• Coordinates the revision process of Standard Operating Procedures (SOPs), forms and other controlled documents
• Assists in organizing QA records and scanning, archiving, maintain historical files for SOPs, and Forms
• Creates and maintain document templates
• Enters, updates, and edits-controlled documents and coordinate requirements for new documents with internal customers
• Serves as a local system administrator for the Quality Management System
• Assign numbers to and control the issuance and use logbooks and laboratory notebook
• Oversee the issuance of batch/lot numbers and batch production records in support
• Finalize and publish working documents like SOPs, batch records etc. for use by Production and test methods and validation protocols etc. for use by Analytical.
• Control distribution and monitor workflow of controlled documents, maintain document database on Revised and distributed SOPs.
• Issue controlled documents for training, testing or batch production purposes.
• Compile literature review and patent searches
• Assist in writing SOPs, reports and protocols
• Assign training workflows for new or revised quality system procedures and for new employees
• Maintain training records files for all employees
• Coordinate with area managers the creation and maintenance of training curriculums • Other tasks assigned by superior
• Bachelor's degree with at least 2 years of experience in the pharmaceutical biotech industry
• Document control experience and Document Management Software implementation experience
• Knowledge of document management processes
• Proficient computer skills (Microsoft Office Suite, Outlook, Adobe)
• Ability to multitask, highly organized and detail-oriented
• Function effectively both independently and as part of a team
• Must exhibit a positive/professional attitude, ability to work independently and with team
• Strong attention to detail, accuracy and organization skills required
Independent Recruiting is looking for candidates in all industries.