Amy Lederer Email & Phone Number

United States

• Managed a QA audit program ensuring compliance and inspection readiness, leading to improved quality solutions in a collaborative environment.• Oversaw a team to deliver risk management compliance and laboratory QA services, driving process improvement initiatives.• Developed staff and served as a strategic partner to internal operations for continuous improvements.

• Oversaw a QA audit program ensuring compliance and inspection readiness for internal and client processes.• Managed and developed staff to deliver quality solutions in a collaborative cross-functional environment.

Lead a team in delivering quality assurance, risk management, compliance and/or laboratory QA services. Assured internal and client processes and projects are compliant and inspection ready. Managed and developed staff. Ensured delivery of quality solutions in a collaborative cross-functional environment.

Conducted complex internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identified issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. Performed technical document review and other GxP practice activities in support of clinical development programs. Provided audit reports to management. Planned and delivered quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects.

Assured the quality of lab data reports associated with vaccine studies. Conducted complex internal inspections and audits to ensure compliance with establish quality assurance processes, standards, global regulatory requirements, and client contractual obligations. Identified issues impacting quality and integrity of research programs, determined root cause of non-conformance and verified CAPAs. Provided Aduit reports to others as required by standard GXP requirements. Planned and delivered quality services to support client deliverables.

Possessed a thorough understanding of laboratory procedures. Independently performed a variety ofcomplex sample preparation and analysis procedures to quantitatively measure pharmaceutical andbiopharmaceutical compounds in a variety of formulations and/or biological matrices. Followedvalidated or experimental analytical procedures with periodic direct supervision. Responsible forcompilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members. Routinely acted as the project leader on multiple projects, interacted with clients, reviewed and evaluated data, and wrote reports.

Development, transfer and validation of antibody-based assays on multiple platforms including ELISA, and meso scale detection.Operation of Tecan EVO systems. Analysis of preclinical and clinical trial samples from multiple clients.

• Preparation of course materials for teaching introductory biology classes (lecture, lab, and recitation)• Courses Taught: Recitation for Life Science 101 and Biology 151 Laboratory for Majors (included a lecture)• Engaging students to actively participate in class discussions and activities • Assessing student performance

Duties: • Molecular Techniques: DNA/RNA extractions, PCR reactions, electrophoresis gels, DGGE gels, MegaBase sequencer • Maintenance and supervision of long-term experiments, including field sampling and research • Equipment and method trouble shooting• Sample collection and sample processing, including use of autoclaves, centrifuges, pipettes, various drying ovens, CHN analyzer and chemicals to preserve the samples.• Preparation of various types of media (variety of agar plates, and bacteria broth) • Data Collection, including: raw field data, the use of microscopes to collect data, plate readers, and plate counting• Data entry and analysis – proficient in Excel, Sigma Plot, SPSS, JMP, PAST and word processing programs • Preparation of scientific presentations and journal articles

• Molecular Techniques: DNA/RNA extractions, PCR reactions, electrophoresis gels, DGGE gels• Preparation of various types of media (variety of agar plates, and bacteria broth) • Maintenance and supervision of long-term experiments, including field sampling and research • Equipment and method trouble shooting• Sample collection and sample processing, including use of autoclaves, centrifuges, pipettes, and chemicals to preserve the samples.• Data Collection, including: raw field data, the use of microscopes to collect data, plate readers, and plate counting• Data entry – proficient in Excel, Sigma Plot and word processing programs• Data analysis, preparation of journal articles• Supervision and training of undergraduate and graduate students• Daily lab tasks, including set up of a new lab (ordering of supplies, inventory, maintaining a budget, etc.)

• Worked on developing a new technique to assess community level physiological profiles in anaerobic communities• Responsible for determining problems and solutions with machines and the method

• Preparation of various types of media (variety of agar plates, and bacteria broth) • Maintenance and supervision of long-term experiments, including field sampling and research • Data Collection, including: raw field data, the use of microscopes to collect data, plate readers, and plate counting• Data entry – proficient in Excel, Sigma Plot and word processing programs

M.S., Envrionmental Microbiology

B.S., Biology