Quality Control Expert

Quality Control Expert

Location: Round Rock, TX

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 12 months (temp to perm potential depending on business needs)
• Pay Rate: $40.00 $50.00 / Hour (USD)
• Shift / Schedule: Monday Friday, 8:00 AM 5:00 PM
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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 quality and safety policies.

Key Responsibilities

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.
• Demonstrate understanding of interdepartmental 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.

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 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.

Required Skills

• 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 systems for ISO regulatory requirements.
• Knowledge of ISO 9001, ISO 17025, and ISO 17034 requirements.
• Prior work experience in a GLP, GMP, and/or ISO environment (preferred).
• Knowledge of quality system requirements of the medical device, pharmaceutical, and/or clinical industries (preferred).

Education Requirements

• BS, MS, or PhD in Chemistry or a relevant life science related field required.
• BS or MS candidates: minimum 4 years of prior work experience in a related field required.
• PhD candidates: no prior work experience required.

Required Experience

• BS or MS: minimum 4 years of prior work experience in a related field.
• PhD: may qualify with no prior work experience.

Work Environment / Physical Requirements

• Exposure to a variety of hazardous chemicals.
• Required to wear all personal protective equipment (PPE) as prescribed, including 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, carcinogens, dioxins, and corrosives, and general processing equipment.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About the Client

This research-intensive biopharmaceutical company is a global leader in the discovery, development, manufacture, and commercialization of medicines, vaccines, biologics, and animal health products, operating across every continent with annual revenues exceeding $65 billion and approximately 75,000 employees worldwide. Its broad portfolio spans oncology, vaccines, infectious diseases, cardiometabolic health, immunology, neuroscience, and ophthalmology including what is currently the world's best-selling oncology therapy and a leading HPV vaccine. The organization employs scientists, researchers, manufacturing specialists, regulatory affairs professionals, clinical operations staff, and business operations professionals who contribute directly to advancing treatments that improve and extend patient lives globally.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-14435 Industry: Manufacturing & Operations

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