Quality Analytical Chemist

QUALITY ANALYTICAL CHEMIST

Role Summary

Provide corporate quality support for analytical test methods in the following areas:

• Maintain and ensure existing methods for all Pilot/Mason products are current and accurate.
• Improve/optimize existing methods.
• Implement and maintain a Round Robin program as assigned.
• Train plant/external supplier/customer laboratory personnel.
• Assist plant/external supplier/customer laboratory in instrument troubleshooting.
• Provide technical expertise in support of instrument evaluation, purchase, installation and training.
• Conduct and close GLP studies as the Study Director and Technical Writer.
• Support others with projects in the following areas:
• Development of new or improvement of existing products.
• Plant process development or improvement.
• Environmental or other regulatory affairs, including EPA GLP.

• Primary responsibility for Analytical Test Method verification and optimization.
• Develop Change Requests for methods, as needed.
• Coordinate and perform Physical Properties and Stability testing as needed.
• Primary responsibility for final Analytical Test Method Validation.
• Lead Analytical Test Method transfer and training and qualification of plant/external supplier/customer QC labs.
• Laboratory support for ISO 9001 compliance.
• Track plant QC lab performance by use of Round Robins and other qualification tools.
• Receive feedback from QC labs and develop continual improvement plans for Analytical Test Methods with Technology group.
• Aid with troubleshooting in QC labs.
• Assist with corporate lab Management System governance and auditing.
• Assist with Plant NCP and CC investigations, where needed.
• DCI/EPA compliance Work/Test Method Validation.
• FCN Technical Support.
• Management System auditing of QC Labs.
• Interface with customer regarding customer-supplied analytical test methods.
• Issue status updates, summaries, and reports in a timely fashion.
• Plan and complete other assigned tasks and responsibilities.
• Responsible for ensuring compliance with the Pilot Integrated Management System including the establishment of policies and procedures, assigning responsibilities and tracking progress.
• Review and approval of draft CSFs (Confidential Statement of Formulas) for chemistry logic and math.
• Coordinate with suppliers and contract manufacturers to obtain appropriate sample materials.
• Prepare samples required for DCI submissions including Chemistry, Toxicity, and Efficacy as required (both GLP and non-GLP testing requirements). Work in conjunction with Technology to modify formulations to ensure stability and effectiveness.
• Conduct method validation by product and prepare validation reports.
• Coordinate with outside or internal labs to obtain, review and approve Chemistry Protocols.
• Prepare and send appropriate samples to external labs as appropriate.
• Conduct GLP testing on representative samples that reflect CSF formulations.
• Review draft Chemistry report from external lab and coordinate with lab to finalize report.
• Prepare and finalize MMPs (Master Manufacturing Procedure) and CRMs (Customer Registered Methods). Coordinate with contract manufacturers where appropriate.
• Maintain the laboratory, including standardizations, calibrations, and cleaning as necessary.
• Perform routine clerical work, including updating the physical properties database (PPD), maintaining the chemical and product inventories, requesting and shipping samples, etc.
• Provide routine updates to the business regarding progress on projects.
• Maintain electronic systems and records according to 21
  
  CFR Part 11 requirements where needed for GLP compliance.
• Responsible for ensuring compliance with the Responsible Care Management System®.

• Minimum of bachelor’s degree in Chemistry or related field.
• Minimum of five years’ experience.
• Must have familiarity/expertise with the following instrumentation and test methods:
• HPLC, GC, LC, IC.
• GC‑MS, LC‑MS.
• FTIR.
• pH, titrations, wet chemistry.
• Karl Fischer.
• Demonstrated physical manipulative skills needed for general laboratory practices.
• Good subordinate and peer relationship skills.
• Successful record of problem solving through analytical and creative thinking skills.
• Quality Management…