Quality Control Assurance

Gagan Kaur Address:

Email: *********@*****.*** **5 Rockywalk Ct.

Phone No: 919-***-**** Durham, NC 27713

OBJECTIVE:

Seeking a Quality Control/ Quality Assurance position in a people oriented

organization with opportunity for growth and development.

Strengths:

• Knowledgeable in a broad range of scientific disciplines including but not limited

to Cell culture, Aseptic techniques, Virus Titration (TCID50), Clinical and

Commercial Viral testing InVitro Adventitious Virus Assay, Hemadsorption,

Hemagglutination Assay, QPCR, Assay validation, Plant molecular biology,

DNA, RNA and Protein isolation, Media prep, SDS-Page, authoring, reviewing

and revising controlled documents, validation protocols and reports, Drug

development process, Clinical trial process, Trackwise, FDA regulations, ICH

guidelines GMP, GLP, GCP, EHS&S compliance, LIMS.

• Performance of daily GMP testing following USP, EP and FCC methodologies.

• Robust and compliant cGMP documentation practices.

• Proficient in ATLAS, e-Docs to author, revise and review controlled documents.

EMPLOYMENT HISTORY:

Biogen Idec September 2011 – March 2013

Associate I, Quality Control

• Execution of routine QC testing and all activities associated with testing of

clinical and commercial products in a Viral detection laboratory.

• Executing robust and compliant cGMP documentation practices under

FDA/EMEA regulations.

• Analytical/technical support and problem solving during routine testing and

figuring out ways to improvise testing timelines.

• Data collection and compilation for review and performed final review of data to

support routine QC testing.

• Ensure overall project efficiency and adherence to project timelines.

• Report performance metrics and out of scope activities while keeping constant

communication with management.

• Authoring CAPA’s, deviations.

• Proficient in running In Vitro adventitious Virus assay starting from Day 0 to the

final reads after hemadsorption on Day 28. Performed all aspects of the assay

from cell counting, seeding of assay flasks (MDCK, CHO- K1, VERO, MRC,A9)

re-feed, TA prep and inoculation, Day 14 passaging activities, Examine cell

cultures for CPE and Hemadsorption and compiling the results.

• Responsible for all Media prep (Growth, Negative, TA and Positive), supplement

prep for continuous and smooth flow of assay operations.

• Trained in monthly PM’s on equipment, managing the KanBan inventory system.

• Supporting the virology team in execution of transfer, qualification, improvement

projects, and validation of analytical methods.

• Document management and archival in collaboration with QA.

• Trained on DAS/TIPS equipment monitoring system and understanding the step

by step process in case of systems failure.

• Procurement for the Virology team with excellent supply chain management with

no interruptions in clinical testing.

• Inspection readiness. Successful FDA inspections and third party audits.

• Corodinate/support QC Virology activities and completed deliverables on time

without fail.

• Supported project plans to bring Global QC Virology support to operation of

Hillerod team.

• Virology team lead for Carolina star program. Helped Biogen achieve a Carolina

Star award through Department of Labor making Biogen a leader in a better and

safe place to work

Novartis Vaccines and Diagnostics, Inc.

QC Virology/PCR Analyst November 2010 – September 2011

• Maintain and propagate Madin-Darby canine Kidney (MDCK) and AV3 (Human

amnion epithelial)mammalian cell cultures and African green monkey kidney

cells (VERO).

• Culture Master and Working cell banks.

• Perform the Hemagglutination assay for the identification and semi-quantitative

analysis of Influenza A and B virus hemaglutinin in engineering run samples.

• Determined the number of infectious influenza virus particles in samples with the

Influenza Virus Titration Assay. (TCID50)

• Performed Hemagglutination and TCID50 assay validation.

• Performed RTD-qPCR for detection and quantification of Influenza virus A and B

in ER samples.

• Proficient in using ATLAS to write, revise and review controlled documents,

validation protocols and reports including but not limited to SOP, SRA, SCF’s and

URS.

• Authoring CAPA’s, deviations, laboratory exceptions and Investigations.

• Sample Aliquoting, distribution, storage and result entry and analysis through

LIMS.

• Installed Lab Equipment and working on the documentation to assist in proper

installation.

• Work on Maximo to keep preventative maintenance of lab equipment up to date.

• Extraction and purification of Nucleic acids using Roche Magnapure and runnig

the ER and TD samples on QIAgility in support of PCR runs.

• Running and analyzing the results for the ER and TD samples on Rotor Gene real

time PCR Thermocycler.

• Analyzed and interpreted data for troubleshooting.

• Manage and support lab operations to be in compliance with cGMP requirements

such as following the lab safety and health policies, accurate documentation,

keeping lab books up to date, lab equipment maintenance and calibration, etc.

• Mentoring interns and new employees.

NCCU

Lab Assistant August 2008 – December 2010

• Running SDS-PAGE for protein identification and differentiation between green

and variegated plant species.

• Plant tissue culture and propagation.

• Proficient in seeding, transplanting, transfecting and harvesting of plants.

• Protein purification and detection by affinity chromatography.

• Worked on Gene cloning techniques such as DNA digestion, DNA ligation,

transformation, transgene selection and running colony PCR to analyze and

visualize results.

• Performed Genome walking to clone a full length genomic sequence of a gene by

designing gene specific primers, determining intron-exon junctions, sequence

search and analysis using NCBI tools like Blast and Clustalw to obtain upstream

and downstream sequences of the regions flanking cDNA.

• DNA and RNA isolation, Miniprep, Chlorophyll and Total protein extraction

following protocols with nucleotide concentration and chlorophyll measurement

using Nanojob and Spectrophotometer.

• Bacteria culture and maintenance in aseptic conditions to harvest and store

bacterial cells.

• Performed qRTPCR and Colony PCR for plant samples.

• Managing, analyzing and compiling data using Microsoft office tools.

• Research databases, and navigate NCBI to reach desired goals. Efficient in DNA

and protein sequence analysis and alignment.

• Follow SOPs, comply with GLP and cGMP.

Research Experience

• Project I: Comparing and analyzing green and yellow tissue in five different variegated plant species

in terms of Chlorophyll, DNA, RNA and Total protein and also characterization and mapping of

proteins found solely in either green or yellow tissue via Mass spectrometry.

• Project II: To find the unknown upstream and downstream sequence of a Golden pothos gene

flanking the known cDNA sequence and clone the full length genomic sequence of this gene via

genome walking process.

EDUCATION:

North Carolina Central University

Degree: Masters in Pharmaceutical Sciences

GPA: 4.0

6 Credit hours remaining.

Punjab University

Degree: Bachelors in Business Administration

Major: Human Resource Management

GPA: 3.8

Graduated: July 2003

Other Strengths

• Dynamic team player with “We can do it” attitude. Known to take new challenges,

volunteer to take on new issues and dive in to learn about new situation and

possibilities.

• Confident and aggressive decision making skills understanding mission critical

priorities.

• Flexible, adaptable and will shift gears based on the team needs.

• Demonstrate accountability at all levels and able to multi task and coordinate

multiple activities in parallel in a fast paced environment.

• Excellent organizational and planning skills with ability to utilize problem-solving

techniques applicable to constantly changing environment.

• Ability to work independently with or without supervision and seek guidance

when necessary.

• Great interpersonal, verbal, and written communication skills along with outstanding

presentation abilities.

• Effective time management in order to meet daily metrics, team objectives and

department goals

• Technically skilled in learning and adapting to internal softwares.

Certifications:

• Lean lab certified.

• Certification in Elements of Current Good Manufacturing Practices in

Biomanufacturing Processes.

Contact this candidate