Quality Control Chemist II

Fusion Life Sciences; Johns (WV, AL); On-site; USD 75,000 - 105,000; Full time

Job summary

Fusion Life Sciences is seeking a Quality Control Chemist II to support analytical chemistry in a regulated manufacturing setting. You will develop and validate methods, qualify instruments, and troubleshoot laboratory systems to ensure compliant, reliable results.

The role collaborates with QC, Manufacturing, and QA, and requires hands-on experience in method development, validation, and instrument qualification within a GMP/GLP-regulated environment.

Qualifications

• Bachelor's degree in Chemistry or related field is required.
• Experience with analytical method validation and instrument qualification.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Develop, optimize and improve analytical test methods for lab and manufacturing needs.
• Execute analytical method validations, transfers and periodic reviews per procedures.
• Support method transfers between internal sites and external suppliers.
• Perform compendial assessments and evaluate changes to requirements.
• Execute instrument qualifications and lifecycle activities; provide troubleshooting.
• Lead complex technical projects and drive timely delivery.
• Support investigations, CAPA and technical documentation review.
• Collaborate with cross-functional teams to meet timelines and quality.

Skills

Analytical method development

Analytical method validation

Instrument qualification

Cross-functional collaboration

Regulated environment

Education

Bachelor's degree in Chemistry or related field

Master's or Ph.D. preferred

Tools

LabVantage LIMS

Empower 3

Microsoft Office

Job description

Job Title: Quality Control Chemist II

Location: Johns Creek, GA Onsite

Duration: 12 months, with potential for extension

Work Schedule: Monday Friday, 8:00 AM 5:00 PM (40 hours/week)

Interview Process: Two rounds Phone Interview and Panel Interview

Position Summary

We are seeking an experienced Quality Control Chemist II to support analytical chemistry activities within a regulated manufacturing environment. The successful candidate will be responsible for analytical method development, validation and transfer, instrument qualification, laboratory troubleshooting, and technical investigations.

This role will work closely with Quality Control, Manufacturing, Quality Assurance, and other cross-functional teams to ensure analytical methods and laboratory systems remain compliant, reliable, and fit for intended use.

Key Responsibilities

• Develop, optimize, and improve analytical test methods to support laboratory and manufacturing requirements.
• Execute analytical method validations, method transfers, and periodic method reviews in accordance with applicable procedures and regulatory requirements.
• Support method transfers between internal sites and external suppliers.
• Perform compendial assessments and evaluate changes to applicable compendial requirements.
• Execute and support analytical instrument qualifications, periodic validation reviews, and instrument lifecycle activities.
• Lead and manage complex technical projects, including developing project plans, resolving technical challenges, and making sound technical decisions.
• Provide technical troubleshooting and support for analytical instruments, methods, and laboratory processes.
• Support laboratory investigations, deviations, root-cause analysis, and corrective and preventive actions (CAPA).
• Prepare and review technical documentation, protocols, reports, and other quality-related records.
• Collaborate with cross-functional teams to ensure analytical activities are completed within established timelines and quality requirements.

Top 3 Must-Have Qualifications

1. Strong experience in analytical method development and validation
2. Hands-on experience with analytical instrument qualification
3. Industry experience in pharmaceutical, medical device, or other highly regulated environments

Basic Qualifications

• Bachelor's degree in Chemistry or a related scientific field.
• Demonstrated experience with analytical method validation and instrument qualification.
• Strong computer skills, including proficiency with Microsoft Office Suite.
• Excellent written and verbal communication skills.
• Strong analytical, troubleshooting, and problem-solving abilities.
• Ability to manage multiple priorities and work effectively in a cross-functional, regulated environment.

Preferred Qualifications

• Master's or Ph.D. in Chemistry or a related scientific discipline.
• Experience with LabVantage LIMS or a similar Laboratory Information Management System (LIMS).
• Experience with Empower 3 or a similar chromatography/data acquisition system.
• Experience supporting laboratory investigations, CAPA, and analytical lifecycle management.
• Experience working in a GMP/GLP-regulated laboratory environment.

Ideal Candidate Profile

The ideal candidate will be a hands-on analytical chemistry professional with strong experience in method development/validation, instrument qualification, and laboratory troubleshooting, preferably within the pharmaceutical or medical device industry. The candidate should be comfortable working independently on complex technical projects while collaborating effectively with cross-functional teams.