Doug Leek

About Doug Leek

I’m a seasoned biotechnology professional with a wide range of experiences within the industry. This experience includes Quality Assurance, tech transfer, manufacturing, and Nonconformance (NC) investigation.Throughout my twenty two years of biotech experience, I have gathered extensive knowledge in cGMP’s and a “sixth sense” for noticing compliance issues. I’ve put this knowledge to good use by participating on inspection readiness teams, QA audits, acting as a runner during regulatory inspections, and reviewing batch records. As a manufacturing associate, my attention to detail earned a reputation for error free processing.As a NC/CAPA specialist at Amgen, I received top-notch training on the elements of writing a solid deviation report. This included advanced training in performing thorough investigations, root cause analysis (RCA), product impact analysis, and effectively building the case with excellent writing skills. In my current position as Specialist Manufacturing, I work primarily on helping to solve process-related manufacturing issues through RCA, investigation writing, and corrective action (CAPA).

Experience

1. Senior Investigation Specialist Ii

   KBI Biopharma

   Oct 2022 — Present · Raleigh-Durham-Chapel Hill, NC, US

Education

• Southwest Baptist University

  B.S., Biology

  1987 — 1991

Skills

• Validation
• Biotechnology
• Protein Purification
• Trackwise
• Corrective and Preventive Action (Capa)
• Regulatory Requirements
• Ind
• Pharmaceutical Industry
• Sop
• Deviation Management
• Fda
• Quality Assurance
• Gxp
• Chromatography
• Aseptic Processing
• Sharepoint
• Regulatory Affairs
• Lifesciences
• Purification
• Editing
• Fermentation
• Vaccines
• Quality Control
• Gmp
• Aseptic Technique
• Microbiology
• Lims
• Drug Development
• Biopharmaceuticals
• Regulatory Submissions
• Quality System
• V&V
• Document Management
• Delegation
• 21 Cfr Part 11
• Change Control
• Project Management
• Computer System Validation
• Glp
• Root Cause Analysis