Analytical Chemist II
Job in
Eden Prairie, Hennepin County, Minnesota, 55344, USA
Listed on 2026-07-13
Listing for:
Actalent
Full Time
position Listed on 2026-07-13
Job specializations:
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Long-Term Opportunity | Excellent Industry Experience | Day Shift | Offers Benefits
Job Description
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…
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