Quality Assurance & Product Chemistry Specialist
DuPont Industrial Biosciences has an opening for a Quality Assurance & Product Chemistry Specialist in the North American Region, located at the DuPont Experimental Station in Wilmington, DE.
This role is responsible for monitoring the studies that are carried out according to Good Laboratory Practices (GLP) in the Microbial Control business. These studies are carried out on active ingredients and biocidal products to meet global regulatory requirements, and are primarily carried out by the Microbial Control R&D Analytical Group.
Studies carried out in the U.S. to generate data on biocidal actives and products for regulatory submissions must be done according to the U.S. EPA’s FIFRA Good Laboratory Practice Standards (40 CFR Part 160) which requires that these studies be monitored by a Quality Assurance Unit.
The role of the Specialist will be to monitor studies and to carry out additional QA duties to assure management that our facilities, equipment, personnel, methods, practices, records, and controls are in compliance with the GLP regulations. The role also involves contracting and monitoring studies at external GLP laboratories to supplement internal capabilities.
Microbial Control’s products are highly regulated; the success of the business depends on obtaining and maintaining product registrations and authorizations globally. The Quality Assurance Unit is a key contributor to Microbial Control’s success.
Specific Responsibilities Include:
• Review of study protocols, inspection of studies in progress, and auditing of reports – for in-house GLP studies. Issuing of an audit report for each of these activities. Typical study types include: 5-batch analyses for active ingredient and impurities, test method validations, storage stability studies, and the characterization and (re)certification of the analytical standards used in GLP studies.
• Maintenance of the master schedule of studies in Microsoft Access and maintenance of physical study files.
• Maintenance of CVs and training records for GLP personnel.
• Carrying out periodic refresher GLP training and/or extensive GLP training for new people, as needed.
• Carrying out facility inspections of in-house GLP labs, and of contract labs (as needed)
• Auditing GLP analytical work and reports from external laboratories
• Assuring that study records are archived and that samples are properly retained in the GLP sample archives.
• Assuring that QAU SOPs and SOPs relevant to Microbial Control GLP studies are adequate and current. Requesting/creating/updating SOPs as needed.
• Communication with management on status of current GLP studies and activities and timely reporting of any compliance concerns.
• Serving as study monitor for external studies and coordinating these studies with external labs.
• Carrying out internal audits to ensure regulatory compliance
• Working with the global Microbial Control Regulatory Specialists to define the product chemistry testing needed for new and existing MC actives and products.
Critical Success Factors:
• Exceptional attention to detail and organizational skills
• Creative problem solving skills
• Excellent technical writing and oral communications skills
• Strong interpersonal skills
• High level of computer proficiency
• Bachelor’s, Master’s or PhD degree in a scientific field is required, preferable chemistry
• Broad science work experience and skill set, preferably in analytical chemistry
• Minimum 3 years laboratory experience in chemicals, biocides or plant protection products
• Laboratory experience in chemicals, biocides or plant protection products
• Training or experience in Quality Assurance as per U.S.EPA 40 CFR Part 160
• Familiarity with global GLP guidelines
• Familiarity with U.S. EPA product chemistry data requirements (OPPTS Series 830) and EU Biocidal Product
• Regulation product chemistry data requirements (EU528/2012)
• Work experience as a Study Director carrying out studies according to U.S. EPA 40 CFR Part 160
• Laboratory experience in wet chemistry and in the analysis raw materials and finished products by HPLC and GC
• Experience in use of Microsoft Office Suite