QC Lead Scientist

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.

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. Demonstrate understanding of interdepartmental and processes and quality systems. Demonstrate an understanding of and work in accordance with safety policies. Work in accordance with documentation, quality and process policies and procedures.

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.

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. Understanding of products, their applications and requirements. Understanding of quality system for ISO regulatory requirements.

Environmental conditions:

Exposure to a variety of hazardous chemicals. Required to wear all personal protective equipment as described by procedures. This includes gloves, lab coat, safety glasses, respirators, face shields, and other PPE as pre-determined. Will be required to work with chemicals such as flammable solvents, carninogens, dioxins, and corrosives and general processing equipment.