I have experience managing quality management systems in regulated industries including pharmaceutical and medical device manufacturing, GMP and GLP, laboratory testing, and cleanroom monitoring as well as strong technical writing skills.
Overview
12
12
years of professional experience
Work History
Director of Quality
Rose Plastic Medical Packaging USA, L.L.L.P.
08.2022 - 02.2025
Audit and quality system management for ISO 9001 and ISO 13485 certification
Quality Management System maintenance (document control, document revision, training)
Calibration tracking of quality test equipment in SAP (used as a Calibration Management System), CAPA risk assessment in case of out of tolerance test equipment, trending of calibration results
Supervise and mentor Quality Associate
Monitoring of ISO 9 and ISO 8 cleanrooms (environment for plastic molding)
Handling and investigation of customer complaints
Support requests from customers for audit, quality surveys, product information, Quality Assurance Agreements
Production equipment qualification
Approval of investigational testing
CAPA process owner
Coordinate Quality Management Systems with Headquarters in Germany
Release of raw materials
Sr. QA Laboratory Specialist
Tolmar, Inc
04.2020 - 07.2022
Instrument calibration and requalification protocol and report review and approval, impact assessment in case of out of tolerance results or equipment failure
Reviews and approval of Laboratory Investigations (Phase I (lab) and Phase II (manufacturing) for OOS results) for sterile injectable products (filled syringes) and dermatology products
Attend planning meetings to support release of product and compliance to timelines
Regulatory assessment within three business days to determine if Field Actions are required in US or are communicated to domestic or international marketing partners
Review and approval of document changes and document change request
Change control impact assessment, review, and pre and post approval
Instrument requalification protocol and report review and approval
Approval of investigational testing
CAPA and effectiveness check identification, effectiveness check approval
Coordinate on development of training materials
Audit support (QA review, back room, preparation)
Provide mentorship to junior team members and to investigators
Regulatory Reporting Specialist (Contract through Modis Engineering)
Cook Medical, Cook Endoscopy
01.2020 - 04.2020
Complaint handling for endoscopy medical devices
Regulatory assessment and reporting for malfunctions and adverse events to domestic and foreign regulatory agencies
Deviation Investigator (Contract through New Age Systems)
Sandoz, a Novartis Division
11.2018 - 01.2020
Investigation of deviations for solid oral dose, cleaning processes, controlled environments and packaging operations
Deviation report preparation/technical writing
Identification of corrective and preventative actions (CAPAs) to address root cause of deviations
Determination of product impact
Complaints investigation – technical complaint handling/investigation of manufacturing processes
Quality Engineer/QA Associate III
Baxter
09.2017 - 10.2018
Investigation of non-conformances and deviations
CAPA ownership/change controls/document changes
Validation of equipment changes and new equipment for flexible container unit
Remediation for FDA warning letter
Quality Investigator (Expatriate position for 2 years) – Hospira Healthcare Pvt. Ltd.
Pfizer
09.2015 - 09.2017
Approver for laboratory and deviation investigations, provide oversight for identification of corrective and preventative actions, perform Notification to Management for critical investigations, main approver for chemistry laboratory and manufacturing science and technology departments (analytical section).
Areas of focus: QC laboratories, equipment and calibration, engineering maintenance, procedural gaps, validation issues, method transfer, out of specification (OOS) Phase I (lab) and Phase II (manufacturing), lab data systems, data integrity, and human error
CA/PA (Corrective and Preventative Actions) – improvement to laboratory systems for instrument calibration/qualification, procedure improvement to reduce error, resolution of vendor issues (API, raw material and packing material)
Mentor investigators and QA team members for technical writing in English, root cause analysis techniques, identification of realistic CA/PAs, and scope of product impact, measurement of CA/PA effectiveness
Quality Investigator/Quality Engineer
Hospira
09.2013 - 09.2015
Investigation of out of specification results (Phase I and II), equipment/instrument failures, and procedural deviations for the chemistry quality control lab
Provide writing support for other investigators
Perform product impact assessments within required timeline
Change control, SOP preparation, training
Gowning certification for controlled production areas
Purchasing of supplies and reagents for Chemistry laboratory according to approved supplier list
Lab walk through for audit readiness, compliance to procedures
Engineer II/Technical Support Engineer (Contract position)
Merck and Co.
01.2013 - 09.2013
Lead cross-functional quality investigations and identify CA/PA
Areas of focus: Automation Events, validation errors, environmental excursions, utility alarms, human error, batch record error, equipment failure, out of tolerance events for instrumentation
Developed working knowledge of aseptic processing and vaccine manufacturing process for bulk and fill/finish lyophilization to assess quality impact to product