Onsite QC Chemist II - Method Development & Validation

Techtrueup; Duluth (GA); On-site; USD 25,000 - 41,000; Full time

Job summary

Techtrueup seeks a Quality Control Chemist II to support analytical chemistry within a regulated manufacturing environment. The role focuses on method development, validation and transfer, and instrument qualification, ensuring compliance and reliability.

You will collaborate with Quality Control, Manufacturing, and Quality Assurance across cross-functional teams to deliver timely analytical results and maintain compliant laboratory systems.

Qualifications

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

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.

Skills

Analytical method development

Instrument qualification

Pharma/regulatory industry experience

GMP/GLP environment experience

Education

Bachelor’s degree in Chemistry

Tools

LabVantage LIMS

Empower 3

Job description

Techtrueup seeks a Quality Control Chemist II to support analytical chemistry within a regulated manufacturing environment. The role focuses on method development, validation and transfer, and instrument qualification, ensuring compliance and reliability.

You will collaborate with Quality Control, Manufacturing, and Quality Assurance across cross-functional teams to deliver timely analytical results and maintain compliant laboratory systems.