Scheena Hinzman Email & Phone Number

Chapel Hill, NC, US

• Perform document control activities within Documentum EDMS such as formatting and editing documents that support GMP operations.
• Revise Documents for the department
• Issue Batch Records and Logbooks.
• Responsible for routing master batch records for revision
• Responsible for sending collecting documents and information to send to Regulatory.
• Responsible for updating multiple databases for Quality department.

• Perform document control activities within Livelink EDMS such as verification of form Completion trouble shooting workflows and report generation.
• Format and edit documents, including Standard Operating procedures, Specifications, Controlled Forms, and Policies that support GMP operations.
• Issue logbooks and assay forms.
• Assist in closing department deviations and CAPAs

• Perform document control activities within Electronic Document Management System (EDMS) such as uploading drawings, documents, and specifications into the system, and updating each new revision.
• Receive, stamp, log, and file drawings and documents, including piping isometrics,specifications and drawings for all disciplines (Architectural, Piping, Fire Protection, Plumbing, Electrical, Loops, Control System.
• Data entry into document management database and/or excel spreadsheet.
• Issue project transmittals and keep transmittal record database.
• Audit master list on a regular basis to maintain most current revision.
• Maintain current construction documents on master sticks at all times for construction reference.

• Responsible for all aspects of managing analytical data generated by the Assay Support Group prior to reporting to customers. Performs analysis of data based on Project, phase of development, knowledge of test methods.
• Responsible for analyzing data for consistency with expected outcomes of studiesperformed in R&D or Technical Operations and making recommendations on the release of results to customers.
• Responsible for reviewing and verifying analytical test records to ensure accuracyAnd completeness.
• Coordinated sample submissions with customers, assuring correct compilation oflot assessments and implementing systems to improve current practices for GMP compliant archiving and retrieval of test results.
• Implement computer-based electronic data management/capture technology in the Laboratory for use in storage/retrieval of scientific data.
• Logged in samples from internal customers using Laboratory Information Management System for various Analytical testing.