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Raw Materials Quality Control

Hyattsville, Maryland, United States
January 03, 2018

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**** **** ***** ***

Bladensburg, MD 20710



Raw Materials Coordinator

Novavax, Inc 02/16 11/16

Responsible for setting up raw material sampling environment to carry out raw material sampling.

Sample incoming raw materials on time and in accordance with the documented procedures prior to their usage according to US and EU GMP requirements.

Enter samples in the appropriate GMP status tracking log and QC testing tracker.

Coordinates with material managements, and quality assurance to ensure that raw materials are shipped to the outside testing laboratories in a timely manner and according to the documented procedure.

Coordinates with cross-functional teams and outside testing laboratories to ensure that raw materials are released prior to their needed date.

Manage the day to day operations of raw material sampling, ensuring a timely, effective, and compliant operation is performed in support of the manufacturing operations.

Performed routine and/or special sampling of raw materials utilizing appropriate aseptic sampling techniques per standard operating procedures.

Maintained adequate inventories of sampling supplies and performed other tasks as necessary and assigned.

Quality Control Analyst 06/06-02/14

MedImmune, Inc.

Logged in and received sample using BECKMAN LIMS. Handled both powder and sometime liquid raw materials.

Performed deviation investigations and devised/implemented CAPA’s. Supported manufacturing by performing assays such as, Bioburden for water and products, Raw Material for Membrane Filtration and Pour Plate, Endotoxin, Water Analysis and Conductivity (WAC) and Biological Indicator. Performed plate read for environmental monitoring, Bioburden, Bioburden Raw material, Compressed Air and Growth Promotion plates. Performed daily and monthly calibration on all QC Micro instrument. Conducted testing in prioritized manner to ensure all deadlines were met in support of production.

Quality Control Analyst 1 08/01-12/06

Human Genome Sciences

Responsible for environmental monitoring for all facilities, other assays performed includes but not limited to: Functional Sterility, Growth Promotion, Bioburden Membrane Filtration, Bioburden Pour Plate, Compressed Gas Testing, Biological Indicators and monitoring of Bulk Fill. Support the production of Repifermin, Lymphostat B, TRM-1, TRM-2, Albugon, Albutropin, TR2J, PamAB, and sterile Media Hold. Wrote and Review, Deviations, Corrective Actions, Investigations, Quarterly Report, SOPs, Test Request, and Environmental Data Capture forms. Participated in the PQ Validation for the Clinical Production Suite and Microbial Production Facility. Participated in the commissioning and PQ of Compressed Gas Systems for Area 1 Wing B and C. Supported Change Control for CPS’ Compressed Gas Systems. Perform inventory and process purchase requisitions

Maintained Instruments and equipment Logbook for all facilities: Pilot Plant, Mammalian, Travail and CPS facilities. Trained new analysts on environmental monitoring, and assays for all facilities.

Environmental Monitoring Team Lead

Virxsys Corporation 10/00 – 06/01

Responsible for the environmental monitoring program of the class 10,000 cleanroom which consists of routine differential pressure, particulate and microbiological monitoring of processing and manufacturing operations for which cGMP regulations apply. Duties performed includes but not limited to: Taking a corrective action plan when actions levels are exceeded, routine sampling and frequently of monitoring non-viable and viable particles in the air and viable particles on surface, routine monitoring of differential pressure readings and obtaining environmental samples in accordance with the sampling locations and frequencies and submit the samples to quality control (QC) Personnel. Daily monitoring of temperatures of controlled environments, ensuring that all equipment used in environmental monitoring is calibrated on or before the due date, wrote SOPs and Raw material specifications. Trained under current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). Maintained mammalian cell lines, assisted in purification and collection of virus. Trained and assisted in plasmid purification which includes propagation of plasmid DNA in E.Coli, DNA extraction and purification using anion-exchange chromatography and Size-exclusion chromatography. Created bacterial master cell bank.

Aseptic Filling Technician / Liquid Media Formulator 12/99 –08/00

Mediatech, Inc. - cellgroâ

Responsible for the automated and semi-automated filling and packaging of sterile cell culture media and other sterile fluids in a class 100 cleanroom following current Good Manufacturing Practices (cGMP). Inspecting and testing of products and raw materials. Moisture test on powdered media.


B. S. Biology Howard University, Washington DC 1999

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