USA Pharmaceutical Industry (Highly Regulated FDA industry) Technical Reports Expert Writer -- 2

I need you to write a report several reports when asked. They are technical writing on Quality Systems on the USA Pharmaceutical environment. Quality Professional with experience of quality management, regulatory compliance and interpretation, and analytical laboratory experience within quality focused global environments. Assurance ● Compliance ● Improvement SUMMARY OF QUALIFICATIONS • Established quality consultant with diverse background in auditing, quality management system implementation and maintenance, training, corrective and preventive action, root cause analysis, management of change, statistical process control and analysis vendor management. • Skilled auditor certified in numerous disciplines and standards (ISO 9001, ISO 13485, ISO 17025, IPEC, ICH, SQF 2000, FDA Good Manufacturing Practices and Good Laboratory Practices). Audit experience includes excipient and active pharmaceuticals, medical device, biotechnology, chemical, specialty chemical and petrochemical manufacturing, packaging components, distributors, warehouses, and laboratories. • Experienced technical writer. Writing projects include quality manuals, standard operating procedures for quality, analytical, manufacturing, purchasing, maintenance, shipping & receiving departments, and Type II and Type IV Drug Master Files. • Laboratory professional with experience in petrochemical, chemical, and pharmaceutical analysis. Background includes wet chemistry, HPLC, GC, ICP-MS, ICP-AES, IC, FT-IR, UV-VIS, nitrogen & sulfur analysis, autotitration, particle size and laboratory operating systems. Educated in molecular biology techniques such as Western blots, ELISA, SDS-PAGE, PCR. • Regulatory specialist with expertise in excipient and bulk active pharmaceuticals. Compliance activities encompass laboratory systems, quality assurance, documentation & records, validation (software, process & analytical) and qualification (analytical instruments & manufacturing equipment). • Project experience encompasses ISO 9001 and SQF quality system certification, cross-departmental statistical process control programs, employee training programs, pharmaceutical complaint investigations and stability testing programs PRIMARY INDUSTRIES Pharmaceutical, specialty chemical, excipient, petrochemical, semiconductor, medical device, food ingredients and general manufacturing EDUCATION Biology Pharmaceutical GMP Professional