Lead Analytical QC Scientist: Investigations & Methods

Lancesoft; Round Rock (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Lancesoft is seeking a QC Lead Scientist to independently lead complex QC activities and provide technical guidance to the team. The role is 100% on-site at Round Rock, TX, and requires strong experience in analytical testing, investigations, and method development.

You will develop investigational strategies for OOS, supervise instrument qualifications, and ensure audit readiness of the QC Laboratory. Strong writing and communication skills are essential for reporting and regulatory compliance.

Qualifications

• BS or MS or PhD in chemistry or life science related field.
• 4+ years prior work experience in a related field; PhD with no prior work experience acceptable.
• Knowledge of ISO 9001, ISO 17025 and ISO 17034 requirements.
• GLP, GMP and/or ISO environment experience preferred.
• Quality system knowledge for medical device/pharmaceutical/clinical industries is a plus.
• Strong analytical methods knowledge and interpretation of results.

Responsibilities

• Perform analytical testing of finished products, raw materials, custom analytical projects, and in-process samples as directed in SOPs.
• Develop and execute investigational strategies in OOS investigations and write OOS reports.
• Lead or participate in method development.
• Lead and participate in analytical method validations and technical studies.
• Perform instrument qualifications and maintenance/troubleshooting of analytical instruments.
• Lead or participate in improvement of processes, procedures and systems.
• Document work in accordance with regulatory requirements.
• Maintain the QC Laboratory in a state of audit readiness with a clean, organized workspace.
• Adhere to quality requirements and operate per policies including controlled substances.
• Perform lab work in compliance with safety policies and procedures.
• Actively promote safety policies in the laboratory.

Skills

Analytical problem solving

Leadership

Technical writing

Communication

Education

BS in Chemistry or life sciences

MS/PhD preferred

Tools

Analytical instruments

Job description

Lancesoft is seeking a QC Lead Scientist to independently lead complex QC activities and provide technical guidance to the team. The role is 100% on-site at Round Rock, TX, and requires strong experience in analytical testing, investigations, and method development.

You will develop investigational strategies for OOS, supervise instrument qualifications, and ensure audit readiness of the QC Laboratory. Strong writing and communication skills are essential for reporting and regulatory compliance.