QC Lead Scientist

Job Description

Job Description

Title                             : QC Lead Scientist – Analytical

Location                       : 811 Paloma Drive, Suite A Round Rock TX USA 78665
Duration                       : 12-month contract-to-hire potential
Schedule                      : Monday–Friday, 8:00 AM–5:00 PM
Work Arrangement       : 100% Onsite
Pay Rate                       : $40–$50/hour
Pay                              : Based on experience

Position Overview

The QC Lead Scientist – Analytical will be responsible for performing analytical testing of finished products, raw materials, custom analytical projects, and in-process samples.

This position will use technical expertise to troubleshoot issues, optimize processes, develop and validate analytical methods, support new product development, and participate in Out-of-Specification (OOS) investigations .

The Lead Scientist will ensure all laboratory activities are performed accurately and in compliance with quality, safety, regulatory, and documentation requirements .

Key Responsibilities

• Perform analytical testing of finished products, raw materials, custom projects, and in-process samples according to approved SOPs and analytical methods.
• Lead or participate in OOS investigations , develop investigation strategies, and prepare detailed OOS reports.
• Lead or support analytical method development, validation, and technical studies .
• Perform instrument qualifications, calibrations, maintenance, troubleshooting, and verification activities.
• Identify and implement improvements to laboratory processes, procedures, and quality systems.
• Interpret analytical data and results and provide technical recommendations.
• Maintain accurate laboratory records and documentation in accordance with regulatory and quality requirements.
• Maintain the QC laboratory in a clean, organized, and audit-ready condition.
• Support laboratory equipment maintenance and ensure activities are completed according to schedule.
• Train on and demonstrate proficiency in multiple analytical techniques.
• Prepare technical reports, procedures, training documents, presentations, and other laboratory documentation.
• Collaborate with cross-functional and interdepartmental teams on technical projects and process improvements.
• Follow applicable ISO, GLP, GMP, and quality system requirements .
• Work in compliance with controlled substance requirements and applicable company policies.
• Follow all laboratory safety procedures and actively promote a safe working environment.
• Properly use required PPE when handling hazardous chemicals and operating laboratory equipment.

Basic Qualifications

• Bachelor’s, Master’s, or Ph.D. in Chemistry, Life Sciences, or a related scientific field.
• BS/MS: 4+ years of relevant industry experience.
• Ph.D.: Entry-level candidates may be considered.
• Experience with analytical testing, analytical methods, and interpretation of analytical results.
• Knowledge of ISO 9001, ISO 17025, and ISO 17034 requirements.
• Experience in a GLP, GMP, ISO, pharmaceutical, medical device, or clinical laboratory environment is preferred.
• Strong technical writing and verbal communication skills.
• Ability to write SOPs, technical reports, OOS investigations, training materials, and technical presentations.
• Understanding of quality systems and regulatory requirements.

Work Environment & Safety

• 100% onsite laboratory environment.
• Regular exposure to hazardous chemicals and laboratory processing equipment.
• Experience handling flammable solvents, carcinogens, dioxins, corrosive chemicals, and other hazardous materials .
• Must follow all applicable laboratory safety procedures.
• Required to wear appropriate PPE, including gloves, lab coats, safety glasses, respirators, face shields, and other protective equipment as required.

Ideal Candidate Profile

The ideal candidate will have strong analytical laboratory, QC, method development/validation, OOS investigation, instrumentation, and quality systems experience, along with the ability to independently troubleshoot technical problems and support continuous improvement initiatives.