Featured Member: Darryl Prater on HBCU CONNECT!

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Q&A With Darryl Prater

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Darryl Prater
QA Data Integrity, FUJUFILM Diosynth Biotechnologies
Location: Millersville, MD United States
Joined: Mar 5th, 2010

About (request update)

My Interview Question

What is your passion?

Education (request update)

Fisk University class of 1987

Undergrad Major: Chemistry

Experience

I currently work with FUJUFILM Diosynth Biotechnologies as QA Data Integrity
I have 20 years of experience working in the Manufacturing and Production industry.

Lead Specialist, QA Validation | Catalent Pharma Solutions
From January 2023 to Current • 3 year(s)
Provides continuous improvement support to process, equipment, utilities and computer systems. Serves as Data Integrity SME working on validation lifecycle documentation and CFR 21 Part 11 compliance.

Senior Specialist, Validation | Accenture
From April 2013 to November 2022 • 9 year(s)
Authored validation test documentation including IQ, OQ, and PQ protocols for internal projects. Acted as QA Lead for client-specific data protection projects and mentored junior validation team members.

IT CSV Analyst | McNeil Healthcare
From December 2012 to April 2013 • 1 year(s)
Designed, created, and maintained technical CSV documentation. Worked with IT CSV Leads to define scope and execute system test scripts.

SQA/Validation Specialist | Philips Healthcare
From July 2011 to July 2012 • 1 year(s)
Supported ERP Quality systems, software, and database validations for TrackWise and SAP modules. Facilitated analysis and documentation of User Requirements and Functional Specifications.

Quality Assurance Specialist | Registrat-MAPI
From August 2010 to January 2011 • 1 year(s)
Responsible for oversight of Quality Assurance System to ensure regulatory and GCP compliance. Conducted internal, external, and vendor auditing while developing SOPs and validation documentation.

Sr. IT Analyst â Manufacturing | Eli Lilly and Company
From January 2003 to December 2010 • 7 year(s)
Led compliance efforts for Quality Control Laboratories and served as SME for regulatory inspections. Managed global upgrade of MARS-Maximo asset management suite and led large remediation efforts.

Instrument / Computer Specialist | Pfizer-Pharmacia
From May 1998 to November 2003 • 5 year(s)
Maintained analytical instrumentation and managed validation responsibilities for Chromatography Data Systems. Member of 21 CFR part 11 Site Team and managed compliance training programs.

Metrology Liaison/Process Analytical Chemist | GD Searle / Monsanto
From January 1996 to May 1998 • 2 year(s)
Calibrated instruments and performed qualification and validation testing. Handled department move logistics and worked with Lab Automation as Data Acquisition super-user.

Process Analytical Chemist | GD Searle
From April 1994 to January 1998 • 4 year(s)
Tested in-process and final products using chromatography methods. Performed method development, validation, and instrument maintenance while participating in improvement teams.

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