Quality Control Associate

Overview

Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Quality Control Associate (CMQCA2) to execute, design, develop, evaluate and/or implement quality control assays, processes, and procedures for clinical manufacturing, in accordance with principles of current Good Manufacturing Practice (cGMP) to support phase appropriate clinical investigation(s) for treating patients with incurable diseases. This role will primarily be responsible for performing flow analysis and flow assay process improvements as needed.

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

Full time, 40 hours/week, this role may require extended or have unusual work hours (including weekends, early mornings, and late nights) based on business needs

~6-month (980 hour)

On-site

• 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.

• 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.

• Frequently sit, grasp lightly, use fine hand manipulation, repetitive pipetting, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 pounds.

* Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of the job.

• May require working in close proximity to blood borne pathogens.
• Position may at times require the employee to work…