Quality Control Analyst I at Standard BioTools Inc. in Boulder, Colorado

Job Description:

Position Title: Quality Control Analyst I

Location: Boulder - CO

Position Type: Full time

Requisition_ID: 2024-0302

Description:

Would you like to join an innovative team driven by a bold vision – unleashing tools to accelerate breakthroughs in human health?

Would you like to join an innovative team creating technology to power ground-breaking insights in academic, clinical, pharma and biotech research?
It is an extraordinary time for Standard BioTools. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.

At Standard BioTools, we are building a positive culture where our people can do the best work of their careers, informed and influenced by our core behaviors:
•Keep customers front and center in all of our work
•Be accountable and deliver on commitments
•Drive continuous improvement
•Be collaborative and work as one team: fostering communications in a learning, coaching, and helpful environment

We are currently looking for a Quality Control Analyst to perform analysis of raw materials, finished product, stability samples, and R&D materials as part of the quality team. This will include understanding the basics of proteomics and DNA, handing sensitive materials, performing statistical analysis on results, and technical writing to report results as part of supporting multiple departments to achieve a common goal

• Complying with cGMPs, CLIA regulations, SOPs, safety requirements, and all company policies
• Generating and maintaining laboratory data and records in accordance with company policies
• Participate in writing testing proposals, testing components to determine functional reliability, and creating final reports to document and report results.
• Perform laboratory tests applied by the QC laboratory for evaluation of raw materials, components, and finished products.
• Conducting product stability testing and product expiration testing in accordance with defined schedules
• Writing or editing SOPs, work instructions, and other documentation for QC department
• Independently performing and adequately documenting basic investigations for out-of specification or out-of-trend results
• Assisting department management in the execution / implementation of projects or other duties as required
• As appropriate, will cross-train within department or in other departments or job functions to meet production or assay timelines when needed.
• Participates in departmental or cross functional process improvement programs or other projects.

Education: Bachelor’s Degree – major in Chemistry, Biology, or related science

Skills and Experience:

• 1 - 5 years of experience, preferably in the pharmaceutical or medical device industries, with knowledge of cGMP or ISO regulations
• Attention to detail and good documentation practices required.
• Understanding of a variety of laboratory techniques, including HPLC, PCR, aseptic techniques, spectroscopy, buffer and mobile phase preparation, pH, pipetting, biological sample and hazardous material handling
• Demonstrated ability to understand complex problems and devise solutions.
• Ability to prioritize and meet deadlines, proven ability to multi-task effectively.
• Eager to build effective relationships across other departments and working groups.
• Knowledge and experience using LIMS and liquid handling robotics (i.e. Tecan, Beckman, etc.) preferred.
• Strong communication and presentation skills, including technical writing and reporting.
• Proficient in MS Word and PowerPoint, highly proficient in Excel, understanding of statistical analysis.
• Interest in experimental design and analysis, including critical thinking and collaboration.

Work Environment:

• Ability to work in a fast-paced environment.
• Physical Demands / Surroundings – Works in a laboratory setting. The individual will be required to enter production support areas/laboratories while wearing appropriate personal protective equipment such as lab coat, gloves and safety glasses. Note: Potential to work with or in proximity to patient samples (blood, plasma, CSF, and other matrices), including known and suspected infectious material.

05 S - 05 S

PI255342367

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