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Leyli Saadat

Quality Control Analyst III

Food Science and Nutrition, BSc with Honor

Applied Chemistry, BSc

Cell: 669-***-****

Email: adrmnz@r.postjobfree.com

OVERVIEW

• Quality control (QC) analyst

• Very motivated, self initiated, problem solver, team player with time management and leadership skills

• Work experience in pharmaceutical and food industries

• Extensive lab experience and hands-on working for equipment calibration, lab procedures, measurements, documentations, troubleshoot …

• Extensive knowledge of SOP and GMP requirements

• Experience in statistical analysis of lab data using Excel and SAS

• Two bachelor’s degrees in applied chemistry and Food Science and Nutrition

• Experience with Microsoft Office including Excel, Word, and PowerPoint EDUCATION

• Food Science and Nutrition, BSc with Honor, Department of Chemistry, Carleton University, Ottawa, Canada.

• Applied Chemistry, BSc, Azad University, Tehran Central Branch, Tehran, Iran. WORK EXPERIENCE

Aug. 2020–Pres. Quality Control Analyst: Wedgewood Pharmacy, San Jose, CA

• Prime of tablet project

o Full understanding of cGMP requirements, operational GMP, SOP, forms, and quality activities

o Experience with quality control of tablets for hardness, moisture, weight, … o Calibration of tablet hardness and wight before production to reach standard range o Checking hardness and weight of tablets and able to make adjustments during production when needed

o Reading and analysing HPLC results for tablet samples o Familiarity with tablet manufacturing operation, compounding techniques, inspection and packaging

• Prime of environmental monitoring (EM) project

o Wearing gown and getting ready for the cleanroom o Performing EM sampling for IOS 5, ISO 7 and ISO 8 o Incubation of collected EM samples

o Reading the EM sample off the incubator

o Preparation of EM sheet to report the results and delivery to the batch o Evaluation and trending of EM data in Excel

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o Providing EM trend reports with graphs and analysis as per monthly or quarterly basis

o Preparation of samples for analysis at external laboratories o Review laboratory testing of the finished drug product, such as EM, microbiological testing, chemical testing and in-process testing o Lighthouse review during and after the production filling process

• Prime of raw materials project

o Sampling and inspection of raw materials per SOP o Reading results and approval of raw materials and making and adjustment of sage o Writing change control for raw materials

• Other daily responsibilities and skills

o Release of all components and drug product containers o Material approval/rejection

o Investigation and writing of deviations

o Batch record issuance and review

o Review and retain of all records associated with batch production, packaging and labeling

o Line opening and closing

o Conducting fulfilment

o Proficient with Microsoft Office and Excel software

• Leadership and impacts beyond daily responsibilities o Design of an EM sheet form for ease of use by production team o Design of Excel sheet template to efficiently record and track EM results o Improved EM procedure to collect and records results into batches o Modified SOP for EM:

Added requirement to sample sleeves during filling under hood

Added requirement to keep sampled plates in the fridge during holidays to avoid excessive growth of bacteria

SOP tables were updated for better format and understanding o Modification of lighthouse process to avoid frequent false alarms o Collaboration and constant contact with production supervisor to improve EM procedures, remove the flaws and reduce risk of errors o Coordination and assignment of daily/weekly/monthly tasks to other QC team members

Sep. 2018–Mar. 2020 Quality Control/Assurance Analyst: T. Marzetti, Milpitas, CA

• Preparation of industrial ingredients for food productions according to daily/weekly schedules

• Collect samples of raw materials, ingredients, products and/or packages and monitor and test according to SOP, established procedures and GMP compliance. 3 P a g e

• Samples product and performs all physical and chemical tests outlined in the quality assurance manual.

• Monitor critical control points (CCPs) for PH, water activity and metal detection

• Perform routine sanitation verification checks such as environmental swabbing and allergen swabbing. Perform environmental monitoring.

• Responsible for maintaining equipment for proper lab operation. Perform calibration of lab equipment and preventive maintenance when assigned.

• Follow work practices in quality assurance manual and compare test results and standards.

• Document neatly and precisely all results.

• Monitor processes to assure they are operating consistently.

• Label and maintain samples of ingredients or products for retains or shelf life monitoring.

• Identifying potential hazards and solution to collection

• Organize collected data for management review (charts, graphs, tables, etc)

• Accurately weigh colors, flavors and other small ingredients.

• Monitor inventory of lab supplies and communicate with shipping to ensure adequate inventory

• Keep records and samples to support any future investigations for errors

• Continues monitoring of procedures and provide suggestions for improvement

• Test R&D samples for food safety and specification development.

• Maintain lab area and equipment in orderly.

• Recommend methods for improving any processes compliance to reduce waste, improve productivity, improve quality and/or consistency.

• Follow and generally keep aware of the plant GMPs and reports anything which might have a negative effect on our products and company.

• Follow Good Laboratory Practices (GLPs) established by Q.A. and safety guidelines established by plant management.

• Ensure compliance to quality, food safety, 5s, OSHA and HACCP support programs

• Assure conformity to all company, customer and government standard. May 2014–Oct. 2014 BSc internship: Health Food Services (HFS), Ottawa, Ontario, Canada

• Fortification of oatmeal breakfast cereal with flaxseed enhances omega-3 and diary fiber with antioxidant capacity

• The aim of the project was first, to develop a new formulation that contains optimal levels of roasted flaxseed kernel and second, to evaluate chemical and nutritional properties of new formulations needed by HFS. I developed a formulation based on flaxseed such that it improved nutritional and functional properties of oatmeal cereal. To achieve this, different types and percentage values of flaxseed were tested. Also, the chemical properties of flaxseed were measured to evaluate its nutritional values and functionality. For chemical 4 P a g e

and nutritional values of flaxseed, protein, carbohydrates, lipid, fatty acid composition, dietary fiber, moisture and ash/mineral contents were measured. For functionality, antioxidant capacity and phenolic composition were investigated.

• Statistical analysis and conclusion of measured data using SAS

• A thesis, report, and presentation delivered

• Typical lab tasks during this project

o Preparing of testing solutions, samples, and extractions o Equipment calibrations and preparations

o Using lab equipment such as HPLC, ORAC, Moisture Analyzer, ph Meter, IR, Freeze Dryer, Centrifuge, Muffle Furnace, …

o Performing lab measurements, collection of data, and analysis Jan. 2001–Jun. 2001 BSc internship: Pharmaceutical Industry, Quality Control Unit, Tehran, Iran

• Microbiology test: interaction of several bacteria with drugs o To culture oral liquids and dermatological solutions and ointments and counting total number of microorganisms in each millilitre of liquid and identification of some infectious bacteria.

o Sterile control of powders and gradual solutions-topical antiseptics and ear and eye solutions and some of primary ingredients such as starch, gelatine, talk, kaolin, gums, pancreatin, …

o Antibiotics potency test and antibacterial effectiveness determination. o To determine biological quantity of some vitamins and testing turbidity of the resultant culture with an appropriate turbidimetry and to compare with a standard with a similar concentration.

o To determine antibacterial effectiveness of drug preservatives and to compare with phenol.

• Physical test of drugs: shape, hardness ...

• Chemical test of drugs: measuring the chemical compositions of drugs using HPLC, GC and IR

TECHNICAL SKILLS

• How to wear gown and get ready for the cleanroom

• How to sample with TSA and SDA plates to conduct environmental monitoring (EM)

• Batch issue and release

• Sanitation verification checks such as environmental swabbing, allergen

• Measurement of antioxidants capacities using oxygen radical absorbance capacity

(ORAC)

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• Compositions of phenolic and flovonoid extractions according to the established high- performance liquid chromatography (HPLC) method

• Rheology: viscosity analysis (viscometer), texture analysis (texture analyzer), flow rate of pumping assessment

• Sensory: flavor and aroma (ranking test in untrained panel), colour (Hunter lab colorimeter)

• ph meter to adjust ph of solutions

• Hardness and friability testers

• Water activity check

• Familiar with UV, GC, IR, and NIR

• Statistical analysis using SAS

• Extensive experience with Microsoft Office including Excel, Word, and PowerPoint PUBLICATION

Leyli Saadat, Mehri Hadinezhad, and Farah Hosseinian, “Fortification of Oatmeal Breakfast Cereal with Flaxseed Enhanced Nutritional Value and Antioxidant Capacity,” Poster presentation at The Future of Food in Healthcare Conference, Toronto, Oct. 2014. STRENGTHS

• Extensive lab experience and hands-on working

• Familiar with lab procedures and advanced measurement techniques

• I believe in maintaining high standard of work

• Good teamwork with positive attitude

RELATED COURSES PASSED

• Organic Chemistry (I and II)

• Analytical Chemistry (I and II)

• Industrial Chemistry (I, II, and III)

• Physical Chemistry (I and II)

• Inorganic Chemistry (I and II)

• Statistics (I and II)

• Food Chemistry

• Food Engineering

• Food Microbiology

• Food Quality Control

• Food Packaging

INTERESTS

• Lab quality control and assurance

• Pharmaceutical labs

• Food science and nutrition

• Chemical and physical labs

Contact this candidate