Validation Chemist

Certified Laboratories Inc is seeking a highly skilled Validation Chemist to join our team on a 3-6 month contract project. As a key member of our analytical chemistry team, you will be responsible for performing analytical method validations to ICH guidelines, developing analytical test methods, and troubleshooting complex methods.

• Method Validation: Perform analytical method validations to ICH guidelines, including documentation and data generation as required.
• Test Method Development: Develop analytical test methods for analysis of a range of active pharmaceutical ingredients, over the counter (OTC) drugs, cosmetics, nutritional products, and supplements using a range of laboratory techniques.
• Troubleshooting: Troubleshoot difficult methods or products, including investigation of out of specification (OOS) results.
• Routine Testing: Perform routine testing of customer products to GMP requirements.
• Team Collaboration: Assist in overseeing work conducted by lab technicians or assistants and work cross-functionally to assist all departments in response to business needs.

• Education: Bachelor's degree in chemistry or equivalent.
• Experience: Minimum of 3 years of experience working in an analytical laboratory, with 5+ years of experience preferred.
• Skills: Familiarity with 21 CFR 210 and 211 and ISO 17025 standards, experience performing analytical test method validations and verifications, and previous experience in 3rd party product testing of raw materials, OTC products, dietary supplements, vitamins, and nutritional products.
• Equipment Knowledge: In-depth knowledge and experience with major analytical testing equipment such as HPLC, GC, and ICP.
• Soft Skills: Good attention to detail, ability to follow protocols and SOPs, ability to statistically analyze and review data, and ability to produce summary reports.

• Physical Demands: Dexterity of hands and fingers to operate a computer keyboard, mouse, and to handle other communications/computer components.
• Environmental Factors: Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens.
• Work Environment: Interactive and fast-paced team-oriented tasks, with occasional overnight travel required at the discretion of management.

• Retirement Plan: Progressive 401k Retirement Savings Plan.
• Insurance: Employer-paid Short-Term and Long-Term Disability, and Life Insurance.
• Medical Benefits: Group Medical.
• Tuition Reimbursement: Available.
• Flexible Spending Accounts: Available.
• Dental Benefits: Available.
• Paid Holidays and Time Off: Available.