QC Scientist I

LaneHelp; Eugene (OR); On-site; USD 60,000 - 86,000; Full time

Job summary

LaneHelp in Eugene, Oregon seeks a QC Scientist I to perform analytical testing, maintain instruments, and ensure regulatory compliance to support product quality and process control.

You will follow SOPs, apply cGMP/GLP/GDP and quality systems, operate HPLC, ICP-MS, UV-Vis, NMR, and dissolution equipment, and document all results in notebooks and LIMS, with a focus on data integrity and timely batch release support.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, Molecular Biology, or related discipline.
• Minimum 2 years of experience in a quality control laboratory.
• Strong understanding of cGMP, GLP, GDP, and quality management systems.

Responsibilities

• Perform routine and non-routine QC testing according to SOPs.
• Maintain, calibrate and troubleshoot laboratory instruments.
• Ensure compliance with regulatory guidelines and Good Documentation Practices.
• Review data for accuracy, completeness and report deviations.
• Support batch release, stability studies, and method validation as needed.

Skills

Analytical thinking

Attention to detail

Quality mindset

Team collaboration

Documentation skills

Education

Bachelor's degree in Chemistry, Biochemistry, Biology, Molecular Biology, or related scientific discipline

Tools

HPLC

ICP-MS

UV-Vis spectroscopy

NMR

Flow cytometry

Dissolution testing equipment

Job description

Job Title: QC Scientist IJob Description The QC Scientist I supports quality control activities in a laboratory environment by performing analytical testing, maintaining laboratory instruments, and ensuring compliance with regulatory and quality standards. This role applies scientific knowledge and hands-on laboratory skills to generate accurate, reliable data that supports product quality, process control, and regulatory submissions.

The QC Scientist I follows established procedures, documents all work in accordance with Good Documentation Practices, and contributes to a culture of continuous improvement and operational excellence. Responsibilities Perform routine and non-routine quality control testing in accordance with established standard operating procedures (SOPs) and applicable regulatory guidelines.

Apply a strong understanding of cGMP, GLP, GDP, and quality management systems to ensure all testing and documentation meet compliance requirements. Execute analytical methods using laboratory instrumentation such as HPLC, ICP-MS, UV-Vis spectroscopy, NMR, flow cytometry, and dissolution testing equipment, as applicable to assigned projects.

Conduct microbiological testing and aseptic techniques where required, ensuring strict adherence to contamination control practices. Accurately document all testing activities, observations, calculations, and results in laboratory notebooks, electronic systems, and LIMS in accordance with Good Documentation Practices.

Review data for accuracy, completeness, and consistency, and promptly report any deviations, out-of-specification results, or anomalies to appropriate personnel. Perform routine maintenance, calibration, and basic troubleshooting of laboratory equipment to ensure instruments remain in a qualified and reliable state. Follow established schedules and priorities to complete testing within required timelines, supporting batch release, stability studies, and method validation as needed.

Interpret analytical data, apply strong analytical and problem-solving skills to investigate issues, and contribute to root cause analysis and corrective actions. Collaborate with colleagues in quality, manufacturing, and other scientific teams to support cross-functional projects and ensure alignment with quality objectives.

Participate in training on new methods, instruments, and quality procedures, and apply this knowledge to daily work. Support continuous improvement initiatives by identifying opportunities to enhance laboratory workflows, documentation practices, and data integrity. Ensure laboratory activities align with pharmacopeia standards and relevant regulatory requirements where applicable.

Essential Skills Bachelor's degree in Chemistry, Biochemistry, Biology, Molecular Biology, or a related scientific discipline. Minimum 2 years of experience in a quality control laboratory environment. Strong understanding of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and quality management systems.

Hands-on analytical laboratory experience with instrumentation and testing techniques. Experience maintaining, calibrating, and troubleshooting laboratory equipment. Ability to execute testing according to established SOPs and accurately document results. Strong computer skills, including proficiency with Microsoft Office and laboratory software.

Strong analytical and problem-solving abilities. Ability to follow detailed procedures and work with a high level of accuracy and attention to detail. Additional Skills & Qualifications Biotechnolo...