Quality Assurance
Resume:
RATNA P. LEONARD
Woodland Hills, CA 91367
Cell Phone: 818-***-****
Email: *****.*******@*****.***
Education
Bachelor of Science in Chemical Engineering (Biomedical Option)
University of California Los Angeles (Spring 2005 Graduate)
Training
cGMP & cGDP
Non-Conformance Management using Trackwise 8, Calibration Manager, and JDE systems
Fully Automated Plasma Fractionation process including Precipitation, Filtration, and Centrifugation using DeltaV Batch Processing Control System
Albumin Processing including Ultrafiltration and Sterile Filtration
Factor VIII Processing including Centrifugation, Column Chromatography
Work Experience
September 2017 – October 2017 Meggitt Control System Simi Valley, CA
Quality Engineer (Temporary employment through CDI Corporations)
Driving the closures of past due & aging non-conformance records (containing root cause investigations, corrective action, and effectiveness check) by running and managing the Corrective Action Board (CAB) meeting activities to facilitate collaboration between the inter-departmental department leaders and the quality engineers owning the records.
Performing preliminary reviews of the past due and aging non-conformance records to be final approved by Quality Manager and Quality Director.
Facilitating the transition of non-conformance records management from the older Microsost Access database to the new software QPulse system by working with the corporate QPulse system administrator and quality engineers using the new system, to ensure all the features and requirements needed by the facility are addressed.
Support daily manufacturing operations by attending and owning action items from daily layered accountability (DLA) meetings related to supplier quality engineering functions. Contacting and working with suppliers for any defects parts received to address the root cause and corrective actions required.
Extract data and create graphs from Material Review Request (MRR/non-conformance) system, Cockpit (customer returns/escapes) system to support Quality Manager and Quality Director in measuring and assessing the health of the facility’s quality system.
Working with Quality manager assigned to the Airbus quality program to address all the applicable standards (e.g. GRESS), improvement programs, and other requirements imposed by the Airbus customer.
May 2009 – Jan 2017 Baxalta (Shire) Los Angeles Los Angeles, CA
Engineer II, Senior Engineer, Quality Engineering Associate III – Quality Operations/Quality Assurance Department
Actively involved during the discovery of a non-conformance to determine appropriate immediate actions to mitigate the issue and minimize product impact. Initiate & generate non-conformance records with Trackwise 8 program. Perform/approve initial investigation and risk assessment for event records. Determine impacted lots and place lots under JDE System Hold for physical tagging and coordinate efforts for notifications.
Review & approve DeltaV User Interventions, ICARs, Non-Conformance Events, and Out-of-Limits (OOL) Investigation and Product Impact Assessment Reports for accuracy and compliance to procedures, and release or reject as appropriate. Obtain resolution on areas identified as non-conformance and directly involved in the root cause investigation, corrective/preventative actions identifications, and effectiveness monitoring criteria determinations. Interpret and evaluate results in terms of acceptability to standards, procedures and regulatory requirements during review and approval of product impact assessment. Review effectiveness monitoring data and approve closure of non-conformances.
Coordinate the efforts between the Compliance Investigation, Technical Services, Process & Control Engineering, Manufacturing Engineering, Manufacturing, and Quality Release departments to ensure timely resolution of non-conformances prior to batch release.
Perform document change (DRA) review and approval for Manufacturing & Quality SOPs & Forms & Job Aids, Maintenance PMs & Forms, Engineering Functional Specifications.
Participate in FMEA process for DeltaV code changes and DMAIC Problem Solving process for Non-Conformance or OOL root cause investigations.
Perform protocol/study review and approval.
Perform Trackwise data query on a daily basis and perform Quality approver assignment.
Perform data mining, trending, and analysis of non-conformance investigation and corrective/preventative actions summary through Trackwise and DeltaV system to support audits.
Enforce GMP, GDP, SOP, and safety in the manufacturing environment. Observe personnel, processes, and documentation in real-time production. Make quality decisions regarding manufacturing operations and processes.
Partner with manufacturing departments in meeting facility goals. Directly involved in projects related to process improvement, cycle time reduction, and compliance risk reduction.
Provide guidance and coaching for the areas of responsibility for less experienced individuals within the quality operations department (including process and DeltaV training).
April 2007 – May 2009 Baxter BioScience Los Angeles Los Angeles, CA
Engineer I & Engineer II – Manufacturing Engineering Department
Collaboratively work with Manufacturing and Quality to make a balanced decision to maintain manufacturing schedule/fulfillment goals and uphold safety/product quality impact.
Support daily manufacturing operations by applying DeltaV control system and Fractionation knowledge to investigate, identify, troubleshoot, and resolve any DeltaV codes (by following user intervention procedures) or process issues to prevent/reduce manufacturing delays, product non-conformity, and operational safety.
Generate and implement corrective or improvement measures in DeltaV (through change control process) to reduce margin of error and to optimize process yield and manufacturing cycle time.
As the Filter press and AZO Manufacturing Engineer System Owner, perform comprehensive process and DeltaV code review, assessment, and approval of any change control record pertaining to filter press or AZO operation to prevent any negative impact on manufacturing cycle time, safety, or product quality.
October 2006 – April 2007 Baxter BioScience Los Angeles Los Angeles, CA
Quality Associate II – QM Operations Department – Bulk Manufacturing (Albumin Processing and AHF-M)
Review documentation for accuracy and compliance to procedures, and release or reject as appropriate. Obtain resolution on areas identified as non-conformance. Interpret and evaluate results in terms of acceptability to standards, procedures and regulatory requirements.
Enforce GMP, GDP, SOP, and safety in the manufacturing environment. Observe personnel, processes, and documentation review in real-time production. Make quality decisions regarding manufacturing operations and processes.
Partner with manufacturing departments in meeting facility goals. Support the discovery, immediate corrective actions, root cause investigation, product impact, and closure of exceptions. Track, trend, and analyze exceptions to formulate effective corrective actions. Monitor effectiveness of corrective actions and preventive actions for non-regulatory/regulatory audit items.
Initiate & issue non-conformance record with Calibration Manager program.
Assist in the investigation and closure of non-conformance reports, corrective actions and out of limits (OOLs).
September 2005 – July 2006 Kelly Scientific Resources Los Angeles, CA
Technical Service Associate – Baxter BioScience
Execute Human Derived Butyrylcholinesterase (HU-BChE) protein purification processes: Filter Press, Ion Exchange Q Hyper D Column Chromatography, Affinity Procainamide Column Chromatography, Nanofiltration, Ultrafiltration/Diafiltration, Sterile Filtration
Execute large scale buffer preparation processes, including pH & conductivity measurement
Execute CIP & SIP cleaning procedures
Apply technical knowledge to perform complex trouble shooting task & assist during the transfer of new technologies into manufacturing
Organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills
Adapt to assignments of the various phases of process development, beginning with initial training to commissioning, validation and conformance lots
Skills
Microsoft Office: Word, Excel, Power Point, Access, Outlook
Trackwise 8, Calibration Manager, and JDE Quality Systems
DeltaV Control System
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