QC Scientist

Job Description

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 Client, Round Rock Quality and Safety policies.
• 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.

Duties and 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 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.

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, Skills, and Abilities:

• 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 Client products, their applications and requirements.
• Understanding of Client quality system for ISO regulatory requirements.

Environmental conditions:

• Exposure to a variety of hazardous chemicals.
• Required to wear all personal protective equipment as described by Client 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.