SUMMARY:

• Over ten years of professional experience in the field of analytical chemistry, Experienced with HPLC/GC method development and method validation. Diversified analytical skill in analytical instrumentation (HPLC, GC/MS, UV - VIS, TLC, FTIR, ICP/MS, AA, etc), as well as wet chemistry techniques (Titration, extractions, distillation, gravimetric, bolometric, viscometer, pH meter, and electrical methods).
• Excellent problem-solving and method development skills. Extensive experience in SOPs, 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. Familiar with cGMP, OSHA, DEA, PPE, USPs and EPs.
• Extensive (one diploma and one ) in computer software/database with knowledge of Word, Excel and Access (spreadsheet, database, PowerPoint), Internet, etc. To proficiency in Microsoft Word, Outlook, and Excel.

PROFESSIONAL EXPERIENCE:

Confidential (Chandler, AZ)

QC Specialist

Responsibilities:

• Analyzing semiconductor materials in support of product qualification and to support all Quality Control laboratory processes.
• Responsible for analyzing raw materials, intermediates, and final products following company processes and procedure.
• Investigating non-compliance test results to assure the substance meets internal and external specifications.
• Review analytical long-term stability charts to assure laboratory equipment meet fit-for-use criteria. Perform troubleshooting repairs and maintenance activities.
• Reviewing and updating laboratory documents consistent with Good Laboratory Practices.
• Prepare and submit lab work orders and track schedules. Will use some Failure Analysis or LYA sample preparation tools such as solder rework station, optical microscopy, electrical multi-meters, Mechanical Polisher, Milling tools, or Chemical Etching.

Confidential (Tempe, AZ)

Quality Manager

Responsibilities:

• Ensure quality systems are compliant with corporate and site procedures as well as industry standards such as, but not limited to, annual reviews, complaints, investigations and root cause analysis, corrective and preventive actions, supplier qualification, and .
• Responsible for representing the company during regulatory, accreditation, and/or client inspections and audits.
• Responsible for monthly, quarterly, and annual summaries and metrics, as required. Present summary data to senior management on a regularly scheduled basis.
• Develop and manage the management review process.
• Perform and facilitate investigations and root cause analysis.
• Responsible for the supplier qualification program.
• Manage and facilitate documentation of CAPA commitments and respective tracking and trending processes.
• Ensure effective communication and dissemination of CAPA and management review commitments.
• Develop, administer, and maintain the Employee Program.
• Track, monitor, and coordinate cGMP-related for the facility.
• Ensure quality system programs such as CAPA, management review; complaint investigations, inventory control, and the Employee Program remain current to achieve compliance with relevant regulations.
• Ensure the adherence to the standards of quality defined by current Good Manufactory Practices, the company’s quality policies, and site Standard Operating Procedures.
• Support the company’s quality system and initiatives for constant improvement.
• The position includes responsibility for all material testing, calibration, and validations.

Confidential (Gilbert, AZ)

QA Inspector

Responsibilities:

• Responsible for raw material sampling and testing coordination (Including first piece, in-process and final inspections.)
• Some roles specialize in complex products/ processes (across liquids, syringes, tablets, lypolized etc.) Inspects incoming, intermediate, and outgoing materials for proper identification and conformance to approved specifications
• Ensures all materials are sampled and identified (quarantine, approved, on hold, or rejected) in accordance with current Good Manufacturing Practices (GMPs) requirements
• Perform inspection on components and assembled products using measuring and test equipment. Determine and maintain accurate and up-to-date acceptance and rejection records. Determine acceptability of raw materials and/or finished product
• Reads and understands specifications and inspection criteria and applies criteria using appropriate and properly configured inspection tools. Reads and understands schematics and mechanical drawings
• Documents, files and maintains inspection records and participates in annual product visual inspection. Perform internal audits
• Assists in maintaining the collection, retention and storage of finished product and packaging component retain samples. And assists in formulation (fill or make up a prescription). Selection of formula fillings, calculating and accurate on Labeling - supplement face.
• Assists and participates in the distribution, retrieval, and filing of controlled documents (SOPs, specifications, and test methods) as well as other Quality Assurance documents. Participate in the corrective/preventive action program
• May participate in the execution of validation and process improvement activities
• Observe all company policies and procedures, including safety rules.

Confidential (Phoenix, AZ)

Chemist

Responsibilities:

• 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 for developing raw material (ingredients) specifications, starting with CoA ( 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 includes reviewing, correcting/updating or creating Quality master documents, analyzing data, preparing change control documents and reports.

Confidential (Irvine, CA)

Quality Assurance Specialist

Responsibilities:

• 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 are implemented/ maintained
• Develop, administer and maintain the employee 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.

Confidential (Irvine, CA)

Tissue Lab -Chemist

Responsibilities:

• Assist engineers in executing bench top comparison testing to evaluate materials, trouble shoot failures and evaluate improvements.
• Assist in process development and the generation of test methods that provide repeatable and reliable data. Collect and report and analyze test data using various methods.
• Ability to make good scientific judgment when reporting and interpreting analytical results.
• Perform chemical and microbiological testing for medical devices, manufacturing processes, systems, and facilities. Conduct quality microbial monitoring program for medical device manufacture and sterilization, and quality assurance reviews. Work with lab techniques, assays, pipetting, filtration, dilution techniques, and biological indicators. Review and approve environmental monitoring data.
• Perform routine testing within the department, as per established procedures, with minimal supervisory input. Ensure testing is performed in a timely fashion. Responsible for maintenance of current and accurate records of daily work. Record data without relying on a specific framework. May prepare brief data summaries and reports of test data. Provide input to supervisory personnel on procedures in areas of responsibility that need revision updating/review. Perform testing, per schedule, with minimal input required by supervisory personnel.
• Maintain records and file analytical data. Maintain and calibrate laboratory equipment. Prepares solutions and reagents. Logging and preparing samples for Lab. Dishwashing and maintenance in Lab. Other duties as deemed necessary.
• Good eye and hand coordination, Hands-on experience in basic wet chemistry techniques. Hands on knowledge and understanding of GMP’s.

Confidential (Costa Mesa, CA)

Planner (stockroom cleck)

Responsibilities:

• 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 . 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.

Confidential (Irvine, CA)

Quality Control Chemist

Responsibilities:

• Perform or provide oversight for others performing complex analytical processes including the introduction of new technologies, validation/qualification activities, and the testing of raw materials and finished products.
• Follow standard operating procedures and specifications and assures conformance to cGMPs, USP and JP testing.
• Perform basic troubleshooting on assays, tests and laboratory equipment.
• Document results and investigations clearly and accurately.
• Ensure all documentation is legible, complete and correct per cGMPs and SOPs.
• Conduct initial verification of basic documentation..
• Compile data for product release, product trending, investigations, system/document change requests, and report write-ups.
• Perform other lab related tasks determined by the area management.
• Organize and maintain accurate product regulatory information.

Confidential (Irvine, CA)

Quality Control Technician

Responsibilities:

• Inspected, evaluated and tested products to Medical Device Standards for compliance with Quality System Requirements for a medical device manufacturer.
• Maintained knowledge of requirements in: test standards, supplier standards, receiving standards, process standards, packaging standards, and specification including Artwork (Medical DMR’s) to determine compliance for medical device manufacturing and cGMP.
• Responsible for verifying that finished product met all requirements of the device master record (DMR) all documents are completed.
• Set up and operated equipment such as GC, Instron, FTIR, Karl Fisher, Sartorius moisture tester, Brinkman titroprocessor (Metrohm), Brookfield viscometer, and Minolta CR 200 Chroma Meter.
• Selected chemicals, raw materials or products, for tests at specific stages in production process.
• Performed quality laboratory tests for qualities such as viscosity, amine, acid, resin content, ring strength, seal strength, flat laminate strength, and colors using a variety of precision laboratory equipment.
• Recorded test data results in Excel or Minitab, applying statistical quality control procedures.
• Evaluate data and wrote Supplier Corrective Action Request (SCAR) in Lotus Notes and Quality Inspection Report (QIR) in Microsoft Access Database to document deviations from standards.
• Took initiative to recommend improvements of existing quality or production standards and process to achieve quality or productivity improvements, and provide additional QA to products.
• Inspected, product packaging and labeling requirements.

Confidential (Tustin, CA)

Chemist

Responsibilities:

• Tested inorganic and organic ingredients, vitamins, amino acids and minerals by applying HPLC (Beckman/DAD168), GC (HP 5890A/FID), TLC and spectroscopy technologies.
• Assisted with analytical method development.
• Released raw materials, in-process samples and finished products.
• Performed instrument qualification and calibration according SOP/GMP requirements.
• Under immediate supervision, prepared biological specimens for testing including logging, labeling, inoculating, staining, filtering, transferring, and mounting.
• Prepared media, reagents, stains, and sterile solutions.
• Assisted Microbiologist. Ordered supplies.
• Assists in record keeping, data entry and preparation of routine reports.
• Wastewater analysis and wastewater treatment system management.
• Water purification (ion exchange chromatography) and quality analysis.
• Wrote GLP standard operating procedures for water treatment and qualification.
• In charge of determining the trace metal content of drinking water, wastewater, hazardous waste, liquid, soil and some air samples.