Mahboubeh Nazari, M.Sc.

USA • Phone: 516-***-****

advvdg@r.postjobfree.com

Summary of Qualifications:

• Over 17 years of progressive experience in pharmaceutical, food, nutraceutical, cosmetic and hospital environments

• Extensive knowledge of current good manufacturing practice (cGMP) and other Guidelines as USP, EP, FDA, USDA, CFIA, MLG, BAM, AOAC, CMMEF, Health Canada, and HACCP.

• Maintained and improved Quality Control Systems, QMS, and improve and implement the laboratory information management system LIMS following provincial regulations

• Hands-on experience on initiating Out of spec, NCR, corrective action and CAPA reports, SOP writing and revision, hands-on skilled on all microbial QC testing on pharmaceutical, cosmetic, NHP and food products, environmental monitoring (EM) testing, air and water testing, stability, and shelf-life studies and SARS-Covid testing on environmental swabs

• Reviewed the results, raw data, media, instrument, specification, method reference to release raw material, mass, finished product, OTC, and non -OTC products in LIMS

• Liaise with different internal departments, external clients, and sample receiving to coordinate distribution of samples

• Providing the client and the sale team with technical support with strong communication skills, creating and maintaining CRM to meet sale’s needs promptly and improve business relationship with existing and potential clients

• Expert in planning, organizing, and managing the effective utilization of people up to 50 direct reports, resource, and equipment

• Skilled in developing and leading high-performance teams in accordance with regulation to meet productivity goals and complete challenging projects, strong organization skills, work independently, multi-tasking, detail-oriented planer, troubleshoot the problems associated to the projects, with a team-oriented attitude and customer satisfaction focused

• Managed the department’s budget toward the company’s financial goals

• Extensive computer skills; Word, Excel, Outlook and a good understanding of data analysis and statistics

• Generated the monthly report, released the monthly invoices, and maintained the client accounts.

Proficient in English, French, Persian

Education

MSc and BSc were evaluated in the United States by The Trustforte corporation and IEE (International education evaluation)

• Master’s degree in Biochemistry, University of Payame-Noor, Tehran 2006-2008

• Bachelor’s degree in Cell & Molecular Microbiology, University of Alzahra, Tehran 1996-2001

• Hazard Analysis Critical Control Point (HACCP) and food safety course, Montreal, Oct 2014

Certification

• Water and wastewater analysis, North York College, Toronto May 2016

• Lean Six Sigma Black belt with MSI is in progress

• Corporate finance course with Udemy is in progress

WORK EXPERIENCES

Microbiology manager VitaQuest, Caldwell, NJ May 2022 up to date

Overseed the daily operations of the QC microbiology department, and ensure that raw materials, finished products and probiotic placed on test promptly to meet the client’s expectation

Participated in process improvement by 20% Improvement, reduced the department’s cost 25% by reviewing the available resources and managing the workflow

Worked closely with the Raw material group and the regulatory team to define the material specifications, required standards and the suitable method of analysis

Coordinated with production, planning and raw material departments to ensure promptly testing the raw and finished material and understand the priorities

Performed the challenge studies to define the appropriate procedure for each strain, and maximize the growth of lactobacillus strains

Implemented the new SOP to perform Listeria, Ecoli0157 and Salmonella in the lab following FDA and AOAC methods

Developed the SOPs, microbial testing procedures to meet the production and planning needs following each vendor’s requirement

Liaised between customer service, purchasing, production, product development, QA, and chemistry departments for effective communication and meet the business goals

Communicated promptly with QA and production team to notify them of OOS and placed the batch on hold, keep tracking/trending of the OOSs, and create the investigation reports to reject the batch and avoid product’s recall

Advised the management team on purchasing the new PCR equipment, tracking the preventative maintenance, calibration, and troubleshooting as needed

Worked with the production team to improve the environmental monitoring, and water testing to enhance the quality of finished product and prevent cross-contamination

Participated in developing a new LIMS system and trained the lab technicians to smooth transition from logbooks to the LIMS

Managed daily operation, sample distribution, transport, log-in, and supply chain

Conducted performance review for direct reports personnel, take disciplinary action and improvement plan as per need

Reviewed the SOPs, protocols and work instruction for gap analysis and initiate change controls as per need to ensure following the compliance FDA, AOAC and USP were met

• Ensured execution of data integrity, GMP, ISO & 21 CFR part 11

Worked closely with health and safety department to enhance the workplace safety and reduce injuries by 70%

Reviewed the logbooks, data, and prepared the staff for FDA audit

Improved the employee’s engagement, conducted the new hires interview, onboarding and training

Technical director & Microbiology manager Certified laboratories, Melville, NY Jul 2021 up to May 2022

Approved as a technical director at New York Department of Health Wadsworth Center

Conducted internal assessments and audit and provided action plans to close the gaps

Reviewed the water testing, environmental monitoring and microbial testing raw data and released the CofA

Coordinated the projects, including FDA, internal and external clients’ projects to ensure sample distributed, project initiated, and the final reports released promptly

Effectively communicated with clients, sale team, FDA officer and providing guidance, result interpretation and methodology advice as needed

Chemistry & microbiology Manager, Estee Lauder, Canada Jan 2021 to Jul 2021

• Performed a wide range of microbiological and chemical QC testing included total count, yeast &molds, lactobacillus, Pathogen confirmation (API), Growth promotion, antimicrobial efficacy, and VITEC, specific Gravity, penetration, viscosity, and troubleshooting any out of spec results

• Reviewed the results to release raw material, mass, finished product, OTC, and non -OTC products in SAP in a timely manner and support production.

• Participated in releasing the product under rush (RUR) for microbiology and chemistry

•supported the plant hygiene program by reviewing water systems, air & EM testing results and advise on corrective actions.

• Supported the planning, QA lab, production, and R&D teams by planning, implementing, and overseeing sample distribution, daily activities of microbiology and chemistry labs day/evening/ night shifts, accuracy of results and troubleshooting

• Coordinated the construction of a new microbiology and chemistry lab at Scarborough, created the change controls, and executed the IQOQPQ protocols for autoclave, incubators, and lab equipment, scheduled moving the hazardous material and equipment

Microbiology Manager, Eurofins, Toronto, Canada Jan 2018 to Dec 2020

Operation Supervisor, Microbiology, bioMerieux, Ontario, Canada 2016- Jan 2018

• Designed and established a new ISO 17025 accredited lab from scratch. The first branch of Eurofins laboratories for food testing in Canada

• Implemented a new rapid and cost-effective method of qPCR platform for pathogen microbiology testing called BACGene that reduced time, consumable material and increased

• Performed a wide range of microbiology and biology testing, included VIDAS (ELISA), BAX (PCR), qPCR, SARS-COV testing, endotoxin, particular matter, viable/non-viable EM testing

• Implemented new virus testing protocol to detect SARS-CoV in environmental swabs by running qPCR(Agilent), and increased in sale

• Communicate with customers and CFIA to inform them of food recall, the discrepancy of labelling, temperature

Supervisor QA/QC Microbiology, C-crest Laboratory (Euro-Pharm), Montreal, Canada 2014-2016

Senior Microbiology Analyst, C-crest laboratory (Euro-Pharm), Montreal, Canada 2013 -2014

Microbiology Analyst, C-crest Laboratory (Euro-Pharm), Montreal, Canada 2011-2013

• Performed environmental monitoring of working surface, personal, the air and water of facility areas, and equipment by settle plate method and swabbing following EM guidelines

• Performed microbiological and chemical analysis of raw material, in-process bulks and finished products, including pharmaceutical, NHP, cosmetic and vitamins following USP and EP methods

QA/QC Supervisor, Life medical diagnostic laboratory 2007-2011

Laboratory Supervisor, Pasteur-No Hospital diagnostic laboratory 2004-2007

• Stablished IVF in vitro fertility department in hospital

• Performed wide range of blood, urine and human fluids, hormonology, biochemistry, hematology, and preparing the pathology slides

• Carried out phlebotomy on kids and adults

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