.
Manufacturing Batch Production Records & Associated Documents.
GMP Training Records.
Create records as per site procedures and provide to Operations for manufacturing activities
Create and maintain Standard Operating Procedures (including but not limited to procedures, forms, maintenance work, logbooks, etc.) for the cGMP compliance programs
Manage site's electronic and paper document control systems designed to achieve cGMP compliance and provide training on its use
Manage filing system for current and archived documents required for cGMP compliance, including management of documents on site and those sent to an off-site 3rd party storage location
Manage libraries of SOPs (Standard Operating Procedures), Formulas, Manufacturing SOPs, Lab SPIs, and general SOPs to ensure accuracy and reliability
Manage SOP (Standard Operating Procedures) periodic review program and track / report KPI (Key Performance Indicators)
Audit / review all assigned documentation required to support the business, including logbooks, preventive maintenance forms, etc.
Required Competencies
One to three years of industrial experience in FDA regulated consumer products, pharmaceutical or Food industries. This experience should include working in a quality system environment with exposure to governmental audits and assessments.
Self-driven, detail-oriented, and able to work independently on regularly scheduled (daily, weekly, etc.) tasks.
Possess excellent ability to understand, read, speak, and write in English.
Excellent interpersonal and communication skills. Able to communicate information clearly, simply and in a timely manner.
Strong multitasking skills and excellent time management skills.
Working knowledge of Google Docs, Sheets, Slides, as well as Microsoft Word, Excel, and PowerPoint. SAP experience is a plus
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