Quality Control Scientist

Integrated Resources, Inc ( IRI ); Round Rock (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

Integrated Resources, Inc ( IRI ) is seeking a Scientist (Analytical) for a 12-month assignment with potential temp-to-perm. Position includes 8am-5pm, with potential shift to 12pm-9pm in Round Rock, TX.

Requires chromatography experience, HPLC and GC, and 2+ years in the field. Responsibilities include performing analytical testing, developing methods, writing reports, and supporting QC release testing in a regulated environment aligned with ISO standards.

Qualifications

• BS or MS in chemistry or life sciences related field.
• 2+ years of industry experience in analytical testing.
• Knowledge of ISO 9001, ISO 17025 and ISO 17034 requirements.
• May have GLP/GMP/ISO environment experience.

Responsibilities

• Perform analytical testing of finished products, raw materials, and in-process samples using HPLC and GC.
• Develop investigational strategies and participate in OOS investigations.
• Write reports, test specifications, batch records and document results for QC transfer.
• Support Quality Control Release Testing and align activities with ISO standards and client requirements.
• Collaborate with scientists and technicians to complete testing and data review.

Skills

Chromatography

HPLC

GC

Education

BS or MS in chemistry

Job description

Duration: 12 months, temp to perm potential

Monday-Friday: 8am-5pm may go to 2nd shift at a later date. shift not approved yet. 12pm-9pm

2 positions are still needing to be filled!!

Must have chromatography, HPLC and GC

2+ years of industry experience

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 Client, Round Rock Quality and Safety policies.

Purpose of the Position: Support Quality Control Release Testing of items manufactured at the Client 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.

Essential Job Functions:

• 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 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 though 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.

BASIC QUALIFICATIONS

Education:

• BS or MS in chemistry or relevant life science related field.

Experience:

• BS or MS will have 2+ years prior work experience in a related field.
• 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.