Quality Control Scientist

Randstad USA; Round Rock (TX); On-site; USD 60,000 - 80,000; Full time

Job summary

MilliporeSigma in Round Rock, TX is seeking a Scientist (Analytical) for a 12-month contract to perform analytical testing of finished products, raw materials, and in-process samples using HPLC and GC, with a focus on accuracy and adherence to ISO quality standards.

You will develop and optimize methods, participate in OOS investigations, assist in method transfer, and support QA in release testing while maintaining thorough lab documentation.

Qualifications

• BS or MS in chemistry or life sciences.
• 2+ years of experience in analytical testing.
• Familiarity with ISO 9001, 17025, 17034.

Responsibilities

• Perform analytical testing of finished products, raw materials, and in-process samples.
• Develop and optimize analytical methods; support validations and tech transfer.
• Document methods, batch records, and test specifications for QC transfer.
• Participate in OOS investigations and ensure compliance with quality systems.

Skills

Analytical testing

Documentation

Quality systems

OOS investigations

Team collaboration

Education

Bachelor's or Master's in chemistry

Tools

HPLC

GC

UV-Vis

RI

ELSD

FID

Job description

***THIS IS A 12-MONTH CONTRACT WITH POSSIBILITY OF EXTENSION***

Schedule: 1st shift 8am-5pm

2nd shift 12pm-9pm

Who We Are:

MilliporeSigma is a leader in the life sciences. We aim to solve the toughest problems in the industry by collaborating with the global scientific community, and through that help increase access to health for people everywhere. We provide scientists and engineers with best-in-class lab materials, technologies, and services. We are dedicated to making research and biotech production simpler, faster, and more successful. At MilliporeSigma, we are with our customers at every step of the drug development process, shaping the possibilities for tomorrow.

Scope of Responsibility:

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 MilliporeSigma, Round Rock Quality and Safety policies.

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

Knowledge and Skills:

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.

Knowledge and Skills:

• The Scientist has 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 MilliporeSigma products, their applications and requirements.
• Understanding of MilliporeSigma quality system for ISO regulatory requirements.

ADDITIONAL LOCAL NEEDS

Environmental conditions:

Exposure to a variety of hazardous chemicals. Required to wear all personal protective equipment as described by MilliporeSigma 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, carcinogens, dioxins, and corrosives and general processing equipment.