David Morell Email & Phone Number

South San Francisco, California, United States

• Provided consistent support to Facilities and Engineering during Quality Management System transition, including comprehensive review of new work orders for potential Unplanned Events and revisions to the relevant.
• Facilitated the transition of intake and triage responsibilities of new discrepant events to the frontline quality support team
• Developed work instructions for the triage and intake of new Unplanned Events
• Continually improve the discrepancy management process, including the creation of visual management to explain process flows, numerous job aids that are used throughout the assessment process, and a tool to track the.
• Functioned as mentor and first point of contact for MQA Associates on rotation into the Quality Reviewer group, providing support and coaching, especially with soft skills and conflict resolution
• Train, coach, and develop a variety Discrepancy Owner groups, including those from operations, automation, maintenance, and process engineering

South San Francisco, California, United States

• Function as the Quality representative for the Drug Product Periodic Process Monitoring Review Board, working with QC, DPPE, and others to review process monitoring data for potential capability shifts and determine.
• Support the Risk Assessment process by providing quality approvals of Drug Product Risk Assessments
• Provide quality oversight of the Discrepancy Management System, working with cross-functional teams to leverage a range of subject matter experts while ensuring overall compliance with industry standardsContinued in.

South San Francisco, California, United States

• Performed periodic reviews of documentation errors and create work instructions for manufacturing and quality personnel to provide visibility and guidance to ensure mistakes are not repeated
• Provided input during document and procedure revisions to simplify and clarify complicated processes
• Served on cross functional production efficiency teams to improve and streamline the manufacturing process by investigating discrepant events and assessing and addressing root causes
• Qualified as an RCA facilitator, and trained in Lean Six Sigma methodology
• Compiled a library of useful reference materials including process flows, contact lists, work instructions, and transaction lists
• Managed and reviewed discrepant events to determine cause, corrective action, and potential impact

South San Francisco, California, United States

See MQA Associate II section

South San Francisco, California, United States

• Functioned as shift trainer and back up lead, managing technician qualifications and schedules
• Served as 5S representative and member of the Continuous Process Improvement Team
• Implemented an adjustable height set up cart for the GPMF clean room in response to a CAPA/STARI
• Designed and implement a storage unit to efficiently organize the processing spaces
• Trained new employees through GPMF Onboarding and provided continuous on the job training
• Collaborated with MSAT, Mechanics, and MQA to troubleshoot issues with the machinery

Woodland, California, United States

• Led a project to measure surplus seed to decrease the amount of wasted product
• Performed timely, routine Real Time PCR and ELISA assays on commercial seed samples
• Maintained a sufficient chemical and equipment supply as well as lab cleanliness
• Tracked samples and tests using SAP and LIMS programs
• Assisted in the implementation of alternate procedures to decrease waste streams
• Assisted in the mechanization of routine processes to remove 2.5 million repetitive motions per year