Post Job Free

Resume

Sign in

Quality Control Research Associate

Location:
San Diego, CA
Posted:
December 27, 2023

Contact this candidate

Resume:

Anita Ridin Bosco Silvester

Contact: ad19bo@r.postjobfree.com

Mobile: 858-***-****

Summary:

Enthusiastic and driven Analytical Chemist with over 6 years of practical laboratory experience in analytical skills and wet lab experiments. Proven expertise in trouble shooting, with a strong focus on accurate data interpretation and adherence to regulatory standards. Adept at developing optimized analytical methods resulting in improved efficiency and reduced analysis time. Highly organized with excellent communication skills, ensuring effective collaboration within cross-functional teams. Committed to scientific excellence and passionate about making a positive impact in the field of analytical chemistry.

Skills:

Softmax Pro - ELISA

Agilant Aria – PCR

Size exclusion chromatography.

Western Blot

SDS- PAGE

Growing Chok -1 RBD Covid – 19 cells

Cell Culture

Antibodies

CAPA, Risk assessment

Education

M.S Chemistry - University of Bharathidasan, India.

Internship Projects:

Nickel Electroplating

Post graduate project about the complete process in Saponification of Detergents – Hindustan Lever Limited

Experience

CTK Biotech June 2017 – April 2021

Research Associate

Responsible for planning, conducting, and summarizing all aspects of the research including creating primary data resources and identifying secondary data sources.

Creates and manages data, performs statistical analyses, and writes research reports and maintains clear lab notebook.

Continues to be Safety Officer of the IVD department.

Quality Control:

Stays current on applicable regulation and guidance from FDA, ISO13485, CLIA, CAP, etc

Performed numerous quality control jobs related to the product submission to meet cGMP.

Molecular Biology Techniques:

Confidently handle molecular biology techniques to clone target genes into in-house expression vectors.

Supporting Test Method validation and Transfer from internal or external labs

Trained over Covid – 19 PCR tests with the Qiagen PCR kit.

Carried out Gibson Cloning, transformation, Inoculation and Plasmid extraction.

Performed Peptide Analysis - Epitope Mapping Array

DNA - Gel Electrophoresis

Immunization Project – Immunizing Rabbits, goats and lama with Dengue (4 serotypes), HIV, Covid -19 Immunogens and finding the titre through cell-based assay techniques.

ELISA:

Responsible to produce ELISA kits.

Performed multiple validation projects for the ELISA Products.

Worked in Design control of the ELISA products.

Production transfer of Vitamin D kit.

Cell Culture:

Maintaining Cell lines – Hek T, Chok- 1, ExpiCho, Expi – Hek for the transfection process.

Performing Protein purification after harvesting.

Dot Blot Assay to Screen the good Clones.

PBMC (peripheral blood mononuclear cell) Extraction.

Performed Pull- down assay to find any Protein – protein interaction.

Growing Chok -1 RBD Covid – 19 cells, have a plan to use them in bioreactor once they are ready with expected expression.

Antibodies:

Purify Antibodies with protein A beads and nickel beads through affinity chromatography.

Determination of Protein Purity by SDS- PAGE.

Western Blot

SEC – Size exclusion chromatography.

Lateral Flow Assays:

Manufacturing Rapid test kits.

Manufactured lyophilized Positive controls and trouble shot issues with lyophilization process.

Performed double blinded study for the Dengue rapid test kit.

Carried out different stability studies to enhance the stability of the positive control of the rapid test kit.

Sekisui Diagnostics

QC Analyst I April 2021- April-2022

Conducted knowledge sharing sessions for peers

Performed Quality Control tests for the intermediate, finished rapid test kits for products like Strep A, Flu, Trichomonas, Mono, SARS COVID 19, Flu SARS Combo

Carried out Stability tests for the products to determine the shelf life of the products.

Revised Documents like Validation Protocols, SOPs, WI and forms.

Raised deviation for pipettes, intermediate products and CAPA if needed

Following 5S and LEAN Manufacturing principles in the lab and the procedure

Experience with AIAG Control Plan, APQP, PPQ, DMAIC, SPC and FMEA.

Handled Complaints and related troubleshooting processes

Ajinomoto Bio-pharma April 2022- Current

Sr. Analytical Technologies Associate

Concentration determination with different analytical methods like SoloVPE, ELISA, cell-based assays.

Closing CAPAs and dealing with deviations.

Worked on Change control.

Execution of experiments and presenting the data to the clients in a timely manner.

Carrying out risk assessment for various instruments and methods.

On-Going Certifications:

CQE @ ASQ.



Contact this candidate