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Form of workGrade: F
FTE: 100%
Stanford Cell & Gene Good Manufacturing Practices (GMP) Certificate Program
Be an Employee-in-Training and Earn while you Learn as you START your bright biomedical career. We aim to increase opportunity, access, equity, and inclusion as we develop a skilled entry-level cell and gene therapy manufacturing and quality workforce.
Stanford University is seeking a Quality Assurance Associate (CMQAA1) to support the implementation and maintenance of Quality Assurance processes and procedures consistent with the principles of current Good Manufacturing Practices (GMP) for the Laboratory for Cell and Gene Medicine (LCGM).
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.
Innovations in Cell & Gene Therapy represent some of the most promising advancements in the field of biotechnology today. Behind these extraordinary innovations is a workforce that is expected to grow between 50 and 100 percent in the years to come. LCGM is looking to address this gap by creating a NEW Cell & Gene GMP Certificate Program.
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!
This is a fixed term position of up to 18 months.
Duties include:
- Assist with maintaining and compiling of process related documents to support cGMP (current Good Manufacturing Practice) clinical manufacturing. Support generating procedures by following set guidelines and provide suggestions for issues found in documentation processes.
- Generate and issue documents (e.g. batch records, labels, forms associated with clinical manufacturing)
- Identify, classify, and report deviations associated with processes and/or protocols and provide issue resolutions and process improvements to Product Development/ Manufacturing (PD/MFG) and Quality Control.
- Assist with the development and maintenance of Standard Operating Procedure (SOPs), batch records, raw materials specifications, certificate of analysis, training records etc.
- Perform Quality Assurance activities including but not limited to deviation initiation/review, change control initiation, materials management activities, compiling data , organization and verification of Quality System documents, material kitting, etc.
- Perform real-time observation of activities including proper and timely documentation.
- Provide resolution of Quality Assurance issues/documentation in compliance with LCGM policies, cGMP, and Institutional Review Board (IRB) protocols. Report quality issues internally and to appropriate departments.
- Responsible for compiling, organizing, and storing all documentation related to cGMP regulations including developing and maintaining a system for storing documents.
- Provide support for cGMP compliance audits of vendors, contract manufacturers, contract laboratories and quality systems by preparing and reviewing all documents, tracking timelines, and handling back-office operations during site visits.
- - 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 $71,000 to $84,000..
DESIRED QUALIFICATIONS:
- Must be able to work effectively in a fast-paced environment with cross-functional groups involved in multiple projects and timelines.
- Must be flexible in supporting changing priorities while maintaining a collaborative approach.
- Must be able to work independently with some supervision.
- Bachelor's degree in Biology, Chemistry, or Life Science preferred.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and one year relevant experience or an equivalent combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Knowledge of GMP/ ISO compliance, and quality systems.
Applicable or related experience in a quality-related work in a cell therapy/biotech manufacturing setting
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
Experience with office software and database applications.
Excellent inter-personal skills and customer service focus.
Ability to communicate effectively both orally and in writing
CERTIFICATIONS & LICENSES:
None
PHYSICAL REQUIREMENTS*:
- Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten 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:
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 require working in close proximity to blood borne pathogens.
May at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
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 based on research requirements and business needs.
- Schedule: Full-time
- Job Code: 4955
- Employee Status: Regular
- Grade: F
- Department URL: http://pediatrics.stanford.edu/
- Requisition ID: 98779
- Work Arrangement : On Site
