Roxann Augustine Email & Phone Number

Newark, Ny, Us

Victor, Ny, Us

Newark, New York, United States

Responsible for training sites with ISO13485 certification and FDA registration. Business Process Owner for the CAPA process and the Production Data Continuous Improvement process.

Newark, New York, United States

Manage the Quality Management System (QMS) for all areas of the company. IEC's Management Representative for: ISO9001:2015, AS9100:2016, ISO13485:2016, FDA, and NADCAP. Manage the internal and external audit processes as the method for continuous improvement. Oversee the Corrective Action process to bring any NCR's to closure in a timely fashion.

Farmington, New York, United States

Coordinated (and conducted as necessary) internal and external audits of the ISO 9001 quality system at Ultrafab. Worked with auditors and process owners to schedule the audits. Ensured the audits occurred as planned/scheduled. Ensured audits were brought to closure and coordinated any corrective actions required based on the audit findings. Utilized the software program to monitor audit progress. Focused on meeting required deadlines for internal as well as external audits. Continually monitored the procedures to ensure the quality system remained effective, capable and compliant with ISO 9001 standards.

Farmington, Ny

Identified opportunities to reach new customers and cultivate partnerships for our fluid transfer products and services. Created long-term value based on trust, respect and quality products/services in our commercial relationship. Our fluid transfer kits are designed for benchtop bioreactors. Our company can assemble the kits and provide them ready-to-use so your lab technicians can focus on more important duties in the lab. Utilized my knowledge in the biotech/biopharma market to provide economic and efficient solutions to our customers’ daily workflow.

Geneva, Ny 14456 Usa

Supported business growth and development of Tarsons Brand Products in the USA and Canada.. Developed and implemented internal programs to support distribution and direct customers while meeting growth, pricing and revenue objectives. Developed marketing programs focused on brand awareness.

Rochester, Ny, Usa

*Performed internal audits against the ISO 9001:2008 and ISO 13485 standards.*Supported internal and external customers regarding ISO and FDA regulations as they related to the Thermo Scientific consumable products. *Investigated and provided documentation regarding global regulations as they related to the Thermo Scientific consumable offering.*Utilized web-based reporting tool: SalesForce.com.

Rochester, New York

*Trained in-country specialists and distributor reps (in EE, ME, AFR, LA) on our Lab Specialty Products. *Met directly with customers in the labs to create end-user demand. *Developed and implemented product promotions resulting in increased brand awareness and sales. *Uitlized web-based reporting tool: SalesForce.com as communication link with sales team and customers. *Conducted many training presentations to audiences (sizes from 10 - 200 attendees).

Rochester, New York

*Managed the sales and marketing of our business outside the USA and Europe. *Implemented sales targets and promotional programs to increase our global market share.

Associate'S Degree, Liberal Arts And Sciences/Liberal Studies, 3.8

Education record

AS9100:2016 Lead Auditor ISO13485:2016 Lead Auditor MDSAP Lead Auditor ISO9001:2015 Lead Auditor Nadcap Audit Criteria Customer Service.