Clinical Manufacturing Quality Control Analyst 2

Job Description

Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Clinical Manufacturing Quality Control Analyst 2 (Quality Control Specialist) to design, develop, evaluate and implement quality control testing, assays and procedures for clinical materials manufacturing consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the phase of the clinical investigation for treating patients with incurable diseases.

LCGM is a GMP multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children’s Hospital (LPCH) and Stanford Health Care (SHC) in developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in Phase I/II clinical trials.

LCGM is a growing, dynamic team who are dedicated to supporting translational medicine and contributing to Stanford Medicine’s mission. We invite you to join our team!

Learn more about our team here: https://med.stanford.edu/lcgm.html .

Duties Include

• 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.
• - Other duties may also be assigned

Responsibilities

Core Duties:

• 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.

Minimum Education And Experience

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.

Knowledge, Skills And Abilities

• 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.