Amanda Curtis Email & Phone Number

Provide consulting services for the pharmaceutical industry with a specialization in environmental monitoring, contamination control, and microbiology.Develop and deliver training on topics such as environmental monitoring, microbiology, aseptic technique, APS design and theory, and root cause analysis.

Houston, Texas, United States

- Owned and investigated EM excursions, adverse trends, and deviations. - Performed EM data review and trending, authored EM trend reports. - Performed post-EMPQ location assessments. Designed and created routine EM plans. - Owned and implemented CAPAs and change controls pertaining to environmental monitoring.

Houston, Texas

- Owned and assisted with deviation investigations, CAPAs, change controls, and laboratory investigations for all of QC. - Performed and assisted with complex technical investigations using routine and advanced root cause analysis tools.

Bothell, Wa

- Perform facility environmental monitoring in ISO 7-9, including data trend analysis. - Assess ISO 5 in-process EM for accuracy and adverse trends. - Investigate excursions and deviations. - Write and edit SOPs and validation protocols. - Led method validation/PQ of rapid sterility testing using filtration methods and isolator technology.

Redmond, Wa

-Performed daily tasks of QC Microbiologist. -Coordinated and oversaw workflow and ongoing projects among 4 other QC Microbiologists.-Wrote new SOPs. -Assisted with lab-related projects concerning the merging of Nutraceutix and Probi AB.

Redmond, Wa

-Performed viable counts and pathogen screening on raw materials, in process materials, and finished product. -Followed FDA and NSF regulations and guidelines. -Reviewed testing related documents and results for accuracy and quality control issues. -Reviewed and updated SOPs

- Screened donated blood for infectious diseases and abnormal antibodies using automated techniques, including nucleic acid testing. - Typed donated blood using both manual and automated techniques. - Followed FDA, CAP, HIPAA, AABB, CLIA, and OSHA regulations and guidelines, including cGMPs and cGLPs. - Reviewed testing-related documents and results for accuracy and quality control issues.- Maintained and troubleshot automated systems.

- Trained new laboratory assistants and medical technicians in sample setups. - Assessed competency per CAP guidelines.- Coordinated and oversaw workflow among five to six assistants while performing all routine duties of a laboratory assistant. - Served as a resource person for assistants and technicians. - Verified orders and special requests with pathologists, surgeons, and nurses.- Served on several committees with members of various departments within ACL. - Responded to quality control concerns with department emails, action plans, or procedure changes. - Completed ACL Laboratories Leadership Development Program. - Initiated and took part in a 5S/Lean project within the department.

- Received, labeled, and processed biological samples in the central microbiology laboratory for Aurora hospitals and clinics around the state of Wisconsin. - Aseptically processed and plated urine samples, throat cultures, bodily fluids, wound swabs, stool samples, and tissue samples for culture, sensitivities, gram stain, and/or PCR. - Routinely worked under Biosafety Level 2 conditions, and occasionally worked under Biosafety Level 3 conditions. - Routinely used Commercial Lab, Sunquest, Copath, Cerner, Epic, and Fast software.- Collected and analyzed statistical data on samples using the Microsoft Office Suite. - Stayed up-to-date on HIPAA and OSHA requirements as they pertain to the laboratory.

- Made and sterilized solid and liquid media for bacterial and protozoal cultures.- Assisted with FAME preparation and analysis of samples.- Performed established assays and experiments under minimal supervision.- Operated standard laboratory equipment.- Handled and disposed of radioactive isotopes. - Followed and maintained standard operating procedures for a microbiology laboratory under minimum supervision. - Transferred bacterial and protozoal cultures from various media using sterile technique.- Handled biohazard wastes.- Kept detailed notes in notebooks and Microsoft Excel. - Kept an up-to-date inventory of chemicals and laboratory supplies.