Rob Waters

About Rob Waters

I am a veteran quality professional that has held roles of increasing responsibility and influence for more than a decade in the pharmaceutical and medical device industry. I have experience leading organizations through remediations of FDA 483s and Warning Letter. I have spent my career in leadership remediating, simplifying, and streamlining what many would call “broken” business processes and practices that taken in totality lead to undesirable outcomes, like Warning Letters. I’ve led a career where almost no job description can adequately characterize the different roles and responsibilities that I end up taking on as I do not shy away from challenges. Earlier in my career, I spent a several as an individual contributor on the bench testing raw materials and finished goods for a variety of different dosage forms, which has provided me a strong foundational knowledge of GMP laboratories and analytical methodology techniques. In addition to my career experience, I have professional fluency in Spanish.

Experience

1. Associate Director Quality Assurance

   Noven Pharmaceuticals

   Mar 2022 — Present · Miami, FL, US

   In my role as Associate Director QA with Noven, I am serving as the QMR, complete with the responsivities that come with that job function. I have the duty to disposition materials and to lead Quality Board and Management Review meetings as required. I oversee teams in many different functional areas of Quality, including: document control, stability, supplier quality, internal audits, complaints, product surveillance (field alerts and recalls), and training. In my role as the QMR I also serve as the host of FDA Inspections and I lead the response to any FDA observations.

Education

• University of Nebraska-Lincoln

  Bachelor of Science (BS), Biochemistry

  2004 — 2008

• University of Nebraska-Lincoln

  Bachelor of Arts (BA), Chemistry w/ minor: Mathetmatics

  2004 — 2008

Skills

• Titration
• 21 Cfr Part 11
• Glp
• Usp
• Trackwise
• Laboratory
• Uv/Vis
• Ep
• Analytical Chemistry
• High-Performance Liquid Chromatography (Hplc)
• Quality Control
• Gmp
• Standard Operating Procedure (Sop)
• Potentiometric Titrations
• U.s. Food and Drug Administration (Fda)
• Change Control
• Raw Materials
• Pharmaceutical Industry
• Sop
• Fda
• Sap
• Starlims
• Investigations
• Karl Fischer
• Ftir
• Chromatography
• Capa
• Polarimetry
• Lims
• Hplc
• Validation
• Gc-Fid
• Gxp
• Empower
• Chemistry
• Apis
• Gc-Tcd