Quality Control Expert

Quality Control Expert

Location: Round Rock, TX

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $35.00 $38.00 / 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 Scientist (Analytical) is responsible for performing analytical testing of finished products, raw materials, custom analytical services, and in-process samples. The 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 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.

The purpose of this position is to support Quality Control Release Testing of items manufactured at the site and other assigned projects. Work closely with senior team members on multiple aspects of testing, documentation, and data review to support the release of Certified Reference Materials, Reference Materials, and Analytical Standards to the market. Activities are aligned with ISO 9001, ISO/IEC 17025, and ISO 17034.

Key Responsibilities

• Undertake assigned projects, stability studies, writing of reports, test specifications, and batch records in the QC Laboratory
• Product & Application Development: run analytical methods and stability assessments primarily by HPLC and GC, evaluate manufacturing formulations, support validations, technical transfer, training, and testing
• Follow regulatory, customer, and quality system requirements in product development
• Process results of project work, document methods on project/product design, test specifications, write batch records, test specifications, etc.
• Collaborate and work with other staff (Scientists and Technicians) to complete testing on products
• Other projects as assigned to support innovation and process improvements
• Take responsibility for assigned tasks in consultation with the project team
• Manage tasks and time to meet development schedules
• Participate in training colleagues for technical transfer; work with team and other departments to implement validation and tech transfer requirements
• Develop and expand technical and subject matter expertise in assigned technical areas
• Perform equipment qualifications and maintenance/troubleshooting of analytical systems
• Develop knowledge on critical quality, safety, and delivery requirements
• Contribute to project planning through communication with manager, project manager, and team:

- Identify and communicate resource requirements for specified projects - Provide timely updates and communicate project status to management and the project team - Communicate, in a timely manner, issues related to schedule, planning, and resources that may stall or prevent the execution of the project

Technical Expertise

• Operation of chromatographic instrumentation including HPLC and GC
• Operation of chromatographic detectors including UV-Vis, RI, ELSD, FID, and others
• Develop and expand technical and subject matter expertise in assigned technical areas by seeking out trainings and knowledge-sharing
• Process and project review for certified reference materials by mass balance techniques that may be traceable to primary pharmacopeias

Documentation

• Write reports on results of project work, document methods on project/product design, test specifications, write batch records, test specifications, etc. for transfer to QC
• Maintain lab notebooks, logbooks, batch records, and other documentation

Required Skills

• Demonstrated knowledge and experience in analytical methods and interpretation of analytical results
• Proficiency with chromatography, HPLC, titration, and GC
• Knowledge of ISO 9001, ISO 17025, and ISO 17034 requirements
• Excellent verbal and technical writing skills; ability to write procedures, reports, OOS reports, training documents, technical presentations, etc.
• Understanding of quality system requirements for ISO regulatory 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

Education Requirements

• BS or MS in chemistry or a relevant life science related field (required)

Required Experience

• 2 years of prior work experience in a related field (BS or MS level)

Work Environment / Physical Requirements

• Exposure to a variety of hazardous chemicals
• Required to wear all personal protective equipment as described by applicable procedures, 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 one of the world's largest global leaders 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 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. Recognized by Forbes as one of the World's Best Employers and ranked 15th globally among top biotech and pharmaceutical employers by Science Magazine, the organization employs scientists, engineers, manufacturing specialists, regulatory affairs professionals, clinical operations staff, and business analysts who collaborate to deliver science that changes and extends human life.

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: 26-15829 Industry: Manufacturing & Operations

#LI-Onsite