QC Analyst I

Standard BioTools • CO

67d • $54,200 - $63,000

About The Position

Standard BioTools is seeking a QC Analyst to perform analytical testing of raw materials, finished products, stability samples, and R&D materials as part of the quality team. The role involves understanding the basics of proteomics and DNA, handling sensitive materials, performing statistical analysis on results, and technical writing to report results. The position is integral in supporting multiple departments to achieve a common goal, and the level will be commensurate with experience.

Requirements

• Bachelor’s Degree in biology, chemistry, or related science.
• 0 - 5 years of experience in a Quality Control work environment, preferably in the pharmaceutical or medical device industries, working under cGMP or ISO regulations.
• Ability to test raw materials, in-process materials, and finished products.
• Experience with ELISA, microbiology, PCR, or related test methods.
• Experience with HPLC, MS, UV-Vis, and related test methods.
• Ability to devise solutions for complex problems.
• Ability to prioritize and meet deadlines, ability to multi-task effectively.
• Strong communication and presentation skills, including technical writing and reporting.
• Ability to build and maintain effective relationships across departments and working groups.
• Proficient in MS Office applications, highly proficient in Excel.

Responsibilities

• Comply with cGMPs, CLIA regulations, SOPs, safety requirements, and all company policies and procedures.
• Take ownership of and responsibility for analytical testing, including supporting method development or optimization as needed.
• Generate and maintain laboratory data and records in accordance with company policies.
• Conduct product stability testing in accordance with defined schedule (per protocol).
• Perform functional analysis of material to determine binding efficiency, specificity, and other parameters as required.
• Conduct analytical analysis of material to determine identity, purity, conformance to release specifications and other testing parameters.
• Independently perform and adequately document basic investigations for out-of-specification or out-of-trend results.
• Assist or lead the execution/implementation of larger projects, including revising/improving test methods, SOP revisions, process improvement projects, etc.
• Cross-train in other departments or job functions to meet production or assay timelines when needed.
• Participate in departmental or cross-functional projects.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees