QC Associate

QC Associate Stanford University - 4.2 Stanford, CA Job Details Full-time $36.73 - $42.50 an hour 6 hours ago Qualifications Microsoft Word Microsoft Excel GLP Presentation software GMP ICH guidelines Laboratory compliance Laboratory quality control Quality standards in production Excel data analysis Full Job Description Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Quality Control Associate (QC1). This position will participate in analytical development projects in collaboration with research teams and other cross-functional teams to evaluate, develop and design QC assays, including complex chemical, biochemical, biological and/or microbiological testing. The role will be responsible for supporting/leading testing samples, generating SOPs compliant with GMP standards, conducting studies and training for assay tech transfer. Support testing for clinical manufacturing product release is required when needed. 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:

Support assay development and optimization; Support PD-AD routine testing for preclinical projects; Support the assay qualification/verification/validation/comparability studies. Independently perform complex assays, including flow cytometry, qPCR, ddPCR, potency assays, endotoxin, mycoplasma, cell count and viability per ICH/ISO/USP/Ph. Eur. requirements. Support QC product release testing when needed. Training QC staff for assays and other lab activities. Document execution of test methods according to test procedure(s) per cGMP, GLP, and GDP requirements. Present data internally to LCGM and externally when needed. Perform periodic reviews and any necessary updates/revisions to existing methods and procedures. Trouble-shoot for equipment, ensure instruments are compliant with GMP requirements before testing. Perform and support quality records (deviations, change controls, CAPA's, OOS) associated with QC tests, activities, or quality processes. 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. - Other duties may also be assigned Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. The pay range for this position working in the California Bay area is $36.73 to $42.50 hourly.

DESIRED QUALIFICATIONS

Ability to effectively work in fast-paced environment with cross functional groups involved in multiple projects and timelines. Flexibility to support changing priorities. 0-1 years lab experience in a research setting, preferably have GMP/GLP experience. Experience in Flow Cytometry, cell culture, qPCR, ddPCR, immuno-assay. Experience in assay design and optimization is preferred.

EDUCATION & EXPERIENCE

(REQUIRED): Bachelor's degree in relevant scientific discipline or other appropriate specialty (such as Chemistry, Life Sciences, Biochemical Engineering, or Engineering) and 0-1 years' experience or an equivalent combination of education and relevant work experience.

KNOWLEDGE, SKILLS AND ABILITIES

(REQUIRED): Experience in laboratory, include but not limited to clinical testing, microbiology testing, hematology, blood banking, immunology, sequencing lab or other QC laboratory, preferably in cGMP environment. Strong data analysis and documentation skills, proficient in Microsoft Excel, Word and Power Point. Strong team-oriented, interpersonal skills and collaborative work style. Ability to independently manage own workload with supervisor's guidance. Excellent organizational skills and attention to detail. Excellent verbal and written communication skills. Good understanding of cGMP, International Organization for Standardization (ISO), USP, ICH guidelines and requirements for cell and gene therapy industry, quality control, testing lab and quality systems.

CERTIFICATIONS & LICENSES

None

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

This position requires working in a Biosafety Level 2+ Lab for >4 days/week. It is a full-time position (40 hrs/week). 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.