SomaLogic, Inc. Quality Engineer II in Boulder, Colorado
SomaLogic is a privately-owned biomedical science company that developed a revolutionary proteomics technology capable of measuring thousands of different human proteins in a single small sample. We are now moving towards commercializing the health-related information derived from that technology to help people worldwide proactively manage their health for life. As a part of our commercialization effort, we are seeking a Quality Engineer with experience in reagent development, manufacturing, and validation to join our dedicated team of engineers, scientists, bioinformaticians, statisticians, and software developers to help us realize that vision.
This position will report to the Senior Director, Regulatory & Quality and act as the subject matter expert and principal contributor of SomaLogic’s quality engineering initiatives with regards to reagent products and methods. SomaLogic’s products span a broad range of regulatory and quality requirements across multiple international markets, from IVD (US and International), to CLIA and Lab Developed Tests (LDT), to software as a medical device (SaMD). The individual in this role will be relied upon to ensure the robustness of reagent products and their compliance with new and developing quality standards and regulatory requirements. The level of the role will be commensurate with experience of the selected candidate.
Key Job Responsibilities:
Author and review validation protocols and reports for activities related to reagent development, manufacturing processes, and process equipment.
Determine validation strategy based on acceptable risk-based approach.
Review the quality, validation impact, and completeness of change order requests and change controls for all aspects of reagents and chemistry.
Lead cross-functional team to write Process Failure Mode Effect Analysis (PFMEA) of manufacturing and laboratory operations.
Manage projects with multiple validation deliverables in timely manner.
Perform process risk assessments for Non-Conformance Reports (NCRs). Provide quality input to product disposition.
Provide technical support (subject matter expert) during audits (internal and third-party audits).
Propose, plan and execute improvement projects for the quality department as well as for supported operations and development teams.
Participate in Material Review, Change Control, and Equipment Review board meetings.
Create and maintain key quality metrics for supported departments and own projects.
Conduct reviews of product and manufacturing changes for compliance with applicable regulations including protocols and reports to support regulatory submissions.
Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Bachelor’s degree in a Scientific or Technical field (i.e. Sciences or Engineering);
Advanced degree, CQE, or six sigma certifications preferred
Skills and experience
Minimum of 3 years in a Quality or Operations function within, ideally, In Vitro Diagnostics or else a related field (pharma, or medical device).
Proficient in validation methods and evaluation criteria.
Experience with process validation and equipment qualification is required.
Experience with facilities qualification, cleaning validation and/or analytical method validation is preferred.
Knowledge of manufacturing processes (bulking, filling, and/or synthesis) is preferred.
Experience with change control systems.
Experience with electronic document management systems.
Understanding of basic statistics and acceptance sampling.
Experience with PFMEAs is preferred.
Knowledge of CDRH, and ISO regulations. Experience with CLIA regulations desirable.
Experience with FDA-compliant design control, change control, process control and quality systems for in vitro diagnostics highly desired.
Demonstrated computer skills with word processing, spreadsheets, graphics, and statistical tools in support of preparing technical documentation and change reviews.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner. Strong project management, organizational, and follow-up skills, as well as attention to detail in preparation of materials and their review.
Work is in typical office environment but may require occasional work in a typical laboratory environment with personal protective equipment use required. This position may require up to 10% travel.