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Laboratory Assistant II (Fixed-Term: 12 months/FTE 75%)School of Medicine, Stanford, California, United StatesNewResearchPost Date 4 hours agoRequisition # 99482The Sean N. Parker Center for Allergy and Asthma Researchat Stanford University is seeking a 12 month fixed-term/FTE 75% Laboratory Assistant II to support the manufacturing facility with the preparation of Oral Immunotherapy products. The manufacturing facility is located in Mountain View.This position is represented by SEIU Local 2007 and the collective bargaining agreement between the university and SEIU Local 2007 governs the terms and conditions of employment.The anticipated shift is based on the operational needs and can change at any time with notice.Monday-Friday: 8:00 am to 2:30 pm with a 30-minute lunch break.Job Classification Title: Laboratory Assistant IIResponsibilities include:
Responsible for complying with Good Clinical Practices (cGCP) and Good Manufacturing Practices (cGMP) regulations in the manufacturing of materials and investigational products used in Phase I, II, and III clinical trials, in addition to performing associated activities. These include, but are not limited to, the direct manufacture of material and product according to established batch records, accurate weighing of powders and assembly of unit doses, creation and application of product labeling; verification and quality assurance/control of completed materials and product; and complete and accurate documentation of activities where appropriate. Additionally, this includes the oversight, preparation, dispensation, documentation, and management of Oral Food Challenge materials for use in clinical trials to verifying food manufacturing process, weighing of flours and powders used for patient doses of allergen, maintaining appropriate documentations based on respective studies cleanliness of the manufacturing facility, equipment verification, and process validation. Assist with programs regulatory audits and provide necessary reporting and documentation.
Monitor and coordinate shipment of finished materials and product to clinical research sites. This includes, but is not limited to, the tracking and monitoring of site inventory and needs over time; generation of shipment documentation and labeling; direct shipment packing, assembly, and verification; transfer of parcel to shipping servicer; troubleshooting; and chain-of-custody documentation and assurance.
Maintain stock control and inventory of bulk materials used in the production of final materials and products, in addition to maintaining ancillary supplies used in the course of Manufacturing Facility function. These include, but are not limited to, monitoring supply inventory; reordering and tracking supplies from order to receipt; overseeing the transfer of bulk material to appropriate testing laboratories and facilities for testing and analysis; receiving, documenting, and interpreting analyses results; generating Certificates of Analysis; maintaining clean and hygienic work environment per Standard Operating Procedures; maintaining and coordinating the cleaning, servicing, and calibration of Manufacturing Facility equipment.
Assist with regulatory items related to clinical research and interact with clinical research monitors and auditors as needed. This includes, but is not limited to, meeting with and supporting regulatory audits and clinical monitors; providing necessary reporting and documentation to such monitors or regulatory bodies; and providing formal responses and follow-up to inquiries and findings.
DESIRED QUALIFICATIONS:
Strongly prefer applicants with experience working with food allergy patients and/or manufacturing processes.
Familiar with QC principles and acceptable method for complying with the statutory requirements of a manufacturing facility that follows cGMP.
Excellent organizational skills and demonstrated ability to complete detailed work with a minimum of error, troubleshoot unplanned situations and complete duties with limited supervision.
Demonstrated initiative and good judgment.
Demonstrated ability to work well with Stanford colleagues and clients and with external organizations.
Demonstrated commitment to personal responsibility and value for safety, shown through communication of safety concerns and the use and promotion of safe behaviors based on training and lessons learned.
Demonstrated ability to handle confidential and sensitive information (written and verbal) with tact and diplomacy.
Ability to communicate, both verbally and in writing.
Ability to follow standard operating procedures and to prioritize tasks.
Ability to apply HIPAA training in all work interactions (verbal and written).
Understanding of cGMP and manufacturing processes.
Willingness to learn and follow required training.
High school diploma or equivalent and at one year of relevant experience. Additional education including college level laboratory courses desired.
EDUCATION & EXPERIENCE (REQUIRED):
This position requires a minimum of one year of Laboratory Assistant I level or a combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
In addition to the qualifications listed for the Laboratory Glassware Washer, these employees must have demonstrated initiative and good judgment.
Ability to perform work with a minimum of error under general supervision.
Ability to train others in aspects of Lab Assistant work.
PHYSICAL REQUIREMENTS:
Manual dexterity to perform assigned tasks.
Write by hand, sort/file paperwork or parts.
Frequently stand/walk, perform seated work, operate special machines
Occasionally twist/bend/stoop/squat, reach /work above shoulders, light fine grasping.
Lift/carry/push/pull objects that weigh up to 20 pounds.
Rarely help move heavier items (e.g. chairs or lab equipment; packages of supplies; drums containing 2 to 15 gallons, depending on ability.
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 his or her job.WORKING CONDITIONS:
Work occurs in a research environment. Depending on research, Lab Assistants may work in the vicinity of hazardous materials.
Expected to follow all safety requirements and procedures, including wearing appropriate Personal Protective Equipment (PPE) if required.
WORK STANDARDS:
When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.
Interpersonal Skills: Demonstrates the ability to work well with Stanford’s colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide,http://adminguide.stanford.edu/and the appropriate collective bargaining agreement at:https://cardinalatwork.stanford.edu/hr-processes-policies/labor-relations-collective-bargaining
The expected pay range for this position is $27.43 (Step 1) to $33.14 (Step 10) per hour. Placement in the pay range is subject to the applicable collective bargaining agreement.Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position.Why Stanford is for You:Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:
Freedom to grow . We offer career development programs, tuition reimbursement, or course auditing. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
A caring culture . We provide superb retirement plans, generous time-off, and family care resources.
A healthier you . Climb our rock wall or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
Discovery and fun . Stroll through historic sculptures, trails, and museums.
Enviable resources . Enjoy free commuter programs, ridesharing incentives, discounts and more
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.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 his or her job.Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law .Additional Information
Schedule: Part-time
Job Code: 5794
Employee Status: Fixed-Term
Grade: A16
Requisition ID: 99482
Work Arrangement : On Site
