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Quality Assurance

Chandler, Arizona, United States
January 20, 2017

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Email: Phone: 949-***-****


Gansu Community College, China (Business and Finance) 1997

Lanzhou University, China (B.Sc. in Analytical Chemistry) 1989

Professional Profile

Over years of professional experience in the field of analytical chemistry.

Excellent problem-solving and method development skills. Extensive experience in SOPs, GLP and cGMP as well as quality control role in manufacture and contract laboratories. Quickly transform former experience into the new professional area to meet new requirements, especially good at handle multiple tasks simultaneously.

Extensive training (one diploma and one certificate) in computer software/database with knowledge of Word, Excel and Access (spreadsheet, database, PowerPoint), Internet, etc.

Employment History

Marlyn Nutraceuticals,Inc May, 2015-May, 2016

QC Technician

Perform and develops laboratory testing including but not limited to: ~ FTIR, ~ Ion Chromatography, ~AA, ~ HPLC Etc. follows all safety and testing policies.

Complete testing per work instructions accurately and in a timely manner as assigned.

Demonstrated ability to be innovative and improve laboratory performance through continual improvements of lab quality, test capabilities, organization and efficiency. This would include maintenance of the laboratory of common lab consumable items, and schedule periodic calibration and maintenance on equipment as needed.

Review solid dosage master formulas for tablets, capsules and functional food powders; calculate finished product nutritional values, prepare supplement facts, review finished product labels, prepare raw material specifications, prepare finished product specifications, prepare stability protocols, review master manufacturing batch records, review master packaging batch records, as well as prepare reports, and technical analysis to ensure Quality activities are carried out in compliance with GMP regulations for dietary supplements.

Responsible to develop raw material (ingredients) specifications, starting with CoA (certificate of authenticity) and the investigation and determination of appropriate analytical test methods, including already published methods.

Creation of BOM (bill of materials): Must be able to check them against master formula. (Being precise, focused and detailed is very important.)

Day to day activities include reviewing, correcting/updating or creating Quality master documents, analyzing data, preparing change control documents and reports.

PacifiCord Inc. (A HealthBanks Biotech Company) March, 2012-May, 2015

Quality Assurance Specialist

Responsible for company’s Quality Systems. Perform audits and assessments of lab, support areas and quality systems. Identify, investigate, correct and monitor compliance gaps and quality system concerns.

Conducts reviews of documentation and reports for conformance to procedures, protocols and regulatory requirements.

Assist in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc.

QA inspection and release of vendor supplies, Perform and facilitate investigations and root cause analysis. Ensures Lab performance and quality goals are met.

Responsible for document control process, Review SOPs coordinate method development and ensures concurrency with cGMP regulations and requirements.

Responsible for the documentation and investigation of department deviations, CAPA’s and out of specifications / out of tolerance results.

Responsible for monthly, quarterly and annual summaries/ internal and external audit as required, participant in second party supplier and third party (FDA, AABB, and ISO) audits.

Ensure requirements for certification are implemented/ maintained

Develop, administer and maintain the employee training program

Knowledge quality system regulations (21 CFR820) and ISO standards, knowledge of GLP documentation and FDA required.

Assist with processing diagnostic, validation and clinical trial samples defined by standard rating procedures in compliance with CLIA regulations, as it pertains to specific assays. Support quality initiatives and projects within the business unit.

Lambda Research Optics, Inc. March, 2007-September, 2011

Planner (stockroom cleck)

Responsible to support and facilitate the company's strategic planning and execution of the arterial requirements fulfillment plan programs.

Analyze/plan/monitor and update the company's MRP and MPS activities to ensure maintenance of appropriate levels of finished goods, Work in process and raw material supply that optimize the company's service and cost objectives.

Coordinate and issue all work in process (WIP) to designated locations and assures all documentation of work orders is transacted in ERP.

Evaluate and manage plant rough-cut capacity planning requirements.

Develop a working knowledge of the company's products and processes to ensure master schedule stability in order creation, rescheduling, load leveling etc.

Interact with Purchasing, Production, Inventory Control to help develop and maintain appropriate policies and practices that optimize company inventory objectives.

Develop plans to prevent or minimize slow moving and obsolete inventories.

Assist with monthly, weekly and daily cycle counts.

Organize and maintain accurate product regulatory information.

Update and maintain a database of process training. Provide reports from data collected.

Receiving inbound products, checking for accuracy and sorting into inventory. Entering shipping information into the computer and preparing pallets for freight pick-up.

Maintaining an assigned inventory area including restocking.

Experience with analysis techniques such as X-ray and Optical Inspection.

Perform chemical cleaning, Conduct electrical test.

Knowledge in X-section, CSAM and other Failure analysis skill set.

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