Business Development/Quality Assurance
Resume:
Briana R. Pridgen
Raleigh, NC *7610
*************@*****.***
SUMMARY
Experienced Quality professional with over 15 years of laboratory testing experience and 4 years in data review, including 3 years as a senior reviewer overseeing Quality Assurance (QA) activities. Skilled in Standard Operating Procedure creation and editing, and TrackWise deviation and Corrective And Preventive Actions systems. Proven ability to ensure regulatory compliance and data integrity. Recently supported business development initiatives and now seeking to return to a hands-on QA role in a laboratory-based environment.
EDUCATION
North Carolina State University, Raleigh, NC
B.A. Chemistry, December 2002
WORK EXPERIENCE
Asymchem (May 2022 - November 2023, Account Manager). Asymchem is a Contract Development and Manufacturing Organization in the biopharmaceutical industry.
Responsibilities:
●Serve as liaison between Asymchem Business Development (BD) and client/customer
●Prospect for new business (using Zymewire, Sales Navigator and LinkedIn)
●Serve as liaison between Legal and BD to ensure contracts are complete
●Complete Requests For Proposal (RFP)
●Properly file/store RFPs and contracts
●Schedule/attend customer facing meetings
●Ensure accounts are complete/up to date in SalesForce
Catalent Pharma Solutions (October 2006 – May 2013 Employed as an Associate Scientist; May 2013- May 2022, Scientist). Catalent Pharma Solutions is a Contract Research Organization in the pharmaceutical industry.
Responsibilities:
●Analyze compounds by various HPLC/GC methods
●Document data according to cGXP guidelines, maintaining compliance with company Standard Operating Procedures (SOPs) and cGXP regulatory requirements
●Review, interpret and trend analytical data
●Interact with analysts, Project Directors, Quality Assurance and customers to provide excellent service and meet deadlines
●Perform audits to ensure compliance (laboratory and documentation)
●Provide support for audits by governing bodies (FDA, MHRA)
●Read, write and edit methods, protocols and SOPs
●Mentor/Train new and junior employees
●Technical Quality review of data and documentation (ALCOA+, denoting Out Of Specification and Out Of Trend data; saving rework and incorrect reporting to customer)
Aided three major pharmaceutical companies in making their product suitable to put on the market for commercial sales
Briana R. Pridgen
1440 Ricochet Dr
Raleigh, NC 27610
*************@*****.***
TECHNICAL/WORK RELATED SKILLS
●Prospect
Zymewire, Sales Navigator, LinkedIn
●SalesForce
●Trackwise
●HPLC/GC
●Method Development/Validation/Qualification
●Karl Fischer Titration (Moisture testing)
●Osmolality/pH
●Viscosity
●FT-IR
●UV
●Foreign Particulate Matter
Manual microscope
Morphologi G3
●Particle Size Distribution by Impaction
Andersen Cascade Impaction
Next Generation Impaction
●Particle Size Distribution by Laser
Malvern Mastersizer
●Spray Actuation Content
NSx
●Electronic Notebook
●Technical Quality Review (Notebook/CoA/Text Report)
●MDI/DPI methods (Metered Dose Inhalation/Dry Powder Inhalation)
●Data Acquisition Systems
ATLAS
ChemStation
TotalChrom
Empower 3
●Participate in site safety committees
Ergonomics Committee
Spill Response
First Aid Response, Chairperson
SEMINARS
●Brookfield Viscosity training course (2011, 2012)
●24 Hour HAZWOPER Technician training (2012-2016)
●CPR/First Aid/AED (2017-2022, 2024)
Contact this candidate