Susan Showers

Senior Quality Assurance Consultant


Ms. Showers has 23 years of experience within the Biologics, Pharmaceutical and Parenteral drug industries performing Quality Systems enhancements, remediation, and total overhaul/restructuring. She is an SME in the performance and review of quality documents such as CAPAs, Investigations/Deviations and Customer Complaints with extensive technical writing and data reviews skills for technical and manufacturing records (i.e., Batch Production Record review/generation, and SOPs). Ms. Showers also conducts various types of Quality related training in preparation for a client’s FDA and other agencies’ audits and helps with the generation, review and approval of standard operating procedures.

Susan has experience with developing new SOPs (from scratch) or remediating Quality Systems for small to medium size companies, in preparation for new product/PAI. She has extensive experience in technical writing and data review for batch records. She also performs quality related training in preparation for audits, such as performing investigations and SOP training.

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Core Competencies

  • Quality Auditor
  • Quality Training
  • GxP Quality Systems
  • GMP Audit Procedures
  • Biologics API
  • SOP Development
  • CMO/CRO Management
  • Clinical QA Design
  • Vendor Qualifications
  • Quality Agreements