Responsible for 3rd party testing, Annual Drug Review Reports, Quality Validations, Supplier/Vendor Qualification, SOP, NDA/Quality Agreements and some site registrations, Facilitating multiple tasks: internal and external audits, completion of CAPA/NC/Complaints and QRB review. Member of several PCPC committees

Manage internal R&D regulatory support and training through Product Vision software. Support of customers needs including information for dossier registration, ingredient labeling and coordination of testing to 3rd party labs (safety testing, package compatibility, OTC Drug products, inorganic concerns). Assist with Certification for product line claims.

• Responsible for formula compliance from initial input through reporting regulatory details to customer• Provide regulatory guidance to R&D chemists during product development• Develop and issue regulatory documents for customers to support all of their needs• Improve systems, procedures and programs to streamline raw/formula entry, review and reporting• Support customer registration needs through external organizations and testing laboratories

• Works closely with suppliers to obtain regulatory documents and information for raw materials• Inputs all raw material information into QAD• Responsible for formula compliance from initial input through reporting regulatory details to customer• Develop and issue regulatory documents for customers

• Responsible for ensuring that the quality system is implemented and followed at all times as defined under NELAC • Serve as the focal point for QA/QC and be responsible for the oversight and/or review of quality control data.• Organize the validation of instruments and analytical methods• Review and maintenance of standard operating procedures ( SOPs) for accuracy and clarity• Coordinate with the Environmental, Health, and Safety committee to promote a safe work environment• Work with instrument vendors for technical support • Notify laboratory management of deficiencies in the quality system and monitor corrective action.• Conduct internal audits as per NELAC requirements

• Supervise all aspects of and personnel for the inorganic chemistry section• Adherence to all quality assurance/quality control (QA/QC) requirements as specified in the Quality Manual and associated Standards Operating Procedures• Responsible for inspection and record keeping for all supplies received by the laboratory• Oversight for all technical efforts of metals sample preparation to ensure their accuracy• Review and updating of SOPs to ensure that they reflect actual laboratory practices• Operation and maintenance of ICP-OES and CVAA to ensure the accurate and timely analysis of samples for inorganic elements

• Supervise aspects of and personnel for the metals chemistry section • Digestion of a variety of samples for inorganic metals including soils, wastewater and drinking water following EPA and state approved methodologies• Analysis for mercury and metals using CVAA and ICP-OES. Performed maintenance for ICP-OES equipment.

• Microbiology sample analysis for total and fecal coliform• Colorometric and spectrophotometric analysis for wet chemistry.• Metals digestion of all sample matrices using CLP, EPA and state approved methodologies• Analysis for mercury and metals using CVAA and ICP-OES. Performed maintenance for ICP-OES equipment.