QC Chemist

JUDITH MACKMALINE HEMA JUSTIN RAJA KUMAR

SUMMARY OF EXPERIENCE:

Currently I am working as a QC Chemist in Granules pharmaceutical, Chantilly. I worked as a Laboratory Technician for 2 years a Hospital, 2 years of Sample management Technician and QC chemist still now.

Hand on Experience:

Water content by Karl Fischer, Standardization of Karl Fischer, Dissolution by HPLC, System wash, Sample set creation,Method set creation, Instrument method creation, processing results by Empower and documentation, determine the particle size and shape by capsizer, disintegration test for drug as per SOP and Standard Test Method.

Calibration of pipette, Calibration pH, writing SOP, Purification of DNA, purification of RNA and plasmid, PCR, Gel Electrophoresis, finger printing, Aseptic technique, Identify organisms under microscope, preparation of buffers, Culture media preparation, centrifugation, Autoclave, Sterilization of glass wares, Gram stain, Identification of Positive and negative bacteria, Antibiotic sensitivity test, Serial dilution, Biochemical tests, sub culturing bacteria, detection of antigen or antibody by ELISA test, Acid Fast stain, Freezer inventory, maintaining stock, maintain records in electronically and manually, QC documentary level, Excel, word, outlook and PPT. Basic knowledge of bioinformatics.

Education:

Biotechnology Lab technician (Jan2021-present): NOVA Community college.Annandale.VA

Calibration of pipet, Calibration of pH by% of error and Standard deviation. Serial dilution, making Solution, Making buffers, Purification of DNA, purification of RNA and plasmid, casting Agarose gel and running Gel Electrophoresis, Quantitation of DNA by Spectrophotometer, protein quantitation by spectrophotometer, Purity of DNA, finger printing, Plasmid Mapping, Aseptic technique, Culture media preparation, centrifugation, Autoclave, Sterilization of glass wares, Gram stain, Identification of Positive and negative bacteria, detection of antigen or antibody by ELISA, Gel electrophoresis, detection of DNA by Nanodrop spectrophotometer, making Standard curve, separation of mixture of proteins by column chromatography, gel chromatography, Ion- exchange chromatography, protein quantitation, SDS PAGE, Western blot, PCR testing,basic Laboratory calculations.

Master’s Science in Applied Microbiology (Aug1998-Nov 2000): Vivekananda college for women, Erode, India.

Medical microbiology, Immunology, Biotechnology- Subjects

General high lights: Basic laboratory calculations, Making solutions, Media preparations, culturing bacteria, identification of pathogen, detection of Antigen Antibody and quantitation.

Bachelor’s in Botany (Jul1993-Jun1996): Holy Cross College. Nagercoil, India.

Cell Biology, Botany, Zoology, Chemistry, Biotechnology.

EXPERIENCE:

Granules pharmaceutical, Chantilly: (From Oct 2021-present): QC chemist

Water content by Karl Fischer to different drugs

Standardization of Karl Fischer

Dissolution by acid and buffer stage

Preparation of buffer, blank

Dissolution by HPLC

Mobile phase, needle wash, seal wash preparation with all HPLC SET UP

DISSOLUTION sample collection by Auto sampler and manual

Dissolution media preparation

Correlation and percent assay calculation

Maintain lab notebook and log books

Sample set creation, Method set creation, Instrument method creation in Empower3

processing results by Empower and documentation

Granules pharmaceutical, Chantilly: (From May2021-Sep2021):QC Associate Bio chemist

Stability coordinator

Inventory of stability chambers (in CRT, ACC, INT), Assigning AR Numbers and issuance number according to Protocol and as per SOP.

Initiating the product. loading the samples in different conditions.

Daily monitoring

Worked with controlled samples

Calibration of pipet error.

Maintain Laboratory Notebook

Smithers Bioanalytical Services, PDS Gaithersburg, MD (Sep 2019 – Nov 2020)

Laboratory Technician

Receive, check-in and dispose of study samples according to established guidelines and SOPs in a timely fashion.

Monitor proper storage of samples, including appropriate location, temperature, and condition.

Manage multiple studies. Able to produce high quality data while working under the pressure of strict deadlines.

Prepare sample labels using automated and manual systems.

Work with LIMS Watson.

Notify PI/PM and sponsor of sample quality issues and documents appropriately.

Ability to function effectively in a team-oriented atmosphere. Works independently when necessary.

Notify PI/PM and sponsor of sample quality issues and documents appropriately.

Performs general sample management laboratory support functions such as supply inventory, shipping procedures, lab equipment (freezer) maintenance.

Other duties as assigned and trained.

Performs end of day/Freezer closeout tasks

Ability to function effectively in a team-oriented atmosphere. Works independently when necessary.

Verifies transfer requests, create run boxes/stage runs and re-file analyzed samples to permanent location

On-Call for REES Freezer Monitoring.

Complete QC documentary level according to SOP.

Ability to function effectively in a team-oriented atmosphere. Works independently when necessary.

Participating daily huddle.

Iruthayam Hospital, India, (Feb2013-May2015)

Microbiologist

Prepare Data for the allocated tests.

Detection of antigen or Antibody by ELISA Method.

Gram stain and identify bacteria through microscope.

Acid-fast stain and identify Acid Fast bacilli through microscopic slide.

Separate serum and plasma by Centrifuge.

Autoclave for media preparation and sterilization.

Performed registration, Inoculation, Isolation, Biochemical testing, Identification and Antimicrobial susceptibility testing procedures and techniques.

Maintain the samples and media in refrigerators, Hepa filters and incubator

Culture and identify the pathogens from various samples (blood, urine, Pus and sputum) by various biochemical reactions.

Environmental monitoring

Prepare chart about the report sent it to supervisor.

Good Knowledge about Autoclave, Liquid and Solid Culture media preparations, checking the PH through PH meter or paper, Reagent preparations, fumigation, and sterilization.

Prepare culture media for fungus.

Culture and identify the fungus from various media.

Find out antifungal agents.

Contact this candidate