Stanford GMP Facility: Laboratory for Cell and Gene Medicine · 1 day ago
Quality Control Associate - Temporary
Palo Alto, CA
Full-time
Onsite
Entry, Mid Level
$40/hr - $43/hr
2+ years expStanford Laboratory for Cell and Gene Medicine is seeking a Quality Control Associate to execute and implement quality control assays and processes for clinical manufacturing. The role involves performing complex testing, documenting procedures, and managing supplies to ensure compliance with cGMP standards.
Biotechnology
Hiring Manager
Danielle Osburg
Responsibilities
Perform increasingly complex chemical, biochemical, biological and/or microbiological testing, assays and procedures related to quality control (QC), which constitute the quality, safety and efficacy of all analytical methods for clinical materials manufactured at Laboratory for Cell and Gene Medicine (LCGM)
Perform tests related to assays; collect, interpret, analyze and report data related to test results including investigation of out-of-specification and/or non-conforming test results
Document QC related test methods, Standard Operating Procedures (SOPs), and instructions to ensure consistency with cGMP and documentation practices
Manage supplies related to clinical materials manufacturing. Create selection criteria, justification and qualification of raw materials. Responsible for examining and documenting materials used in clinical materials manufacturing, consistent with defined, relevant quality standards and cGMP
Perform complex analysis, monitor and trouble-shoot pertinent equipment (e.g., flow cytometers, hematologic analyzers)
Investigate out-of-specification and/or non-conforming test results. Initiate, investigate as appropriate, and prepare deviation reports for SOPs and test methods with input from supervisor in order to implement prevention or corrective actions
Qualification
Required
Bachelor's degree in related scientific field and two years of related experience, or Master's degree, or an equivalent combination of education and relevant work experience
Applicable or related experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment
Strong technical skills and experience with testing QC methods and concepts
Good understanding of cGMP or International Organization for Standardization (ISO) requirements, quality systems
Strong team-oriented, interpersonal skills and collaborative work style
Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
Excellent organizational skills and attention to detail
Excellent verbal and written communication skills
Preferred
Ability to effectively work in fast-paced environment with cross functional groups involved in multiple projects and timelines
Flexibility to support changing priorities while maintaining collaborative approach and cGMP compliance
Able to work independently with some supervision, propose recommendations and solutions regarding development and execution of QC assays
3-5 years cGMP experience
Experience with Cell Culture activities, Flow Cytometry, qPCR, Sterility testing, and/or Environmental Monitoring activities
Company
Stanford GMP Facility: Laboratory for Cell and Gene Medicine
Stanford’s Good Manufacturing Practice (GMP) Facility: Laboratory for Cell & Gene Medicine’s (LCGM) mission is to develop innovative platforms for manufacturing cell and gene therapy products enabling Stanford investigators and Industry partners to bridge the bench to bedside gap for treating patients with large unmet medical needs.
51-200 employees
H1B Sponsorship
Stanford GMP Facility: Laboratory for Cell and Gene Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (551)
2024 (499)
2023 (472)
2022 (390)
2021 (336)
2020 (260)
Funding
Current Stage
Growth StageCompany data provided by crunchbase