Labvantage LIMS Operations Specialist Resume San Diego, CA - Hire IT People

SUMMARY:

Biomedical Engineer that learns quickly and takes on challenges with the objective of making a significant impact.
A dynamic collaborator who is highly motivated and a persistent worker that takes initiative to learn and produce results, while maintaining a great focus on detail. Resourceful, analytical, and persistent with strong communication skills. Additional experience in numerical modeling, software development, and statistics.

TECHNICAL SKILLS:

PROFESSIONAL EXPERIENCE:

Confidential, San Diego, CA

Labvantage LIMS Operations Specialist

Created over 100+ new test methods to ensure a timely release of product
Reviewed and provided input on all new testing procedures in a regulated environment
Completed over 25+ new test methods to facilitate new shelf life and annual monitoring stability studies
Implemented a process improvement project that reduced labor cost by 1 hour per test for 16 different products
Managed a team that implemented QC testing for 9 new product lines over the course of 1 year
Maintained LIMS master data for 400+ test methods spanning 200+ products
Developed 50+ real time trending dashboards that alerted users when material fell out of trend
Designed SQL queries to extract key data to support ongoing material investigations and date extensions

Confidential, San Diego, CA

Stability Quality Control Support Analyst

Achieved proficiency on 30+ assays to support multiple testing groups
Developed protocols for shelf life and annual monitoring studies
Reviewed and approved reports for 510k and regulatory affairs annual submissions
Conducted investigative testing and generated reports assigning a root cause
Implemented 8 new process improvement projects reducing operational cost by $2000 a month
Ordered, collected, and organized an average of 8 new stability studies a month
Managed inventory for over 200 active studies
Trained new employees and developed guides for incoming stability analyst

Confidential, San Diego, CA

Biological Quality Control Technologist

Performed PQ testing on 4 new products to validate the manufacturing process at a new site
Reviewed all Device History Records for accuracy before delivery to Quality Assurance
Performed environmental monitoring and clinical testing each week for newly manufactured lots
Documented out of specification results and performed necessary investigations and retests
Conducted system suitability and recalibration on release testing instruments each week
Tested finished goods and raw materials across 9 different assays to ensure all specifications were met
Operated and maintained notebooks and inventory for Quality Control Retain materials