Quality Assurance Associate II
Company: Stanford Medicine
Location: San Ramon
Posted on: May 10, 2022
Pay Grade: H
Stanford University is seeking a Clinical Manufacturing Quality
Assurance Associate II to develop and maintain effective quality
system in accordance with regulations (GMP) and applicable guidance
for the Laboratory for Cell and Gene Medicine (LCGM). The candidate
possess strong technical quality experience who can promote quality
and support best quality assurance practices.
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 early phase 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
- Develop, draft, and compile documents of clinical protocols for
the Investigational New Drug (IND) and Chemistry Manufacturing and
Controls (CMC) sections for submissions to Food and Drug
Administration (FDA), Institutional Review Board (IRB) etc.
- Evaluate compliance of all completed manufacturing (batch
records, forms, etc.) and quality control records (test/analytical
results) to identify deviations. Review deviations and determine if
batch record should be escalated for additional review or
- Provide guidance to Process Development/Manufacturing (PD/MFG)
and Quality Control (QC) to ensure compliance with all applicable
regulations and assist in resolution of issues identified.
- Evaluate and analyze the impact of new regulations to determine
how to implement within unit and make recommendations based on
findings for implementation.
- Oversee Quality Assurance contract manufacturing activities to
ensure required quality standards are maintained based on cGMP
(current Good Manufacturing Practice) regulations.
- Perform independent review of documentation during and
post-execution of cGMP activities and manufacturing campaigns.
Ensure all specifications are met and that applicable requirements
are completed and acceptable.
- Provide guidance and directives regarding remediation
activities required to continue production. Continuously identify
and manage issues to ensure quality control is maintained,
compliant, and the issues have no impact to quality of
- Ensure raw materials used for manufacturing and testing comply
with cGMP requirements and ensure staff are trained as
- Collaborate with PD/MFG and QC to resolve minor and major
deviations and to execute continuous compliance with quality
systems, internal SOPs (Standard Operations Procedures), and
regulatory requirements. Actively participate in the mitigation of
risks by identifying quality issues, determining corrective
actions, minimizing reoccurrence, and evaluating quality
- Generate quality metrics including but not limited to deviation
trends, CAPA effectiveness, EM excursions, product lot acceptance,
confirmed OOS, product complaints rate, annual product review
completion, per defined interval to ensure quality attributes are
- Develop processes that enable routine execution and achievement
of product/project timelines and contribute to completion of
project milestones and grant milestones.
- Participate in cGMP compliance audits of vendors, contract
manufacturers, contract laboratories, and quality systems.
- Ensure equipment qualification have been completed; preventive
maintenance and calibration performed prior to due date.
* - Other duties may also be assigned
- Bachelor's degree in life sciences (e.g. biology, chemistry,
- Ability to effectively work in fast pace environment with cross
functional groups involved in multiple projects and timelines.
- Flexibility to support changing priorities while maintaining
- Able to work independently with some supervision.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and three years relevant experience or an
equivalent combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Working knowledge of GMP/ FACT compliance and quality
- Working knowledge of federal, state and local regulations, GMP,
IND, FDA, and CMC.
- Demonstrated ability of problem-detection and
- Demonstrated organizational skills that have proven results in
the ability to be self-directed while managing multiple
- Must possess excellent verbal and written communication
CERTIFICATIONS & LICENSES:
- 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.
- 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
- May at times require the employee to work with or be in areas
where hazardous materials and/or infectious diseases are
- May be exposed to high voltage electricity, radiation or
electromagnetic fields, lasers, noise > 80dB TWA,
Allergens/Biohazards/Chemicals, confined spaces, working at
- May require extended or unusual work hours based on research
requirements and business needs.
- Schedule: Full-time
- Job Code: 4952
- Employee Status: Regular
- Pay Grade: G
- Requisition ID: 93884 As an organization that receives federal
funding, Stanford University has a COVID-19 vaccination requirement
that will apply to all university employees, including those
working remotely in the United States and applicable
subcontractors. To learn more about COVID policies and guidelines
for Stanford University Staff, please visit
Keywords: Stanford Medicine, San Ramon , Quality Assurance Associate II, Other , San Ramon, California
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