QC Quality Analyst

Description

Reports to: Quality Assurance Manager / QC Lab Manager

FLSA Status: Hourly, Non-exempt

Direct Reports: None

Job Location: On-site

Functional Job Summary

The QC Quality Analyst is responsible for supporting the quality control and quality assurance functions through advanced analytical testing, data trending, and cross-departmental communication. This role ensures raw materials, in-process batches, and finished products meet established quality and regulatory standards. The Quality Analyst performs complex chromatographic and instrumental analyses, supports laboratory systems, and contributes to continuous improvement and troubleshooting efforts across the organization.

Duties And Responsibilities

Material & Product Performance Review

• Trend and evaluate incoming raw materials and vendor performance.
• Develop, maintain, and support NIR database modeling and testing.
• Conduct scheduled product trending to identify performance issues before batch release.
• Perform chromatographic analyses, including:
• Headspace GC evaluation for 1,4 Dioxane, Ethylene Oxide, Propylene Oxide, Methyl Chloride, and Allyl Glycidyl Ether.
• GC direct-injection purity testing.
• HPLC impurity analysis.
• Complete additional material evaluations as assigned.
  

Quality Support & Continuous Improvement

• Compile and assemble data for post scale-up reviews.
• Support analytical equipment repair, maintenance, and qualification activities.
• Perform Stability Program testing and maintain retain sample tracking.
• Participate in corrective action investigations (CAT, PIR, customer complaints).
• Assist QA/QC Managers with quality projects and test optimization initiatives.
  
  

Administrative & Quality Systems

• Monitor and maintain lab control systems.
• Serve as a floater to support QC testing during absences.
• Track QC departmental goals and assist with documentation control.
• Support ongoing lab systems improvements and help train new personnel.
  
  

Communication & Collaboration

• Maintain daily and monthly standards documentation.
• Provide clear updates to lab technicians regarding production run status, potential issues, and overlapping analytical needs.
• Communicate with cross-functional teams (Production, Customer Service, Sample Department, etc.) regarding batch adjustments, product codes, and testing requirements.
• Lead troubleshooting efforts for problem batches and support decision-making with production teams.
• Demonstrate strong interpersonal skills, promoting an effective laboratory service function and a positive internal–external customer focus.
  
  

Laboratory Operations

• Service and maintain GCs, HPLCs, and NIR instruments at required intervals.
• Test and track stability retain samples.
• Assist with closing QC sheets, SQC data entry, and revisions to QA procedures and documents.
• Maintain a clean, organized, and efficient laboratory environment.
• Provide coverage during staff absences and perform other assigned duties.
  
  

Requirements

Requirements

• Bachelor’s degree (preferred) with emphasis in Chemistry or related scientific discipline.
• 3–5 years of analytical laboratory experience.
• Proficiency with analytical instrumentation (GC, HPLC, NIR); willingness to pursue external training as needed.
• Ability to perform effectively in a high-stress, fast-paced, multi-tasking environment.
• Strong communication and interpersonal skills.
• Solid math and computer proficiency (Excel required; Chempax a plus).
• Regular and reliable attendance. Required to be on-site.
  
  

Physical Requirements

Physical ability to perform the essential job functions of the position, which includes prolonged periods sitting at a desk and working on a computer performing repetitive hand movement and fine coordination, occasionally stoop, bend, kneel, crouch, reach, and twist; to lift, carry, push, and/or pull up to 50 pounds.