Phynese Lewis, CQA (ASQ), LSSGB

Associate Principal Consultant

Phynese Lewis is a quality assurance, compliance, and process improvement consultant with over 20 years of experience with extensive knowledge of GxP, healthcare, and pharmaceutical regulatory requirements. Her project management and team building experience have proven essential in implementing system wide initiatives. She is a certified quality auditor and leads supplier/vendor audits for pharmaceutical/biologic companies for products in clinical trials or commercially available and has managed audits from the planning stage through the audit response process and CAPA implementation. She serves as subject matter expert in cGMP, cellular therapy (GTP), patient safety, product manufacturing, and testing. Quality Management Systems experience includes development of SOPs and CAPA management and working with vendors to resolve customer complaints. She previously served as a quality assurance consultant for start-up laboratories for clinical research organizations/CLIA accredited labs by coordinating auditing and compliance related activities. Phynese has a B.S. in Biology from Chowan University.  She maintains a certified quality auditor (CQA) certification and a Lean Six Sigma Green Belt (LSSGB) certification.