QC Lead Scientist

The Fountain Group; Round Rock (TX); On-site; USD 83,000 - 104,000; Full time

Job summary

The Fountain Group is seeking a QC Lead Scientist for a 12-month on-site assignment in Round Rock, TX.

Responsibilities include analytical testing of finished products and materials, OOS investigations, method development, instrument qualification, and maintaining GMP/GLP compliance while handling hazardous chemicals. Openings: 2.

Qualifications

• BS/MS: 4+ years of related analytical laboratory experience.
• PhD: Prior work experience not required.
• Analytical testing and interpretation of results.
• Analytical method development and validation.
• OOS investigation and root-cause strategies.
• Instrument qualification, calibration, maintenance and troubleshooting.
• GMP/GLP laboratory experience.
• ISO 9001/17025/17034 knowledge.
• Laboratory documentation and regulatory compliance.

Responsibilities

• Perform analytical testing of finished products, raw materials, in-process samples, and custom analytical projects.
• Develop and execute investigational strategies for OOS investigations and prepare OOS reports.
• Lead or participate in analytical method development, validation, and technical studies.
• Perform instrument qualification, calibration, maintenance, troubleshooting, and verification.
• Support process, procedure, and laboratory system improvements.
• Maintain QC laboratory readiness per quality and regulatory requirements.
• Prepare and maintain SOPs, technical reports, OOS documentation, training materials, and analytical records.
• Work with GMP/GLP, ISO standards, safety, and controlled-substance requirements.

Skills

Analytical testing

Method development

OOS investigations

Instrument qualification

GMP/GLP experience

ISO awareness

Documentation

Regulatory compliance

Hazardous chemicals PPE

Education

BS/MS in Chemistry or Life Science

BS/MS: 4+ years lab experience

PhD: no required experience

Job description

QC Lead Scientist
Location: Round Rock, TX
Pay Rate: $40–$50/hour
Duration: 12 months, with potential temp-to-perm conversion
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Work Arrangement: 100% On-site
Openings: 2

Job Description

• Perform analytical testing of finished products, raw materials, in-process samples, and custom analytical projects.
• Develop and execute investigational strategies for Out of Specification (OOS) investigations and prepare OOS reports.
• Lead or participate in analytical method development, validation, and technical studies.
• Perform instrument qualification, calibration, maintenance, troubleshooting, and verification.
• Support process, procedure, and laboratory system improvements.
• Maintain QC laboratory readiness in accordance with applicable quality and regulatory requirements.
• Prepare and maintain SOPs, technical reports, OOS documentation, training materials, and analytical records.
• Perform laboratory activities in compliance with GMP, GLP, ISO, safety, and controlled-substance requirements.
• Work with hazardous chemicals, including flammable solvents, carcinogens, dioxins, and corrosive materials, while following required laboratory PPE procedures.

Education

• BS, MS, or PhD in Chemistry or a related Life Science field.
• BS/MS: 4+ years of related analytical laboratory experience.
• PhD: Prior work experience not required.

Required Skills

• Analytical testing and interpretation of analytical results.
• Analytical method development and validation.
• OOS investigation and root-cause investigation strategies.
• Analytical instrument qualification, calibration, maintenance, and troubleshooting.
• Experience working with finished products, raw materials, and in-process samples.
• GMP and/or GLP laboratory experience.
• Knowledge of ISO 9001, ISO 17025, and ISO 17034 requirements.
• QC documentation, SOPs, analytical reports, and technical documentation.
• Laboratory quality systems and regulatory compliance.
• Experience working with hazardous chemicals and laboratory PPE requirements.

Preferred Skills

• Experience in pharmaceutical, medical device, or clinical laboratory environments.
• Experience supporting ISO-regulated QC laboratories.
• Knowledge of products, applications, and quality systems.
• Experience with controlled-substance laboratory requirements.
• Experience leading technical studies and laboratory process improvements.