Quality Data

Apexa Patel

*** ******* ***,

South Plainfield, NJ 07080

908-***-**** · ********@*******.***

OBJECTIVE

Dedicated self-motivated Quality Control specialist with more than 8+ years’ experience and a proven ability to successfully maintain control of Quality processes assuring product quality and compliance with high productivity, enabling effective leadership in a diverse environment. An experienced strategic thinker with strong problem solving skills and communication skills.

PROFESSIONAL EXPERIENCE

Immucor/ BioArray Solutions Warren, NJ

Quality Control Technologist II Nov. 2019 – Present

•Quality Control testing utilizing established standard operating procedures and product quality specifications in accordance to established safety guidelines and procedures, and as specified by appropriate internal and external regulatory agencies such as FDA.

•Hands on experience with Maintained and updated Batch Manufacturing Records, Quality documents including process master documentation, product specification, change control, qualification and validation documents according to Good Documentation Practice (GDP).

•Use of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

•Assisted Audit Manager in customer and internal Audits and Inspection according to ISO standards and managed quality processes, procedures and performed review and approval of documentation.

•Review of raw materials testing according to required compendia and SOPs.

•Responsible for Maintenance & Troubleshooting equipment in QC, Handling of Non-Conformance Material Report (NCMR), Customer Complaints, and Corrective & Preventive Actions (CAPAs), Deviations, Root Cause analysis, Change Control, Out of Specification (OOS) and Investigation.

•Manage various product stability program such as real time stability with greater than 98% time points scheduled accurately. Test and review of Stability Protocols and data.

•Executed various immune assays including HEA, HPA, RHCE, RHD and HEAx MLR testing, IPCT testing, Threshold testing, and other product quality control testing, in-process and final product release test.

•Analyze experimental data using approved data analysis software; assumes responsibility for timely and accurate document completion.

•Hands on experience with NGS (next gen sequencing) product with Illumina MiSeq automated sequencer and retrieving data and created reports.

•Expertise in automated and manual whole blood genomic DNA extraction by utilizing QIAgen QIAcube, Stratech magnetic bead automated DNA extractor by utilizing QIAgen and Stratech reagent kits.

•Isolated RBC solution by centrifugation to extract DNA and run PCR amplification on various assay method to get Phenotype and Genotype data and generate repot based on the data.

•Capable and expert utilizing various laboratory equipment such as ABI Veriti PCR Cycler, UV Imaging, Nanodrop 1000/2000, Boekel Oven, Osmometer and Florescent Microscope, MiSeq Auto Sequencer, QIAgility auto liquid pippetor etc.

•Extended knowledge in automated and manual procedure for extracting whole blood and Leukoreduced blood samples.

•Contact Outside vendors for scheduling to perform Preventive and maintenance on Lab Equipment.

Immucor/ BioArray Solutions Warren, NJ

Quality Control Specialist I Aug. 2018 – Nov. 2019

•Expertise’s in Gel Electrophoresis, reconstituting primer and probes, measuring DNA and probe concentration, various liquid contact angle measurement, and worked with nanostrip (Piranha solution to clean glass slide)

•Performs incoming raw material inspection and testing of product according to approved Standard Operating Procedures(SOP’s)

•Responsible for laboratory maintenance, for lab safety, and regulatory compliance, as well as applying 5S to laboratory environments to increase efficiency and minimize waste.

•Assists in aggregating and assessing data for Nonconformance evaluations.

•Identifies initiates, facilitates, participates and implements process improvements to meet business needs.

Immucor / BioArray Solutions Warren, NJ

Manufacture Associate March 2014 – Aug 2018

•Worked between Manufacturing/Packaging Operations and quality Compliance to ensure Manufacturing policies and procedures are in accordance with the cGMP requirements.

•Document errors found during the review process and assure adequate corrections are documented.

•Ensure and practice GDP & GMP in manufacturing BeadChip carrier and reagent assembly to meet highest quality FDA approved products.

•Have full knowledge of manual and semi-automated equipment in manufacturing facility.

•Work with and have full knowledge of instruments such as Dynatex, ESEC, CamaLot, Plasma-Preen, AIS Microscope, pH meter, Osmometer, Handy Step and multi-channel pipettes.

•Work with incoming material such as Silicon Wafer to check its quality and Nano strip Cleaning for BeadChip Assembly.

•Worked with Quickcheck software for decoding and clustering of HEA1.2 (RUO,CE & Precise type), HPA, RHCE, RHD, and HEAx Products.

•Prepare various reagent and buffers by following approved protocols.

•Trained New employees in various methodologies and work practice to ensure best manufacturing process are met.

•Collected and disposed organic and in-organic waste from laboratory in specified container and at specific area.

VSA Accessories Piscataway, NJ

Quality control Inspector Dec. 2013 – March. 2014

•Inspected each document and product according to company’s specification criteria.

•Trending and maintain all quality data on daily basis to track various different types of product.

•Ensure that customer receive the finest quality product that they requested.

•Perform calculation of credit adjustment & forward adjustment accordingly.

•Monitor & coordinate invoicing & shipping function for quality records.

•Respond to pricing inquiries, providing accurate & timely information.

•Became a mediator between company & customer so they receive the best quality product from the company.

Direct Mail Depot Piscataway, NJ

Quality Control Associate Dec. 2012 – Dec. 2013

•Regularly adjusted product inventory calculation.

•Document results in established controlled documents with Good Documentation Practices (GDP).

•Double check various product inventory statement for accuracy.

•Update and maintain clear product record using MS Excel, Word & Power point.

•Accurately log daily production manufacturing data, and keep track of various product manufacturing.

•Responsible for implementation of LEAN Daily Management for department and individual groups.

Accurate Diagnostic Centre Gujarat, India

Lab Technician May 2012 – Oct. 2012

•Analyzed the sample by Technique such as PCR, DNA extraction, genotyping, DNA sequencing.

•Preparing and Purifying DNA samples.

•Interpreting sequencing data using computer based approaches.

•Developing protocols and updating database.

Desai Clinical Laboratory Gujarat, India

Lab Technician (Diagnosis Test) June. 2011 – Dec. 2013

•Prepared slides from the collected blood, urine and, other body fluid samples.

•Also performed antibiotic susceptibility test of pathogen.

•Prepared smears and stained the bacterial cells by using gram staining procedure.

•Prepared media and broth for use in pathogen testing as required.

Bhanumati Clinical Laboratory Gujarat, India

Lab Assistance (Internship) Dec. 2010 – June 2011

•Experience in Registration and Collection of Patient’s Sample.

•Worked with various aspects of Laboratory Medicine such as Hematology, Clinical chemistry, Microbiology & Immunology, Surgical pathology & Cytopathology department.

•Operated fully automated hematology cell counter, semi-automated clinical chemistry analyzers, Semi-automated Dry Chemistry Analyzer, Coagulometer.

RELEVANT LABORATORY SKILLS

Automated and manual DNA and plasmid extraction method, Automated and manual Sample Preparation and isolation, Amplification and Detection, Direct Amplification, Real-Time PCR, DNA analysis, sample collection, serological testing of suspect stains for biological fluids, Transformation of Bacterial Cells. Performed Gel electrophoresis, Southern blot, and Northern blot, Western blot / SDS-PAGE Gels. Isolation of microorganism, Sterilization, Media & Reagent Preparation, Maintenance & Preservation of culture, Standard Plate Count techniques. Know aseptic techniques, Good Clinical Practice, and Good Laboratory Practice

SOFTWARE

MS Word, MS Excel, MS Power Point, Basic understanding of T-SQL, Power BI, HTML, CSS.

EDUCATION

Veer Narmad South Gujarat University, India May 2010

B.S. Microbiology, (GPA – 3.35/4.0)

M.S. Microbiology, Minor: Chemistry, May 2012

(GPA-3.36/4.0)

RELEVANT COURSEWORK

Genetics, Molecular Biology, Biotechnology and Advanced Molecular Biology, Cell Biology, Biochemistry, Advances in Recombinant DNA Technology, Immunology and Immunotechnology, taxonomy, Virology and Cytology, Applied Environmental Microbiology.

CERTIFICATION/ TRAINING

Medical Laboratory Technician’s Course in 2011

OTHER ACTIVITIES

Participated in poster presentations at various national level competitions and achieved meritorious positions.

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