Quality Data Entry

Aneta Pekalska

**** *. ******* ******, *** *

Chicago, IL 60640

(614) 404 – 7576

*******@*****.***

EXPERIENCE

Fresenius-Kabi

Production Supervisor August 2014 – November 2014

• Responsible for assigning, instructing, and training of filling, capping, and inspection department personnel

• Continuous On-The-Floor-Supervision ensuring SOPs and GMPs are being followed, aseptic techniques are

being observed, and filling operators kept production continuously running

• Working closely with Formulation, Component Preparation, Maintenance, and Lyophilization Department to

ensure daily production goals and timelines are met

• Preparing for and attending daily operations management shift change meetings as well as creating daily

shift reports

• Reviewing and completing all production documents including disinfection records, batch records, activity

logbooks for compliance

Interim Compounding Supervisor (Nanotechnology) October 2013 – July 2014

• Responsible for the overall supervision of compounding department personnel as well interdepartmental

coordination for scheduling purposes

• Ensured adequate systems were in place to effectively manufacture bulk product in accordance with

applicable SOPs, DEA, OSHA, FDA, and cGMP regulations

• Worked closely with Maintenance, Quality, Metrology, Microbiology, and Validation to ensure environmental

area monitoring, PM, calibration and re-qualification schedules are met

• Worked with the HMI to monitor and troubleshoot equipment during bulk product processing

• Reviewed controlled batch records for compliance according to strict requirements

University of Toledo

Research Assistant January 2011 - July 2013

• Performed laboratory procedures such as culturing various bacterial colonies, water quality testing, air

quality testing, DNA extraction, PCR and DGGE analysis

• Composed progress reports for the Environmental Protection Agency

• Managed laboratory functions including organization, ordering and scheduling equipment use

• Trained fellow graduate and undergraduate students on laboratory molecular biology skills

• Interpreted and presented findings produced in the lab at various conferences

University of Charleston

Undergraduate Research April 2008 - October 2008

• Collected water samples and tested water quality

• Interpreted and analyzed data

• Researched various coal mines for comparison of its effects on streams

WV Department of Environmental Protection

Internship June 2008 - March 2009

• Inspected mine sites for safety violations May 2007 - November 2007

• Conducted stream analysis

• Surveyed environmental locations to determine remediation qualifications

• Performed water sample analysis and data entry of results

EDUCATION

University of Charleston, Charleston, WV December 2008

Bachelor of Science, Environmental Sciences

University of Toledo, Toledo, OH August 2014

Master of Science, Microbiology

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