Senior QC Scientist

Job Title:

Analytical Chemist - HPLC Specialist Job Description

We are seeking an experienced Analytical Chemist to conduct routine and non-routine analytical testing of raw materials, in-process samples, and finished products. This role focuses on the use of High-Performance Liquid Chromatography (HPLC) and other analytical techniques. As the subject matter expert, you will ensure the operation, troubleshooting, method execution, and data interpretation of HPLC systems.

• Conduct assay, impurity, stability, and release testing utilizing HPLC in accordance with approved methods and regulatory requirements.
• Analyze, review, and document chromatographic data to ensure accuracy, integrity, and compliance with quality standards.
• Perform timely release testing and approval of incoming raw materials and finished goods to support manufacturing operations.
• Maintain, calibrate, troubleshoot, and perform preventative maintenance on HPLC systems and other laboratory instrumentation.
• Investigate analytical deviations, out-of-specification (OOS) results, and instrument performance issues, implementing corrective actions as needed.
• Author, execute, and review analytical testing protocols, validation protocols, IQ/OQ documentation, and technical reports.
• Draft and revise SOPs, test methods, and laboratory procedures to ensure alignment with current GMP and regulatory requirements.
• Perform peer review of analytical data, chromatography reports, test methods, protocols, and laboratory documentation.
• Ensure compliance with cGMP, data integrity, safety, and quality system requirements during all laboratory activities.
• Identify trends in analytical results and laboratory performance data and recommend process improvements to enhance quality and efficiency.
• Coordinate laboratory testing activities to support manufacturing schedules, product release timelines, and customer requirements.
• Prepare detailed technical reports summarizing analytical testing, investigations, and laboratory findings.
• Collaborate cross functionally with Quality Assurance, Manufacturing, and Technical Services teams to resolve laboratory and product quality issues.
• Cross train in multiple laboratory functions to provide flexible support across analytical testing operations.

• Expertise in HPLC or UPLC.
• Strong understanding of Chemistry, Biology, and Analytical Chemistry.
• Proficiency in quality control and wet chemistry.
• Familiarity with FDA compliance and audit management.
• Excellent organizational skills and attention to detail.
• Proven ability to meet deadlines with strong time management skills.
• Strong verbal and written communication skills.
• Ability to function well in a high-paced and sometimes stressful environment.
• Thorough understanding of FDA and cGMP compliance regulations.
• Proficient with Microsoft Office Suite, virtual meeting applications, SAP Business One, and other related software.

• Bachelor's degree in Chemistry, Microbiology, or Biology.
• Working knowledge of scientific instrumentation and techniques.
• Working knowledge of Regulatory, cGMP, and FDA regulations.
• Proficient computer knowledge including basic spreadsheet functions and word processing.
• 2+ years of leadership experience, possibly leading projects with a team.

The work environment includes working around the lab and throughout the facility, assisting with audits and other FDA documents. It requires close collaboration with various teams and demands adherence to high standards of safety and compliance.

This is a Contract to Hire position based out of Omaha, NE.

The pay range for this position is $28.00 - $32.00/hr.

Individual compensation offered for this position within this…