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Serán BioScience

Posted 1 month ago

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Quality Control Scientist I or II

Bend, OregonRemoteFull-time

AI Summary

Quality Control Scientist I or II performs routine sample testing in the QC laboratory, adhering to cGMPs and SOPs, analyzes materials, prepares stability studies, and mentors staff while supporting client deliverables.

About this role

Serán BioScience provides custom formulation, process development and clinical manufacturing services for a variety of pharmaceutical clients. Our Quality Control Department is seeking a Quality Control Scientist level I or II who performs and supports sample testing activities in the Quality Control laboratory, upholding GMP practices and timely completion of client deliverables.

Duties and Responsibilities

  • Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies.
  • Performs routine extractions for dissolution, assay, and impurities testing.
  • Performs routine testing using analytical equipment including but not limited to KFC, dissolution apparatus, water activity, FTIR, etc.
  • Conducts appearance testing, raw materials sampling, solution preparation, and pH measurements.
  • Drafts stability tables, sets-up stability studies, logs-in samples and standards.
  • Cleans lab and glassware and disposes of analytical waste appropriately.
  • Participates in process improvement and other non-routine projects.
  • Conducts peer review of routine testing at the discretion of management.
  • Performs hypothesis testing or investigative work for OOS results under management and SME guidance.
  • Trains and mentors staff on established processes and procedures.
  • Demonstrates cross-functional support capabilities with other QC teams.
  • Adheres to consistent and predictable in-person attendance.
  • Responsibilities may increase in scope to align with company initiatives.

    • Required Skills and Abilities

    • Hands-on lab experience.
    • Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company.
    • Follow detailed written and oral instructions.
    • Demonstrated ability to collaborate and work in cross-functional teams.
    • Strong organizational skills and attention to detail.
    • Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption and/or unexpected needs.
    • Strong analytical and problem-solving skills.
    • Accepts feedback from a variety of sources and constructively manages conflict.
    • Ability to prioritize tasks and to keep leadership apprised of performance to timelines.
    • Proficient with Microsoft Office Suite or related software.

    Education and Experience

    All levels: Bachelor’s degree in a scientific discipline or related field.
    For a level I applicant, we are seeking 2 years of dedicated lab experience in addition to the science education. GMP setting experience not required but preferable.
    For a level II applicant, we are seeking 3 years of dedicated lab experience (including 2 years in a GMP setting) in addition to the science education.

    Skills

    Analytical Method ExecutionAppearance TestingData Logging And Sample TrackingDissolution TestingExcel / Microsoft OfficeFTIRGlassware Handling And CleaningHPLCLaboratory Equipment OperationOOS Investigation Under GuidancePeer Review Of TestingPH MeasurementRaw Materials SamplingStability Studies SetupWater Activity Testing

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