Amanda Burger Email & Phone Number

South Bend, In, Us

South Bend, In, Us

Morales Group – Ambu Noblesville, INDuties: Liason between Ambu and authorized dealers for sales processing system. Manage and upload monthly traced sales and rebate data into the PAT system. Perform rebate reconciliation for authorized dealers. Perform end customer mapping in the PAT system.Quality Control Analyst Duties: Support the registration of products in foreign countries. Wrote SOPs, SWIs, and forms for manufacturing and quality departments. Collected data, reviewed DHRs related to customer complaints. Closed customer complaints related to CAPAs. Manage the customer complaint database. Managed the submission of several hundred validation documents to document control. Member of FDA audit team. Wrote SOP and Standard Work Instructions for medical device manufacturing equipment.

Wrote 21CFR Part 11 compliance validation documents for Shimadzu Class VP software. Generated report templates on Class VP Software for sample analysis. Wrote SOPs for software usage and 21 CFR Part 11 compliance. Updated sample analysis SOPs to new practice.

Performed normal phase flash chromatography purification on organic synthesis products. Verification of identity of purified compound by LC/MS. Consulted with medicinal chemists to optimize the purification methods.

Stability testing of product using Agilient HPLCs and Gilson Liquid Handler. High volume sample preparation, data analysis using Total Chrom software. Asissted with method validation activities.

Princeton, New Jersey, Us

HPLC testing of clinical samples using UV, fluorescence, and Photodiode Array detectors. Method validation, method development, instrument qualification. Protein electrophoresis, capillary electrophoresis, and immunofixation electrophoresis. Responsible for writing, reviewing, and editing department SOPs and method validation reports. System Administrator for Waters Empower 2 HPLC software.

USP, EP, and JP testing of raw materials for pharmaceutical products utilizing wet chemistry techniques.

Assisted in the development of new analytical methods and supported various protein chemistry and molecular biochemical studies to support registration and commericialization of biotechnology products. Performed protein extraction from plant tissues, polyacrylamide gel electrophoresis, and Western blots.

Indianapolis, In, Us

Monitored the degradation or repair of DNA in vivo in e. coli utilizing standard microbiology and molecular biology techniques. Performed bacterial cell culture, SDS-PAGE, PCR. Prepared reagents and bacterial growth media and plates.

Us

Stability testing of products, USP monograph testing of raw materials, upkeep of the chemical inventory, release testing of products, environmental monitoring of a clean room, making batches of products for Research and Development, HPLC method development and validation