Cynthia Gross

Regional Account Director @PSC Biotech® Corporation

Dallas-Fort Worth, TX, US

My job is to make your job easier - period.My company, PSC Biotech, is a worldwide consultancy with a focus on the life sciences industry with a concentration on keeping companies compliant in Quality - Regulatory - Validation. We execute projects in two unique ways: Assume total ownership of the project (from budget, timeline and deliverables) to providing individual consultants to supplement a clients team with additional resources including subject matter experts (SMEs) or other specific technical expertise.We are partnered with Lives International for data loggers. Used for temperature, humidity, CO2 and pressure validation, they are easy to use and have wonderful software to support the system. We also have a rental program for these.Quality compliance software products such as Audit Utopia (R) and Adaptive Compliance Engine (ACE)(R), which are used by 16 of the top 20 pharmaceutical firms. For smaller companies, we\'ve launched ACE Essentials(R)- Everything you need to get started - a turnkey, validated eQMS.The quality and integrity of our employees is the strength of our company.Specialties: GxP Supplier Audits, Project Management, GxP Software Development, GxP IT Infrastructure Qualification, Software Development, Agile/Scrum, Project Management, Cytotoxic Fill/Finish, Computer System Validation, Cleaning, Validation, Quality Systems, Process Control (Delta V), Risk Management/Assessments, Biotech Processing, Facility Design, Drying (Lyophilization /Freeze Drying), Fluid Bed, HVAC, BAS, BMS, LFH, DI, WFI, Clean Steam, SIP, CIP, COP, Autoclaves, Fermentation, Purification; regulatory submissions - 510K, PMA, BLA; PAI, QSR and FDA regulatory issues.

Louisiana State University and Agricultural and Mechanical College

Bachelor of Arts

Captain Shreve High School

HS Diploma