Data Entry Operator III

The Data Entry Specialist's primary responsibility is transcribing data into Global Data Mart (GDM). The DE Specialist will support the MSAT Team, the Process Analytics Team, the Process Validation Team and Investigation teams thereby supporting the critical successive steps essential to ***'s local as well global manufacturing operations. The Data Entry Specialist focus is to locate, collect, manually enter and verify batch record data. The Data Entry Specialist must ensure data integrity as well as timely data availability to internal and external data consumers. A Data Entry Specialist will work with the Manufacturing Teams to understand the process, its flow and unique steps such that he/she can manually transcribe and verify the data which characterizes and defines the process itself in accordance with cGMP


• 80% - Enter and verify large amounts of information accurately and consistently from process Batch Records
o Manage and Track workload, ensure all necessary process data is located entered
o Develop and utilize existing tools to examine, manage and track workload
o Provide timely and accurate entry of process data in support of daily process monitoring and associated activities
o Manage special requests for data collection, completion and/or verification
o Help to Ensure all data entry system procedures and guidelines are accurate and current
o Ensure 100% accuracy of all information entered, right first time


• 5% - Understand Basic Processing and Analytics
o Will develop and understanding of the relationship between data collection and process monitoring
o Will develop understanding of basic manufacturing process technologies, terminologies and analysis tools
o Will develop an understanding of the Statistica Enterprise Architecture such that this knowledge can be applied to creation and maintenance of data collection systems


• 5% - Interaction and user support for data consumption and analytics
o Routinely interact with data consumers, help to create necessary efficiencies
o Work to build user confidence in the system
o Observe how *** users interact with GDM, understand their needs provide support as required
o Resolve data entry related analytics problems with users


• 10% - Training:
o Follows all training and policy guidelines established for the facility as well as all cGMP requirements. Ensures employee training profile is up to date at all times by regular monitoring of training lists (e.g. ComplianceWire, SAP Learning Portal) and completing all training in a timely fashion.


• Perform other duties as assigned.


High School Diploma or Equivalent
0-3 years of biotech industry as well as relevant data collection systems exposure preferred
Solid computer skills including Microsoft Office a must
Detail oriented, Self-motivated, able to work independently.


On-Site 100% - days may vary - could work out to be Tuesday through Saturday or Sunday through Thursday.