Quality Control Expert

the Client•Round Rock, TX

1d•Onsite

About The Position

The Lead Scientist (Analytical) performs analytical testing of finished products, raw materials, custom analytical services, and in-process samples. The role applies technical experience and education to solve problems, optimize and develop processes and methods, and support the development and analysis of new products. It also leads complex QC activities, provides technical guidance to analysts, develops investigational strategies, and participates in Out of Specification (OOS) investigations. Work must be accurate and comply with quality and safety policies. The position conducts analytical analyses in support of catalog, custom, and new products; participates in technical problem-solving and process initiatives; performs laboratory maintenance and housekeeping; and completes equipment calibration, verification, and maintenance with required documentation. The Lead Scientist maintains audit readiness, documents work according to regulatory requirements, and supports departmental goals and quality systems. This is an onsite, 12-month contract in Round Rock, Texas, with potential temp-to-perm conversion depending on business needs. The schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m. The pay rate is $40–$50 per hour. Applicants must be authorized to work for any U.S. employer; visa sponsorship is not available.

Requirements

Bachelor’s, master’s, or Ph.D. in chemistry or a relevant life-science-related field.
For candidates with a bachelor’s or master’s degree, 4 years of prior work experience in a related field is required; no prior work experience is required for Ph.D. candidates.
Demonstrated knowledge and experience in analytical methods and interpretation of analytical results.
Excellent verbal and technical writing skills, including the ability to write procedures, reports, OOS reports, training documents, and technical presentations.
Understanding of products, their applications, and requirements.
Understanding of quality systems for ISO regulatory requirements.
Knowledge of ISO 9001, ISO 17025, and ISO 17034 requirements.
Ability to lead technical investigations, troubleshoot complex analytical issues, and provide technical guidance to other analysts.
Must be authorized to work for any employer in the United States; visa sponsorship or transfer is not available.
Ability to wear required personal protective equipment and work with hazardous chemicals and general processing equipment.

Nice To Haves

Prior work experience in a GLP, GMP, and/or ISO environment.
Knowledge of quality system requirements in the medical device, pharmaceutical, and/or clinical industries.

Responsibilities

Perform analytical testing of finished products, raw materials, custom analytical projects, and in-process samples according to standard operating procedures and methods.
Develop and execute investigational strategies for OOS investigations and write OOS reports.
Lead or participate in analytical method development.
Lead and participate in analytical method validations and technical studies.
Perform instrument qualifications and maintain and troubleshoot analytical instruments.
Lead or participate in improvements to processes, procedures, and systems.
Document work in accordance with regulatory requirements.
Maintain the QC laboratory in an audit-ready condition, including a clean and organized work environment.
Follow quality requirements, policies, and procedures, including controlled substance requirements.
Perform laboratory work according to safety policies and procedures, and actively improve and promote laboratory safety.
Complete laboratory maintenance and housekeeping activities in accordance with safety and quality policies.
Complete equipment calibrations, verifications, and maintenance on schedule with required documentation.
Train on and demonstrate understanding of multiple analytical techniques.
Participate in developing and understanding departmental goals and interdepartmental processes and quality systems.