Responsibilities • 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 Requirements • 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