SUMMARY Highly motivated, goal oriented, and efficient Quality Assurance professional with expertise in regulatory compliance, documentation, auditing, and process improvements. Known for ability to complete multi-faced tasks within strict time constraints. Demonstrated expertise in setting priorities and establishing appropriate detailed documentation to meet deadlines using strong clinical, analytical, and technical skills to analyze complex processes and problems to develop innovative solutions to challenges. PC literate with working knowledge of MS Office Suite, Windows XP, and Internet Excellent organization, communication, analytical skills, and research abilities. Able to read, analyze and interpret general business periodicals, professional journals, technical procedures and governmental regulations (GMP, GLP GCP, ISO) Excellent time management, interpersonal and communication skills, Knowledge of quality assurance, GMP, GCP, GLP, Product testing, In-Process control, Process operations, experimental techniques and technical documentation, process optimization and validation, cleaning validation on equipment, development and validation of analytical methods, and FDA regulations, Familiarity with US Pharmacopoeia, audit and non-conformance reports for in line and in process tests, audits of the QC lab, Reviewing laboratory records, corrective/preventative actions, raw materials specification, writing SOP's, day to day operations, calibration physical tests, identity tests, assays, Familiarity with sampling methods and applications, validation of analytical methods, safety and waste management, chemical handling and disposal, proficiency with Microsoft Office (Word, Excel, and Power Point), and maintenance of the employee training program. Work effectively with employees at all levels at the site regarding Quality Management Systems development, Internal Auditing, Compliance, CAPA and Management Review. Experienced in the Plan-Do-Check-Act methodology in improving the processes in the quality management system.

Highlights:

• Quality
• Quality Assurance
• Quality Control
• Audit
• Complaints
• ISO
• ISO 9001
• Management
• Protocol
• Manufacturing
• ISO 13485