Linda Hoover Email & Phone Number

Tel-Aviv, Il

Tel-Aviv, Il

Pittsburgh, Pennsylvania, Us

Tel-Aviv, Il

Tel-Aviv, Il

Silver Spring, Md, Us

FDA Investigator/CSO in the Investigational Branch, Office of Regulatory Affairs, Philadelphia District Office. * Perform complex inspections of firms handling FDA regulated products: biological drug products/stem cells, clinical research trials (including devices), human tissue facilities, blood banks, drug manufacturers, dietary supplement manufacturers, and food manufacturers. * Enforce regulations. * Work towards compliance with the firms. * Communicate with various departments, different agencies, other team members. * Reference applicable regulations, compliance programs, guidance, and other resources. * Take on new and sometimes very difficult assignments, tasks, scenarios, and environments on a regular basis.* Present findings. * Write reports. * Maintain detailed notes. * Be flexible. * Travel.* Train others.

* Translation into bio/pharma: Director of Quality, Head of Production, Head of Facilities & Equipment (including maintenance, calibration, and repair), Head of Materials (including inventory control, warehousing, procurement, supply chain, supplier qualification), Head of Laboratory Control, and Computerized Systems* Designed 2 successful IVF labs* Oversaw all daily operations* Developed Quality Management and Performance Improvement program (including Document Control and Inventory Management). * Supervised staff* Performed hands-on work in the laboratory. * Built database for monitoring, tracking, and trending of data and problems. * Graphed, charted, and presented outcomes. * Worked with medical devices (catheters, etc). * Oversaw all IVF program operations including hands-on lab services, billing, equipment & supply purchases, vendor approval, equipment & process validations, hiring, training, data management, quality assurance & control, performance improvement, inventory control, document control, patient relations, safety, and accreditation. * Ensured compliance with all local, stated, and federal regulations. * Wrote all SOPs & policies. Designed all forms. * Designed 2 laboratories (1st IVF Lab in Mercer County, NJ; 1st lab built in 10 wks, CAP accreditation in 9 months). * Negotiated pricing reductions with vendors. Reduced start-up and operational costs. * Participated in promotions of infertility program.* Supervised and trained others.

Philadelphia, Pa, Us

Supervised and ran the IVF and Andrology Laboratories. Served as Acting Laboratory Director during several transitions. Went over Billing codes with a fine-toothed comb, resulting in possibility of increasing revenue by at least $100,000 / year. Managed laboratories. Built the database. Wrote protocols, policies, procedures. Hand picked to train in FDA regulations. Wrote and implemented the Quality Management program. Managed / monitored all aspects of the Quality Management Program.Acquired Board Certification as Embryology Laboratory Director.Trained in Embryo Biopsy and Preimplantation Genetic Diagnosis. Cofounded the 1st IVF Laboratory to provide these services with in-house Fluorecent In Situ Hybridization in Pennsylvania.

Responsibilities and duties of Embryologist, Andrologist, and Blood Lab Technician. Created Chemical Inventory Program. Had faulty equipment replaced for free. Achieved Board Certification as Technical Supervisor for both the fields of Embryology and Andrology.

All responsibilities of an Embryologist in an In Vitro Fertilization program. Assisted in designing and building the laboratory and in developing / promoting the program. Wrote procotols, policies, procedures. Wrote, published and presented scientific works. Readied the laboratory for inspection, passed. Built databases.Hand picked to learn new cutting edge techniques in micromanipulation. Trained all others in the lab. Wrote papers on Assisted Hatching. Am credited with the 1st babies resulting from ICSI in the Delaware Valley.

Philadelphia, Pa, Us

Cell and tissue culture, worked on research associated with multiple sclerosis. Animal husbandry. Explantations. SDS-PAGE electrophoresis, protein assays, affinity columns, DNA.

Ms, Biology

Bs, Education In Biology