Martha Sobolev

Responsible for generating of study plans and reports for validation and routine testing (LC/MS-MS and ELISA) Perform PK evaluations of preclinical and clinical studies using WinNonlin Prepare preclinical reports, and assist in preparation of clinical reports Review data and interact with other departments to improve the accuracy and quality of reporting Work in direct contact with clients Ensure delivery of study plans, analytical data and reports to clients in a timely and efficient manner.

Assisted in the preparation of QC reports Organized and filed QA and QC documents

Provided administrative support to related activities within the Quality Services functional areas to ensure efficient, well coordinated functions. Responsible for the overall management of SOPs and related operating documents to ensure timely issuance and maintenance of regulatory and WellSpring Pharmaceutical Canada standards. Prepared master processing, packaging, formulae, and procedures documentation for in-house products in-house and for third party production.

Performed physical/chemical analyses of raw materials and drug products. Assisted in the quality assurance area: filing, reviewing, and performing physical tests. Wrote summaries of Investigation Reports