carol szlachta

About

Pharmaceutical professional with 23 plus years at Teva Pharmaceuticals: * Regulatory Affairs department secretary-6 yrs- SOP compliance, New Drug Applications, and ANDA mailings to FDA * Executive Secretary VP Regulatory Affairs -1 year - * Administrative Secretary for Clinical Affairs -1 year * Documentation Reviewer including learning SOPs, GMPs to know what to look for in a batch record to make sure work was completed according to protocol. * Proofreader for accurate review of Product Batch Records from each area in Manufacturing * Knowledge of Oracle computer system for entries and reconciliations that product was completed and ready for next step * Document Control - SOPs and distribution to areas that needed to train on updates. * Knowledge of Trackwise entries and expertise to look up and find past results for other departments when needed. Pharmaceutical experience as Pharmacy Department technician/secretary for 10 years at Quakertown Community Hospital, Quakertown, PA.

Country

united states

City

quakertown

Industry

pharmaceuticals

Skill

pharmaceutical industry, sop, cgmp practices, manufacturing operations, quality assurance, quality auditing, calibration, trackwise, computer proficiency, computers, computer maintenance, gmp, continuous improvement, oracle discoverer, oracle reports, excel charts and graphs, batch records, training delivery, capa, compliance, multi tasking capabilities, pharmaceutics, laboratory, change control, 21 cfr part 11, gxp, clinical research, validation, glp, document management, regulatory submissions, regulatory requirements, database administration, lims, protocol, document review, pharmaceutical manufacturing, gcp, computer system validation, ctms, cro, edc, documentum, clinical data management, ich gcp, pharmacovigilance, oracle clinical, quality control, clinical trials

Experience

pharmacy technician and department secretary

quakertown community hospital

1979-9 - 1989-9 · 10 yrs 1 mo

* Filled and ordered drugs for patients * Made Intravenous solutions when needed * Kept Department books up-to-date with frequent billing of physicians who needed pharmaceutical product for their offices * Pharmacy and Therapeutics Committee -monthly recording of minutes to meetings

senior administrative assistant

teva pharmaceuticals

2008-5 - 2013-6 · 5 yrs 2 mos

* Assisted Department Manager and Manufacturing Departments with all paperwork for the Manufacturing process. * Functioned as the go-to person for office work and equipment service calls. * Interacted with all areas and kept logbooks up-to-date. * Distributed new department logbooks and archived the old ones according to Good Manufacturing Practices * Worked on Final Output Analysis charts in Excel of daily numbers completed in each department, Requirement vs. Daily output. * Worked with SOPs to make sure all were reviewed and kept up-to-date. * Ability to enter different databases, Trackwise, Oracle, AS400 to get information when needed. Oracle lot reconciliations to end product so QA Department could review and send on to the next department. * Training and Development whenever needed.

Education

desales university

business administration

1994-1 - 1997-1 · 3 yrs 1 mo

Attended classes to learn about computers and computer software. 1985-87","Did two year Medical Transcription course -online- received Diploma --1995-1997","DeSales University-Business Administration","Continuous Improvement to update computer knowledge with class attendance when needed."]