Grade: F
FTE: 100%

Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Quality Control Associate I to perform various quality control testing, assays and procedures supporting clinical product 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!

Duties include:

• Perform chemical, biochemical, biological and/or microbiological testing, assays and procedures related to quality control (QC) by following Standard Operating Procedures (SOPs) in order to obtain results that allow for release of patient product(s). 
• Document performance of analytical methods in order to be consistent with current GMP and documentation practices.
• Support creation of analytical method protocols and reports to support method development, method qualification, stability study, and assay optimization in collaboration with PI and QC project lead. Adhere to cGMP compliance requirements to maintain inspection-ready state.
• Collect, interpret and perform basic analyses and reporting of data from test results. Recommend modifications for optimization or clarification of test procedures, protocols, and assays in collaboration with quality control, quality systems management, Principal Investigator (PI) and project team. 
• Manage, maintain, monitor, and order QC raw materials and supplies
• Monitor and troubleshoot pertinent equipment; Ensure equipment qualification, preventive maintenance, and calibration are performed per requirement and by due date. Coordinate equipment implementation for use and decommissioning activities.
• Participate in the investigation of out-of-specification and/or non-conforming test results. 
• Prepare deviation reports per SOPs with input and oversight from supervisor. Implement prevention or corrective actions based on supervisor feedback.
• Participate in the development and maintenance of QC related SOPs, test procedures, training records, and other QC-related documentation.
• Perform QC Support tasks – e.g. equipment maintenance, tracking of reagent and sample inventory, organization of the lab, checking to ensure removal of expired media performed, etc.
• Coordinate the timely shipment of samples to contract laboratory for testing (e.g. ship samples such as environmental monitoring plates for growth promotion, speciation and product sample).

Other duties may also be assigned

DESIRED QUALIFICATIONS:

• Ability to effectively work in fast pace environment with cross functional groups involved in multiple projects and timelines.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor’s degree in relevant scientific discipline or other appropriate specialty (such as Chemistry, Life Sciences, Engineering) and one year related experience or an equivalent combination of education and relevant work experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Applicable or related experience in a laboratory, preferably a clinically related laboratory or demonstrated excellence in laboratory skills and methods.
• Strong technical skills and some experience with testing QC methods and concepts.
• Some knowledge 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.

PHYSICAL REQUIREMENTS*:

• 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.

WORKING CONDITIONS:

• May require working in close proximity to blood borne pathogens.
• Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
• Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.
• May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals, confined spaces, working at heights

May require extended or unusual work hours (including weekends) based on research requirements and business needs.

Additional Information

• Schedule: Full-time
• Job Code: 4948
• Employee Status: Regular
• Grade: F
• Department URL: http://pediatrics.stanford.edu/