Nicole Melzer - Interim Quality Manager, GMP and FDA Audit Preparation

With over 30 years of experience implementing and maintaining cGMP regulations, I support our clients in improving and streamlining their quality management (QM) processes. My passion for details, strategic and analytical mindset, and my creative, responsible team-player attitude set me apart. I prepare thorough GAP analyses and establish best-practice processes that meet guidelines - while remaining lean, efficient and practical.

• Implemented FDA regulations across the company and successfully passed the FDA pre-approval inspection

• Conducting external and internal audits
• Creating SOPs and technical documentation in STED format
• Improving risk management
• Assessing biocompatibility studies
• Validating ETO sterilization
• Quality improvement at a Japanese supplier
• Preparing for ISO 13485:2016, MDSAP and FDA audits
• Implementing MDR requirements
• Registrations in the USA, Canada and Japan
• Contact person for the notified body
• Training employees

• Supplier audits and quality improvements at peptide hormone primary packaging suppliers (syringes, vials and stoppers)
• Creating approval documents, specifications and lyophilization test strategies for reduced testing of primary packaging in aseptic filling

• Managing the lab
• Overseeing quality control, stability testing, and release testing
• CAPA and changes
• Supporting QC manager with qualifications and validations
• Creating SOPs and training
• FDA compliance

• QA, QC, production, planning, validation, development, and aseptic filling

• Deputy lab manager
• Lean Six Sigma advocate

• Lean Six Sigma Advocate