Quality Engineer

• May 2022 - Present

Sr. Quality Assurance Associate

• Mar 2021 - May 2022

Quality Control Associate 4

• Jun 2019 - Mar 2021

- Liaison for collaboration between Purchasing, NPI, Finance, Supply Chain, and Sustaining Quality to carry out and support a new purchased finished goods process and an updated RMA process. - Implements sustaining quality activities to prevent upstream issues- Performing team scheduling activities; managing cross-functional and internal communication to ensure timely release of critical components for production and development builds- Developed and implemented a team application for scheduling and metrics tracking- Reviews and approves engineering records pertaining to incoming critical components for production and development builds- Reviews completed in-process and finished goods batch records and associated data for product release; ensuring GDP accuracy and completeness prior to release- Provide support in reviewing non-conformance implementation activities to ensure adequate investigation and verification- Standardized and optimized training and onboarding process; trains and onboards new personnel in IQC inspection, batch record review and release, and to align with cGMP standards- Supporting internal and external audits Show less

Quality Control Associate 1/Quality Control Associate 3

• Aug 2017 - Jun 2019

- Performed raw material inspections and verified that production lots met visual, certificate of analysis, or functional and analytical test requirements and acceptance criteria prior to product release- Performed routine and non-routine analytical biochemical and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates and final goods- Initiated non-conformance reports and performed non-conformance activities associated with critical component reagents- Experience with High Performing Work Team structure, reporting team process KPIs, driving improvements on first pass yield metrics, and promoting safety awareness Show less

Manager's Assistant - Text Department

• Sep 2014 - Aug 2017

Maintain, update, and file invoices, receipts, and other files regarding book buying. Work as the liaison between departmental staff members and book buying companies; general customer service Maintain, update, and file invoices, receipts, and other files regarding book buying. Work as the liaison between departmental staff members and book buying companies; general customer service