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Rich Soliven

@richsoliven

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Analytical life sciences quality professional driving compliance, validation, and process improvements.

United States

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What I'm looking for

I seek a role where I can apply quality systems expertise, lead validation and CAPA efforts, collaborate cross-functionally, and drive continuous improvement in a GMP-regulated environment.

I am an analytical life sciences quality professional with extensive experience in quality control, technical writing, root cause analysis, and regulatory compliance (ISO 13485, GMP, 21 CFR). I have led investigations of nonconforming materials, managed deviations and change controls in eQMS platforms, and presented findings to senior leadership to drive corrective actions and supplier improvements.

I have hands-on experience validating processes and materials, applying statistical tools (JMP, Tukey’s, t-tests) to QC data, and maintaining audit-ready documentation using systems such as TrackWise, MasterControl, and Veeva Vault. At Integrated DNA Technologies I implemented new analytical QC processes and reduced risk through trend analysis and proactive workflow improvements.

I emphasize cross-functional collaboration with R&D, manufacturing, supply chain, and external partners to support method development, scale production, and achieve regulatory certifications. I bring a practical, data-driven mindset focused on compliance, continuous improvement, and producing high-quality, reliable products.

Experience

Work history, roles, and key accomplishments

Current

Quality Specialist

Current

Endo Pharmaceuticals

Apr 2025 - Present (6 months)

Led investigations of supplier non-conforming material reports, closed NCMRs with root-cause CAPAs, and presented material defects to senior leadership to ensure product quality and safety.

Trackwise Root Cause Analysis CAPA Technical Writing

Quality Control Lead

Integrated DNA Technologies

May 2021 - Dec 2024 (3 years 7 months)

Led NGS reagent QC and implemented analytical QC processes, performed RCA on deviations, and used statistical analysis to drive QC improvements and supplier material validations.

NGS QC JMP Root Cause Analysis MasterControl Statistical Analysis Deviations

Quality Control Supervisor

Swi Biosciences

Mar 2018 - May 2021 (3 years 2 months)

Led QC functional testing and release of materials, developed QC processes and SOPs, and drove ISO 13485 certification and continuous improvement initiatives.

ISO 13485 SOP Development Process Improvement

Sr. Quality Control Specialist

Swi Biosciences

Jan 2016 - Mar 2018 (2 years 2 months)

Senior production member who updated QC/manufacturing documentation, optimized bulk formulations, and scaled production to reduce defects and rework.

Process Optimization Training Root Cause Analysis

Research Associate

Swi Biosciences

Oct 2014 - Jan 2016 (1 year 3 months)

Performed laboratory experiments, maintained notebooks and equipment, and managed consumables and safety training to support R&D and production projects.

Laboratory management Experimental Design Lab Safety Documentation PCR Data Collection

Lab Manager

Wayne State University School of Medicine

Jul 2011 - Jul 2013 (2 years)

Coordinated multiple research projects, maintained biospecimen databases and SOPs, and managed lab compliance and training for BSL-2 audits.

SOPs Biospecimen Tracking PCR Pyrosequencing Inventory Management

Education

Degrees, certifications, and relevant coursework

Wayne State University

Bachelor of Science, Biological Sciences

Bachelor of Science in Biological Sciences from Wayne State University with coursework and lab experience supporting molecular genetics and genomic research.