QC Lead Scientist

Job Description

Job Summary:

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

Duties and Responsibilities:

• 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 Client and regulatory requirements.
• Maintain the QC Laboratory in a state of audit readiness that includes a clean and organized work environment.
• Adhere to Client quality requirements and perform work in compliance with policies and procedures, including controlled substance requirements.
• Perform Laboratory work in accordance with Client 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.

Experience:

• BS or MS will have 4+ years prior work experience in a related field
• PhD and no prior work experience.
• May have prior work experience in a GLP, GMP and/or ISO environment.

Knowledge, Skills, and Abilities:

• The Lead Scientist has demonstrated knowledge and experience in analytical methods and interpretation of analytical results.
• Knowledge of the ISO 9001, ISO 17025 and ISO 17034 requirements.
• May have knowledge of quality system requirements of the medical device, pharmaceutical and/or clinical industries.
• Excellent verbal and technical writing skills.
• Ability to write procedures, reports, OOS reports, training documents, technical presentations, etc.
• Understanding of Client products, their applications and requirements.
• Understanding of Client 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 Client 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.