Analytical Chemist

Analytical Chemist II

Long-Term Opportunity | Excellent Industry Experience | Day Shift | Offers Benefits

The Analytical Chemist II plays a key role in ensuring that raw materials, bulk products, and finished goods consistently meet customer and regulatory analytical requirements. This position supports a fast-growing manufacturing operation by validating analytical methods, performing complex testing, and maintaining high standards of quality in a cGMP laboratory environment. The role is part of the quality team at the Eden Prairie facility and serves as a senior technical resource within the lab.

Responsibilities

• Validate analytical procedures, test methods, chemical assays, and laboratory processes used to detect and identify active ingredients to ensure compliance with customer and regulatory guidelines.
• Validate analytical test methods for testing controlled articles, including raw materials, bulk product, and filled product, to ensure methods are robust, reliable, and compliant.
• Calibrate, monitor, and maintain laboratory test equipment to ensure accurate and reliable analytical results.
• Accurately record all data and pertinent information in accordance with current Good Manufacturing Practices (cGMP).
• Create and maintain monthly Key Quality Indicators (KQI) in a timely and accurate manner to support continuous improvement and quality reporting.
• Conduct detailed batch record reviews to verify compliance with cGMP practices and identify potential issues or deviations.
• Document out-of-specification (OOS) situations, determine root causes, and recommend or support corrective and preventive actions (CAPA).
• Lead OOS investigations, review findings, and approve analytical data and product release (ADPRs) for fill and stability studies.
• Ensure analytical specifications are met for raw materials, bulk product, and finished goods, and that all results are documented and maintained to meet customer expectations.
• Report test results clearly and promptly, and ensure accurate and timely transition of quarantined raw materials, bulk product, and finished products based on those results.
• Troubleshoot out-of-specification situations by identifying potential causes, recommending solutions, and implementing corrective actions where appropriate.
• Ensure Good Laboratory Practices (GLP) are followed and align with applicable regulatory guidelines.
• Maintain laboratory notebooks in a complete, accurate, and up-to-date manner to ensure traceability and data integrity.
• Participate in internal and external audits by providing documentation, explaining laboratory processes, and supporting audit readiness.
• Promote and institutionalize 5S principles (Sort, Straighten, Shine, Standardize, Sustain) in all aspects of the department to maintain an organized, efficient, and safe laboratory environment.
• Work closely with Analytical Chemists and QC Chemists in a collaborative team setting to support testing, investigations, and continuous improvement initiatives.
• Serve as a senior technical resource within the laboratory by providing mentorship, training, work review, troubleshooting support, and quality control assistance to other team members.
• Support a high-volume, fast-paced production environment by adapting to changing priorities and workloads while maintaining quality and safety standards.

Essential Skills

• Bachelor's degree in Chemistry or a related scientific discipline.
• 3+ years of industry analytical chemistry experience, including hands-on work with HPLC, GC, and USP methods.
• 2+ years of experience with analytical method development or optimization.
• Demonstrated experience working in a cGMP laboratory environment.
• Strong practical knowledge of analytical chemistry techniques, including HPLC and GC.
• Experience with gas chromatography (GC) and related instrumentation.
• Experience with HPLC and GC method development in a quality control or analytical laboratory setting.

Additional Skills & Qualifications

• Previous experience with method validation is a plus.
• Experience using Empower or similar chromatography data systems is beneficial.
• Experience working with Key Quality Indicators (KQI) or similar quality metrics.
• Familiarity with 5S or other…