QC Scientist

Lancesoft; Round Rock (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

Lancesoft is seeking a Scientist (Analytical) in Round Rock, TX, to perform analytical testing of finished products, raw materials, and in-process samples. You will develop methods, solve problems, and support investigations in a GMP/GLP environment.

Responsibilities include writing reports, batch records, and test specifications, and collaborating with a cross-functional team to ensure timely project delivery and adherence to ISO standards.

Qualifications

• BS or MS in chemistry or related life science field is required.
• 2+ years of relevant work experience.
• Knowledge of ISO 9001, ISO 17025 and ISO 17034.
• GLP/GMP and/or ISO environment experience preferred.
• Understanding of quality systems in medical device/pharmaceutical fields.

Responsibilities

• Perform analytical testing of finished products, raw materials, and in-process samples.
• Prepare reports, test specifications, batch records, and documentation.
• Support release testing and technical transfer activities.
• Collaborate with scientists and technicians to complete tests and data review.
• Contribute to investigations, OOS strategies, and process improvements.

Skills

Analytical testing

Data interpretation

Technical writing

Project coordination

Education

BS in Chemistry

MS in Chemistry or life sciences

Tools

HPLC

GC

UV-Vis

RI detector

ELSD/FID detectors

Job description

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, Round Rock Quality and Safety policies.

Purpose of the Position:

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.

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 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.

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.

• 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.