Sarah Kovar, Ms Email & Phone Number

Pensacola, Florida, Us

Oversees company-wide Quality Management System (QMS), maintaining compliance with PHS §361, FDA (21CFR1271), ISO13485, and AATB regulations.Facilitates third-party quality audits (ISO 13485, Orion Registrar) and annual internal audits.Rectifies internal non-conformances, deviations, and quality investigations, promoting prompt resolution of issues.Cultivates a culture of quality excellence through training, coaching, and recognition programs, resulting in improved employee engagement and retention.Demonstrates effective time management skills, handling multiple assignments simultaneously and meeting project deadlines.Maintains meticulous attention to detail, ensuring accuracy and completeness in all documentation.Reconstructed documentation compilation and archiving processes, ensuring traceability and compliance with regulatory requirements.

Pensacola, Florida, Us

Revised and maintained standard operating procedures (SOPs), work instructions, and validations.Worked in collaboration with medical director to determine donor eligibility per AATB standards.Involved in both quality assurance and quality control.

Pensacola, Florida, Us

Expertly processed human birth tissue within a sterile environment, employing aseptic techniques and meticulous adherence to stringent protocols to ensure product integrity.

Pensacola, Fl, Us

Conducted studies on bacterial communities and their role in chemical degradation of nitro-aromatic compounds in contaminated ecological sites.Identified and quantified chemicals using HPLC analysis.Developed standards, performed preventative maintenance, and updated HPLC hazardous chemical waste stream.Carried out microbiological biodegradation assays.Grew bacterial strains in selective evolutionary pathways using aseptic and microbiological techniques.Managed overall laboratory workflow, including purchasing of supplies, making media, writing SOP's, etc.Maintained accurate and detailed accounts of data through regularly writing reports.

Santa Fe, New Mexico, Us

Worked in an innovative, fast paced, discovery-oriented environment.Juggled several projects simultaneously to meet company goals.Established and maintained interdepartmental collaborations that included science, business, finance, regulatory, and analytical.Instituted new BSL-2 in-vitro mammalian cell culture department, including preparation of budgetary reports, purchasing equipment and supplies, acquisition of cell lines, establishment of cell maintenance, and development of protocols.Independently developed, implemented, and performed in vitro ADME- Tox studies.Developed Caco-2 cell permeability and toxicity protocols, reports, and presentations.Edited regulatory reports for preclinical in-vitro pharmacokinetic studies.

Dayton, Oh, Us

Graduate thesis study to determine the efficacy of small molecules targeting mutated oncogenic proteins (K-RAS).Cultivated working collaborations between biochemistry and organic chemistry departments.Performed in-vitro drug discovery assays to target oncogenic proteins in mammalian cells.Collected images with confocal and electron microscopy; analyzed data using ImageJ.Mammalian cell culture (BSL-2) experience included: MDCK and BHK cell lines; non-small cell lung cancer cell lines H522,H1975, H1299, H23, H441, H358, and A549; and non-cancerous human epithelial BEAS-2B.Molecular Biology techniques included DNA purification, Western blot, preparation of DH5α competent cells, bacterial transformation, Lentivirus transfection, and BCA assay.

Kettering, Ohio, Us

FDA registered, ISO 13485 certified, AATB accredited, class 100 clean room processing facility aimed at producing HCT/P medical grafts.Performed aseptic techniques to process skin and specialty bone grafts.Produced high quality products in conformance to OSHA, COLA, and AATB standards using current good manufacturing practices (GMP).

Graduate Certificate, Regulatory Science

Master Of Science - Ms, Biochemistry And Molecular Biology

Bachelor Of Science - Bs, Biology, General