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Quality Control Associate I

School of Medicine, Stanford, California, United States

New

Research

Post Date 1 day ago

Requisition # 106967

Two(2) positions openings

Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Quality Control Associate I (CMQCA1) to perform various routine quality control testing for Microbiological (endotoxin, mycoplasma, sterility gram stain) testing and sample preparation and biologics (flow cytometry, qPCR, etc.) assays 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.

Duties include:

+ Perform Microbiology Testing (LAL), QC Assays (Flow Cytometry, PCR, Sterility, Endotoxin, etc.) and prepare samples for sterility testing per test procedures. Adhere to requirements of the method and good documentation practices.Document and maintain environmental monitoring data and generate monitoring reports

+ Document performance of analytical methods in order to be consistent with current GMP and documentation practices.

+ Support document revision/creation 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_

_All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels._

_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:

+ Accountable for assigned responsibilities.

+ Abilityto efficiently work in fast paced environment.

+ Able to communicate effectively intra and interdepartmental.

+ Actively participate in multiple projects.

+ Ability to meet 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.

+ 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, while proactively communicating changes in pre-established goals and deadlines.

+ Excellent organizational skills and attention to detail.

+ Excellent verbal and written communication skills.

+ Some knowledge of cGMP, GMP, ICH (International Council for Harmonization), International Organization for Standardization (ISO) requirements, FDA, Ph. Eu, 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:

+ 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, early mornings, and late nights) based on business needs.

Additional Information

+ **Schedule: Full-time**

+ **Job Code: 1021**

+ **Employee Status: Regular**

+ **Grade: F**

+ **Department URL:** **http://pediatrics.stanford.edu/**

+ **Requisition ID: 106967**

+ **Work Arrangement : On Site**