QC Lead Scienist

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

Title: QC Lead Scienist Mon-Fri 8am-5pm

The Lead position requires a higher level of technical experience and the ability to independently lead complex QC activities and provide technical guidance to the team. Look for demonstrated experience leading technical investigations, troubleshooting complex analytical issues, and providing technical guidance to other analysts.

100% on-site

Scope of Responsibility

The Lead Scientist (Analytical) is responsible for performing analytical testing of finished products, raw materials, custom analytical services, and in-process samples. The Lead Scientist will use their experience and education to solve problems, optimize processes, develop new processes and methods, and assist in the development and analysis of new products. The Lead Scientist will also develop investigational strategies and participate in Out of Specification (OOS) investigations. All work is to be performed accurately and in compliance with, Round Rock Quality and Safety policies.

Purpose of the Position

Conduct work in a professional manner. Undertake an expanding range of analytical analyses in support of catalog, custom and new products. Lead or participate in technical problem solving, implementation of new processes and initiatives. Complete laboratory maintenance and housekeeping activities efficiently and in accordance with safety and quality policies and procedures. Complete laboratory equipment calibrations, verifications and maintenance activities on schedule with required documentation. Train on and demonstrate understanding of multiple analytical techniques. Participate in development of and demonstrate understanding of departmental goals. Work in accordance with documentation, quality and process policies and procedures.

Essential Job Functions

• Perform analytical testing of finished products, raw materials, custom analytical projects, and in-process samples as directed in standard operating procedures and methods.
• 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 and regulatory requirements.
• Maintain the QC Laboratory in a state of audit readiness that includes a clean and organized work environment.
• Adhere to quality requirements and perform work in compliance with policies and procedures, including controlled substance requirements.
• Perform Laboratory work in accordance with safety policies and procedures.
• Actively improve and promote safety policies in the laboratory.

BASIC QUALIFICATIONS

• Education: BS or MS or PhD in chemistry or relevant life science related field.
• Knowledge and Skills: Experience: BS or MS will have 4+ years prior work experience in a related field PhD and no prior work experience.
• Knowledge of the ISO 9001, ISO 17025 and ISO 17034 requirements.
• May have prior work experience in a GLP, GMP and/or ISO environment.
• May have knowledge of quality system requirements of the medical device, pharmaceutical and/or clinical industries.
• Knowledge and Skills: The Lead Scientist has demonstrated knowledge and experience in analytical methods and interpretation of analytical results.
• Excellent verbal and technical writing skills.
• Ability to write procedures, reports, OOS reports, training documents, technical presentations, etc.
• carninogens, dioxins, and corrosives and general processing equipment.