Quality Control Assurance
Resume:
AKSHI PATEL
North Bergen, NJ 07047
Cell Phone # 281-***-****
*********@*****.***
OBJECTIVE
To obtain a challenging laboratory/ research / quality control/ quality assurance position as lab analyst/ quality control/assurance with in the Nutraceutical/pharmaceutical/food industries/hospital.
PROFESSIONAL EXPERIENCE
COMMAND Nutritionals LLC July 2008 - Present
Quality Assurance & Quality Control Manager
o Enforcing the quality policies and procedures, and for participating in continuous improvement of the production and process control system.
o Generating and approving and/or rejecting of all processes, specifications, written standard operating procedures (SOP), controls, test and examinations, and planned or unplanned deviations from or modifications to them that may affect the identity, purity, strength, or composition of a dietary supplement.
o Ensuring that the manufacturing, packaging, labelling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labelled as specified in the Master Manufacturing Record.
o Reviewing and approving of the basis and the documentation for why any product specification is exempted from the verification requirements. and for why any component and in-process testing, examination, or monitoring, or other methods will ensure that such exempted product specification is met without verification through periodic testing of the finished batch.
o Qualifying a supplier, contract manufacturer, contract packager, pest control service provider, metrology service provider, or laboratory where products or materials are tested.
o Ensuring representative and reserve samples are collected for finished product are collected and held and tested/examined according to component/product specifications.
o Ensuring that the most current SOP and processes are being followed.
o Ensuring that personnel have been properly trained to competently and efficiently complete their assigned job functions.
o Reviewing and approving of all corrective actions related to quality.
o Reviewing and approving of all Master Manufacturing Records and all Batch Production-related Records all modifications to the Master Manufacturing Records.
o Developing, reviewing and approving of each finished product specification and also raw material specifications.
o Train employees for cGMP/cGLP practices, safety, personnel hygiene, preventing of cross contamination in manufacturing and packaging process, hazardous waste management and individual on job training as required within the Nutraceutical industry.
o Conducting analytical method development and validation and updating standard assay methods with Waters Acquity UPLC (Ultra Performance Liquid Chromatography), Sartorius Mark 3 Moisture Analyzer, Digital Refrectometer, ESPEC Accelerated Stability Study Chamber, FOSS NIR, and FOSS Kjeltec System for Protein Analysis and approving the test results.
o Conducting Organoleptic/sensory testing for Finish Dietary Supplements and Raw Materials (like Botanicals, Sweeteners, Flavors, Colors,etc.).
o Conducting assay and dissolution for dietary ingredients and supplements using Waters Acquity UPLC (Ultra Performance Liquid Chromatography) and Empower 2 & 3 software.
o Conducting protein assay/analysis using FOSS Kjeltec System and Compass software.
o Conducting identification test and analyzed raw materials intermediates using Foss NIR and Vision Software.
o Performing trouble shooting with instrumentation related to problems as necessary.
o Reviewing and approving of all processes for calibrating instruments and controls to include periodically reviewing all records for calibration of instruments and controls; periodically reviewing all records for calibrations, inspections, and checks of automated, mechanical, or electronic equipment; and reviewing and approving controls to ensure that automated, mechanical, or electronic equipment functions in accordance with its intended use.
o Product development and Flavor development of the powder products.
o Handling, reviewing product/customer complaints.
Madhav Agro Foods Pvt. Ltd. May 2005 – Jan 2006
Lab Analyst
o Analytical method development with Digital Refrectometer, Acidity Testing, Alkaline Testing, Water Quality Testing and Protein Analysis and approving the test results.
o Product development and flavour development of the pickles, pests, jam & jelly products.
o Review and approval of the basis and the documentation for why any product specification is exempted from the verification requirements. and for why any component and in-process testing, examination, or monitoring, or other methods will ensure that such exempted product specification is met without verification through periodic testing of the finished batch.
o Develop, review and approval of each finished product specification and also raw material specifications.
EDUCATION
• Masters in Human Nutrition (GPA-3.82) (Graduated in Jan 2010)
University of Bridgeport, Bridgeport, Connecticut, USA
• Bachelor of Science, Majoring in Food Science and Quality Control (GPA-3.91) (Graduated in May 2007)
Faculty of Home Science, Maharaja Sayajiroa University, Vadodara, Gujarat, India
SKILLS
Instrument: Acquity UPLC (Waters), Moisture Analyzer (Sartorius Mark 3), Digital Refrectometer, NIR – Near Infra Red (FOSS), Kjeltec System for Protein Analysis (FOSS), Accelerated/Environmental Stability Study Chamber (ESPEC).
Software: Waters Empower 2, Waters Empower 3, Foss Compass, Foss Vision, Microsoft Office – Word, Excel, PowerPoint, Outlook Express, QuickBooks.
Professional: Quick learner, very punctual, honest, trustworthy, hardworking, polite, Good at setting priorities, leadership, teamwork and knowledge of research techniques and report writing
TECHNICAL TRANING/SEMINAR
• EAS Consulting Group (Dietary Supplement Labeling Compliance Review Seminar) Fairfield, NJ
• Natural Product Association (An advance course on the FDA GMPs for Dietary Supplements) Secaucus, NJ
• Waters Corporation (Empower 3 Software Advanced Topics with Lab) Milford, MA
• Waters Corporation (Empower 2 Software Advanced Topics with Lab) Milford, MA
• Waters Corporation (Effective UPLC Implementation) Parsippany, NJ
REFRENCES
Available upon request
Contact this candidate