Astrid Kaufman Email and Phone Number

• Generate development protocols and design of experiments (DOEs) to better characterize the coating and pouching equipment • Partner with cross functional teams and suppliers to drive continuous improvement and resolution of supplier related opportunities or issues.• Lead investigations related to product out of specifications nonconformances for Noven products • Use quality tools to find root cause to plan, implement, and to find immediate solutions and long term CAPAs (Corrective Action and Preventative Actions) activities• Develop and implement risk based approach for material qualifications conducted for commercial and in-development products at Noven.• Lead the improvement of Manufacturing Technical Service’s SOPs for compliance and department efficiency. • Lead pFMEA teams for major process equipment including coating and pouching equipment• Develop project charter and identified key stake holders as well as develop detailed timeline of activities in order to implement Process Analytical Technology (PAT) for coating equipment.

• Leading commissioning, qualification and requalification tasks for the major pieces of equipment and facilities such as transdermal laminate coating and pouching equipment, HVAC, compressed air generation and distribution systems and general area qualifications. • Generate protocols and reports, as well as executing IQ/OQ/PQ for equipment, facility, and utilities.• Develop and execute temperature mapping studies for product storage areas. • Develop deviation reports including the investigation, impact assessment and corrective actions in order to close the qualification activities in timely manner. • Collaborate and work significantly with cross functional groups including quality and manufacturing to resolve and rationale discrepancy in the validation documents

• Execute and complete improvement projects that improve quality, increase capacity, reduce scrap or reduce cost• Analyze and reengineer production layouts in order to improve process yields and rates. • Collaborate with manufacturing staff and management to develop, evaluate, and improve manufacturing methods and work instructions• Create and maintain product codes, routings, work instructions for projects and product lines. • Designing and implementing efficiency and quality improvement projects across production lines in order to mitigate scrap as well as performing at nominal specifications • Collaborate on new research and development projects/products with customer ideas and feedback• Equipment and process validations of textile equipment’s including: twisting, precision winding, dyeing, and braiding• Review and investigate CAPAs and NCRs issued by Manufacturing and/or Quality for various non-conformances. • Create/participate in developing process risk assessments and pFMEA’s• Responsible for process instructions, process validation, equipment qualifications, testing, material and process implementation and quality controls.• Develop new washing procedures and validations for efficiency and new regulatory requirements • Assign, manage and delegate projects to Suture Manufacturing Interns

• Creating and revising in-house SOPs for validations, IQ/OQ/PQs and process improvements. • Writing and executing the qualification and validation of equipment and processes used by Recovery and Processing Personnel under cleanroom conditions. • Optimization of freeze drying cycles to increase output capacity and overall efficiency for the birth tissue product line. • Process mapping to identify areas of improvement and implement new process procedures to reduce cost and increase productivity. • Worked on improving the process of the labeling and packaging of products. • Project leader on cleanroom cleaning validation, antimicrobial effectiveness studies, and bio-burden studies. • Space analysis to better optimize the space for various departments within the facility. • Experience with CAPAs, Customer Complaints, and NCRs. • Change Control engineering re presentative for documents related to validation protocols and equipment. • Coordinated new device transfer from R&D stage into productions. • Create project plans to ensure on-time completion of projects. • Project Manager for implementation of new microbiology culture methods with an outside microbiology lab, static mitigation in cleanrooms, autologous tissue process optimization. • Project lead on cleanroom, environmental monitoring, cleaning and processing validation. • Experience with aseptic techniques, root cause analysis and effective problem solving. • Project Manager of remediation projects for FDA and AATB audit responses.

• Fulfill the position of an engineering intern in order to restructure and ensure that all processes and standard operating procedures (SOPs) are FDA and AATB compliant. • Compiled data and performed statistical data analysis of donor records. • Write and execute IQ, OQ, and PQ protocols. Performed experimentations on method suitability studies, inhibition studies, and package validation studies. • Concentrated on developing packaging solutions for various existing products and launches. • Performed various market analysis reports for different supply and inventory purchases.

Assist in course content management/design, proctoring/coordination of exams, pre-recording of course lectures, studio classroom media equipment training. Assisted in HTML coding for the posting of course videos. Provided technical support to Professors for the recording of their lectures.

Provided consistent and high-quality customer service by assisting with the selection of merchandise, Maintained aesthetic appeal and organization of merchandise.

Scheduling appointments, maintaining chiropractic health records, greet patients and show them to adjustment rooms, perform ultrasound therapy on patients, and developing X-rays.