Quality Control Chemist II

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 

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.

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

All your information will be kept confidential according to EEO guidelines.