Experience

Specialty Enzymes & Probiotics

• United States
• Wellness and Fitness Services
• 1 - 100 Employee

• Quality Control Laboratory Supervisor

  • Feb 2017 - Present

  • Scheduling and implement daily priorities in the QC Laboratory.• Planning and scheduling preventive maintenance and calibration for QC lab equipment.• Provide total assistance for improving the efficiency and output of laboratory analysis and techniques. • Ensure the laboratory is equipped adequately and that all equipment is being properly calibrated and documented.• Review lab results and signing laboratory notebooks.• Writing and review SOP’s based on FCC, USP, Japanese, European pharmacopeia method and AOAC new revision Change Request Document.• Maintain a GMP-compliant analytical laboratory and a safe working environment.• Manage the IQ, OQ, and PQ of new analytical instrumentation.• Performed analysis by pH meter, FTIR, ICP, HPLC, ELISA, water content, LOD, and UV spectrophotometer.• Processing contract samples, create a test record sheet according to what needs to be tested.• Assist Chemist and Micro with instrumentation or assay difficulties• Perform analysis of raw materials, finish goods and incoming lab samples following approved procedures.QA Department:• Review and audit Master Manufacturing Record (MMR) and Batch Production Record.• Develop and maintain regulatory documentation for international customers.• Weekly inspection of the facility.• Planning and scheduling preventive maintenance of production equipment and calibration.• Maintained production inventory.• Ensure GMP requirements are met for Quality Control Operations.• Conduct monthly meetings.• Assist in investigations and corrective and preventive actions (CAPA).• Ensure departmental compliance with procedures, GMP records, and associated forms.• Routinely conduct internal audits and assures employee compliance with GMP and NSF guidelines.• Ensure control of Allergens and compliance with the Allergen Control Program.• Conduct routine verification of batch samples against specifications.• Coordinates equipment sanitation and swab testing on production equipment



Wellnext

• Chemist II

  • Aug 2015 - Nov 2016

  •Establish and implement priorities in the QC Laboratory (Wet Chemistry and Microbiology)•Provide total assistance for improving efficiency and output of laboratory analysis and techniques. •Ensure the laboratory is equipped adequately and that all equipment is being calibrated properly.•Lead, review and trend laboratory investigations from aberrant data, system suitability failures.•Review laboratory notebooks, data pack, and report as directed.•Maintain a GMP-compliant analytical laboratory and safe working environment.•Placed orders for all laboratory reagents, equipments and supplies.•Track record developing and validation GMP- compliant HPLC methods to asses vitamins product stability.•Experience diagnosing and troubleshooting HPLC instrumentation, and addressing OOS and OOT results.•Perform chemical testing on raw materials, finished products and stability samples according to applicable procedures.•Execution of chemical analysis using well known analytical techniques of Gluten, Vitamin C, Aflatoxin, HPLC, FTIR, HPLTC by Camag, LOD, pH and Moisture.•Analyzed and interprets test data and prepare release form report.•SAP experience.



Horner International

• QC Manager & Chemist

  • Jul 2014 - Jun 2015

  Chemist: As a Food Company Responsibilities include: • Responsible for receipt of materials, aseptic aliquoting of samples from bulk source, forecasting test submissions, preparing appropriate documentation, retrieving and labeling samples, maintaining accurate inventory, and submission of samples to testing laboratories.• Sensory Evaluation and consumer taste panel.• Prepare and perform basic organoleptic tests on finished goods and raw materials.• Use of FileMaker (Mac) to manage documents such as QC results, inventory, production, etc.• Writing/review of SOP’s and management of projects.• Extractions of new raw material prior to production.• Supported the cleaning and validation of glassware.• Tracking sample results and in results to the system.• Responsible for all analytical work plant, incoming raw material, components, bulk and finish goods by GC, pH, Karl Fisher FTIR, HPLC, Particle Size, Moisture, TOC, LOD, Solubility, Loss on Drying, Refractive Index, Viscosities, Density and Acidity.• Maintenance and calibration of laboratory and production testing equipment.• Ensure that project timelines and production schedules are met while maintaining product integrity/quality. • Monitored plant operation to ensure in compliance with GMP’s, OSHA GLP, Allergen’s, Pest Control and HACCP developed and implemented policies and procedures.• Responsible for meeting with the Rabbi for Kosher certification.• Supervise scale up of new formulation in pilot plant and production.



MAPEI Corporation

• Formulation Chemist

  • Dec 2007 - Mar 2010

  Formulation Chemist: Responsibilities include: • Supervision and management of laboratory developing cementitious patches.• Formulation and testing (ANSI, ISO, ASTM) of new products, (Taber abrasion, Instron testing machine, pH, Brookfield viscometer, freeze and Thaw weathering chamber, Vicat stability test, linear movement).• Revision and improvement (including cost reduction) of formulas of existing products.• Supporting customer technical service (including complaint investigation).• Maintenance and calibration of laboratory testing equipment.• Supervision of scale up batches of new and improved product formulas at manufacturing plants.



HENKEL LOCTITE

• Research Chemist

  • Dec 1992 - Mar 2007

  Research Chemist: Responsibilities included: • Facilitation of new product transfers and new equipment and equipment validation prior to production batches.• Investigation of customer technical complaints and final report.• Quality control testing, of raw material, finish product, stability test of adhesive products.• Implementation of SOP revision audits, FTIR, HPLC, GC, titration, laboratory inventory control and equipment calibration Research Chemist: Responsibilities included: • Facilitation of new product transfers and new equipment and equipment validation prior to production batches.• Investigation of customer technical complaints and final report.• Quality control testing, of raw material, finish product, stability test of adhesive products.• Implementation of SOP revision audits, FTIR, HPLC, GC, titration, laboratory inventory control and equipment calibration



PFIZER PHARMACEUTICAL

• Chemist

  • Jun 1991 - Dec 1992

  • Chemist: Responsibilities included: Facilitation of new product transfers and new formulation.• Quality control testing: ph, water treatment, FTIR, HPLC, GC, viscosity, conduct a Endotoxin, Environmental and air testing.• Execution of chemical analysis using well known analytical techniques of HPLC, GC, Karl Fisher titrations and TLC coupled with data interpretation to determine the extent of reaction completion. • Implementation of SOP revision audits, laboratory inventory control and equipment calibration.• Execution of GMP driven plant audits• Implementation and execution of ETO residual studies by Gas Chromatography and ETO sterilization validation