Quality Control Analytical Scientist II

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, Docu Sign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

The QC Analytical Scientist II will support various Quality Control activities within the AQC department. Key responsibilities are to transfer and execute analytical methods, including raw materials, for use in a CGMP environment in Quality control, both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).

• Drive special projects that require AQC attention/leadership.
• Drive analytical method development and validation of laboratory methodologies and instrumentation. This includes leading analytical/microbiology QC efforts to support the introduction of new product testing, modifying existing laboratory space, plan design new laboratory spaces and working with vendors to purchase new instruments, and the installation and qualification of new instruments.
• Support investigations and manufacturing investigations requiring analytical method support.
• Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.
• Serve on project teams, in a leadership role as needed, which will require substantial interaction and communication with other group functions.
• Upgrading of analytical technologies within an established licensed technology platform.
• Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols
• Support troubleshooting of analytical methods and instruments and support laboratory investigations as needed to provide scientific justification for initial Out of Specification (iOOS), Out of Trend (OOT), and atypical result investigations
• Review and approve laboratory investigations, deviations, CAPAs, and periodic reviews, and other documentation that requires advanced analytical knowledge.
• Ensure all laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
• Responsible for protocol and report generation as well as authoring CMC submission and other technical documents as required. This includes supporting raw material qualification for new products
• Manage and perform assay control and critical reagent qualifications, including monitoring and trending of method performance.
• Support the analysis of QC data using statistical tools to identify trends and set limits for results, including data transcription/entry
• Use sound scientific principles and statistical techniques to solve problems and make recommendations.
• Responsible for deliverables to ensure timelines and milestones are met.
• Support scheduling of AQC and QCM testing (release, execution of protocols, etc.).
• Lead small teams as needed to accomplish tasks.
• Representative for Analytical projects with global and local site functions. Ensure Right First Time (RFT) in the method introduction and instrument qualification process
• Other duties as assigned.

• Performs other related duties and assignments as required

• Excellent technical writing skills and able to write technical documents and reports that meet company and regulatory…