FAREEHA A. GONDAL

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Martinsburg, WV 25403 571-***-**** (M) ad2pno@r.postjobfree.com US Citizen OBJECTIVE:

Experienced, reliable, well-organized, multi task QC/QA Lab Analyst and Analytical Scientist seeking position in Biomedical, BioPharma, Genetics and Manufacturing Laboratories. EDUCATION:

May 2003, Salisbury University, MD, Bachelor of Science in Biological Sciences with Chemistry minor

PROFESSIONAL SKILLS:

Experienced Quality Control and Quality Assurance Bio-analytical Scientific skills in Bio-pharma, agricultural bovine, medical cannabis, in vivo and in vitro biomedical industries, Highly experienced in analytical and biomedical cGMP and GLP testing instruments like Flow Cytometer, Mettler TGA, Metrohem NIR, PCR, Cell Culture, Microbiological techniques and HPLC, Fine motor skills in conducting research, editing and creating technical data summaries, SOPs and data evaluation in excel or any instrument software, Strong verbal and written communications skills including time management, mentoring, hiring and supervising lab management personnel. Proficient in developing and testing Validation of methods, protocols, reports and bioanalytical instruments, Working knowledge of quality systems, FDA regulations and regulatory systems, Experience in conducting investigations, writing deviations, implementing CAPA and initiating change controls, Experience and comfortable handling human biological material specimen samples ( BSL 1 & 2) including pharmaceutical raw materials, Excellent and intermediate knowledge of Microsoft words, power point, One drive, Google Docs, computer skills, Flexible and adaptable in fast paced and dynamic environment. Excellent knowledge and mastery skills of the methods of biochemical analysis and basic lab techniques such as PH meters, pipetting, centrifugation, Balances, TLC Chromatography, Spectrophotometer, Titrations, Western Blot, Cell Culture slides and reagents and Aseptic technique. WORK EXPERIENCE:

R&D Scientist (Chemist). Clorox ( Cat Litter) March 2023–August 2023

● Set up and validated a new test method for cat litter production on NIR and TGA.

● Processed (Milled) a variety of samples ( WIP, RollMill, Fines and Finished product) of cat litter, specifically powders to be analyzed on NIR and TGA for carbon, limestone and clay testing.

● Built a suitable model for the quantitative analytes at low concentration, specifically activated carbon at levels below 2%.

● Trained and validated on Bulk Density, Moisture, PSD and clump test including splitting samples on different splitters in QA lab.

Sr. Lead Laboratory Analyst, Columbia Care LLC November 2021–Sept 2022.

● Designed and produced processes of extraction and post extraction of medical cannabis production, including different strains of plant washing with ethanol, extraction of crude oil through Heidolphs rotovaps and then turned into purified and refined oil or honey consistency distillate through BR short path distillation.

● Transferred distillate into vapes, disposable and dablicators via Filamatic vape machine and help the final product to be packed into individual boxes at the labeling and packaging department.

● Maintained plant IDs at different stages of production into METRC and Biotrack systems and organized them for 3rd party testing and followed COAs.

● Managed lab personnel, lab related issues and inventories via indirect ordering by facility manager.

Biologics Material Scientist I, Astra Zeneca, FMC MS&T May 2021 August 2021

● Planned, Executed and Implemented changes in Second Sourcing Filters Study project for Downstream Filtration and Cell Culture Protocols with non routine test samples for drug development.

● Studies with different Vendors were conducted on PendoTEch NFSS Filtration system and Vicell with several start-up runs and improvised the system.

● Designed and Processed Vmax data and graph including summaries in excel sheets and presented to Stakeholders via PowerPoint presentation.

● Maintained Prototypes and Filters inventories in the designated system .

● Completed Astra Zeneca basic training in a timely manner. Bovine Semen Lab Manager, Trans Ova Genetics. July 2014 Sept 2020.

● Managed bovine cattle semen lab different production activities on daily basis including receiving, pulling bull semen inventory in Ova drive software, making schedule for IVF and semen labs for fertilization, prepping semen sample and run sample on Dako MoFlo cytometers to female sperms bearing X chromosomes.

● Proactive in team management meetings, complete daily and weekly projects via email communication and official reports, resolve production issues for customers and clients

(internal and external) both in a timely manner.

● Trained employees, maintained their training records, assigned new goals and followed company goals.

● Performed daily machine calibration, troubleshooting and followed strict guidelines of quality control of semen.

● Gained detailed knowledge of bovine IVF as an Embryologist. Medical Technologist II - Virology Department, Quest Diagnostics. Dec 2012 Jan 2014.

● Performed highly complex Molecular Amplified DNA/RNA Assay test on BD Probe Tec Qx and ET Viper system and Tigris using SDA and TMA technology to detect CT/GC/TV in patient samples in accordance with the laboratory’s procedure manual and protocol

● Executed monthly PM/FV Environmental Monitoring Test (Swipe test) on BD Vipers instrument including QC diagnostics.

● Performed pipetting and transferring of microbial and viral samples under BSL-2 hood, sorted and work sheeted Viper CT/GC patient samples with additional Herpes Cultures, Tigris

(gen-probe) and TSI samples.

● Executed troubleshooting and validation of instrument, new reagents and Sera Care external controls according to SOPs and laboratory’s protocols. Quality Assurance/Analytical Scientist II, Chantilly Bio-Pharma. LLC. March 2012—Oct 2012

● Executed, edited and implemented SOPs for QA, cGMP and Analytical Pharmaceutical lab.

● Experienced in Viscometer, Scott Volumeter Bulk Density, Particle Size Analyzer

(Malvern Mastersizer 2000), Nicolet FT-IR Spectrophotometer, Distek Dissolution, Polarimeter and UV-Vis spectrophotometer, TLC, Karl Fisher titration( DL-50 Autotitrator) and HPLC instruments for Raw Materials, In-process and Finished tablets.

● Prepared Standard and Test Solutions, Mobile for HPLC, GC as per USP/NF chapters, analyzing calculations from chromatograms and putting in an excel spreadsheet and documenting in lab notebook and log books.

● Sampled raw materials (Active and Excipient) under HIPPA sample hood with proper sampling

● procedure.

● Experienced in wet chemistry testing like, Arsenic Test, Heavy Metals, Lead test, Extraction, Loss on Ignition, Residue on Ignition, Identification tests, Prepared test solutions and Volumetric solutions, standardizing volumetric solutions.

● Placed orders through PO and maintained chemicals, solvents and acids inventory up-to-date. Quality Assurance/ Control Sr. Laboratory Analyst, Thermo Fisher Scientific Diagnostic and Manufacturing Company. September 2006—March 2012

● Executed and analyzed laboratory tests and procedures associated with raw material (patient plasma samples), bulk compound/ formulation, intermediate and finished goods that are used in the in vitro diagnostics, treatment and prevention of diseases.

● Proficient on Abbott Architects I2000 & I2000SR (Immunoassay Analyzer) and Siemens Advia 1650 instruments (Chemistry Analyzer).

● Worked with Production Planning group and Manufacturing team to meet production deadlines.

● Evaluated data and prepared technical summaries and facilitated complaint investigations, value assignments. Assessed Stability and also supported Advanced Manufacturing and other Technical Services groups

● Collaborated with Senior Scientists on investigational studies, trials, and troubleshooting and worked with the Complaint Investigation Department.

● Evaluated quality control within the laboratory using standard lab test and measurement controls, and maintained compliance with ISO9001, CLIA, OSHA, GLP & GMP safety and risk management guidelines.

● Drafted and revised SOPs, test methods, general specification through change orders and prepared and validated 10 excel spreadsheets, reducing the time for data analysis by approximately 50%.

● Proficient in calibration of specific laboratory equipment and troubleshooting and resolving instrument problems and in-house audit and Technical Department.

● Trained laboratory personnel on lab procedures and operations of instruments/equipment.

● Proficient in software’s SAP, QI Analyst, LIMS, SPC charting and PRMS

● Uncommon knowledge of the methods of biochemical analysis and basic lab techniques such as PH meters, pipetting, centrifugation, Balances, TLC Chromatography, Spectrophotometer, Titrations, Western Blot, Cell Culture slides and reagents and Aseptic technique.

Nationally Certified Pharmacy Technician, Rite Aid Pharmacy and Inova Mt. Vernon Hospital VA and MD, October 1999 – August 2006.

CERTIFICATION AND TRAINING:

CPR and First Aid Certification, 2006, Middletown, VA Practical Process Improvement- 2008

National Certification (PTCB) Pharmacy Technician Certification Board 1999- 2010 CPR Heart saver AED course through American Heart Association at TransOva Genetics, MD, 8/2016.

LEAD training via TOG lectures and courses March 2020.

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