Sarah Hepler Email & Phone Number

San Luis Obispo, Ca, Us

San Luis Obispo, Ca, Us

Rosemont, Illinois, Us

I took a career break to focus on my MS in Quality Assurance.

Santa Maria, Ca, Us

>Complete customer quality surveys -Use knowledge of ISO 13485 and FDA regulations -Research internal documentation -Communicate with process owners -Provide supplier documentation.>Communicate with customers regarding supplier quality agreements -Coordinate completion of new agreements -Reduce non-value-added work by updating expired documents>Inspect manufacturing batch records for accuracy and compliance -Identify unplanned deviations for trending and track in MS Excel>Participate in internal audits. -Interview employees, review batch records, logs, training, and SOPs.>Perform risk assessment for changes to company documents. -Interpret quality agreements and communicate with customers -Draft change notification letters concerning changes in product or processes>Draft customer notification letters and communicate with customers on any additional inquiries concerning notifications.>Compile pre-submission for Class II device -Research and determined testing necessary -Plan analytical bench testing and clinical trials -Write detailed protocols, datasheets, and flow charts>Address a deficiency letter by researching test methods and designing viral quantification studies, writing protocols and data sheets, and determining statistical test methods.>Review 20 customer complaints weekly -Perform risk assessment of failure -Review correspondence with customer -Justify mitigation measures -Summarize MDR report for FDA -Use Salesforce and SmartSolve software for complaint tracking

Santa Maria, Ca, Us

At Hardy Diagnostics, I have become knowledgeable about the medical device industry, culture media, bacterial requirements, antibiotic resistance, antibiotic stability and lateral flow assays. My job duties include:-Troubleshoot culture media pilots to investigate and resolve non-conforming products.-Pilot new products and custom requests for internal or external customers.-Evaluate raw materials from primary or secondary suppliers for use in culture media and ensure timely completion of the appropriate documentation.-Perform in-house studies for new HardyCHROM products. This involves study design, data interpretation, and report writing.-Provide manufacturing support by recommending adjustments, submitting deviations, and completion of the appropriate change control documentation.-Utilize various resources such as CLSI M100, CLSI M02, CLSI M07, and USP to write protocols for CAPA investigation and closure.-Fill out customer quality surveys and edit IFUs as an introduction to the regulatory affairs environment.-Certified in the "Hardy Way" in Lean Six Sigma Yellow Belt and Project Management.-Certified to package and ship Division 6.2 Hazardous Materials.

Santa Maria, Ca, Us

At my internship at Hardy Diagnostics I primarily performed in-house 510(k) studies for culture media. I followed SOPs to challenge the medium, recorded data, and wrote detailed summary reports on the project.

At the Center of Applications for Biotechnology, I researched the genetic diversity of E. coli in the intestinal microflora of college-age women. My tasks included:-Making MacConkey and LB agar plates.-Isolating E. coli from fecal samples using MacConkey agar.-Use PCR to phylogenetically group isolates to group A, B1, B2, or D.-Use PCR to determine presence of virulence factors that cause UTI's in E. coli.

As a host and server at a sushi restaurant, I worked with the chefs and servers to provide excellent food and customer service.

Watsonville, Ca, Us

At the California Strawberry Commission, I learned aseptic technique and other microbiology skills before any of my university classes. My duties included:-Making potato dextrose pilots, acidified PDA, and other plated media to culture pathogenic fungi.-Dissect the crown and petiole of diseased strawberry plants across California for diagnosis.-Assist graduate students in their research of fungicides on soilborne pathogens such as Fusarium and Macrophomina.

As a crew member of Einsteins Bros Bagels, I took orders as a cashier or made sandwiches and espresso drinks to order. I learned teamwork to keep the restaurant clean and running smoothly.

Dallas, Tx, Us

At Which Wich I performed many duties including host and cashier. I would welcome customers into restaurant, and advertise our newest specials. I learned about the importance of customer service in making orders correctly, in addition to keeping aclean and stocked restaurant.

Fort Lauderdale, Florida, Us

As a seasonal retail sales associate, I welcomed people into the store with a friendly outgoing pitch. I would act as cashier as well as assist people in finding what they need. I restocked the store and recommending new products or promotions to customers.

Over the course of this summer camp for gifted children I would plan weekly activities with other program assistants and supervise children at breaks or during activities.I assisted the instructor in planning or giving lessons in addition to running errands for the instructor, setting up class activities, and taking notes for students' feedback reports.

Master Of Science - Ms, Quality Assurance

Bachelor’S Degree, Biology, Microbiology Minor

High School, High School