Quality Assurance Resume

SUMMARY

Over 15 years experience in Quality Assurance experience with vaccines, clinical, and commercial pharmaceutical products and clinical trials work.
Over 15 years experience as a QA Compliance Specialist / Investigator.
Have experience regarding all aspects of the investigation process. Specifically, have experience observing deviations, initiating investigations, determining root cause, determining and assigning CAPAs (corrective actions/preventive actions), determining product impact, and trending both investigations and CAPAs.
Have experience performing QA review of the batch records associated to cleaning, granulation, compression, and packaging.
Experienced with both paper batch records and Manufacturing Execution Systems (MES) electronic batch records.
Knowledgable with Laboratory Information Systems (LIMS), Systems Applications and Products (SAP), and TrackWise investigation database.

PROFESSIONAL EXPERIENCE

Confidential

Quality Assurance

Responsibilities:

Responsible for the Quality Assurance review of cleaning records, granulation, compression, and packaging batch records for Imodium (treatment for diarrhea) and Pepcid (treatment for heartburn).
Determined the Product Disposition / Usage Decision (UD) for the batches to indicate whether or not they are approved for packaging and shipment.
Utilized the SAP (Systems, Applications, and Products) computer program to record these dispositions of the commercial bathes.
Performed line clearances and retain inspections to ensure product quality during the manufacturing process.
Responsible for coordinating the performance of the batch record review and the performance of the investigation so that they can be released for shipment in an efficient and timely manner.

Confidential

QA Analyst

Responsibilities:

Responsible for performing investigations about atypical events that occurred during the processing of products Remicade and Fedbatch at the aseptic Confidential and Confidential facility. Remicade is the name of the commercial product that is the cure for the autoimmune disease Rheumatoid Arthritis (RA). Fedbatch is the in - house name for the clinical product being developed that is the analgesic (painkiller) which has the positive characteristic of being non-addictive.
Determined the root causes of these investigations which included personnel, equipment, procedure, environment, and utilities.
Received input from involved parties to determine the most effective corrective and preventive actions pertaining to these events.
Determined the product impact for the materials and finished products associated to these investigations.

Confidential

QA Compliance Investigator

Responsibilities:

Responsible for conducting investigations regarding deviations that may impact commercial product quality.
Responsible for determining the root cause and the CAPA of the deviation.
Responsible for functioning as a mediator between multiple departments to acquire relevant data and to determine corrective action/preventive action CAPA owners and CAPA due dates.
Performed investigations related to both Small Volume Parenteral (SVP) and Large Volume Parenteral (LVP) Propofol, which is an intravenously delivered anesthetic.
Performed scheduled internal audits and/or mock audits to confirm that cGMP (current Good Manufacturing Practices) are consistently being performed at the site.