Stanford University is seeking a Clinical Manufacturing Quality Assurance Associate II (CMQAA2) 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!

Duties include:

• 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 investigation.
• Provide guidance to Product 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. 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 product/process.
• Ensure raw materials used for manufacturing and testing comply with cGMP requirements and ensure staff are trained as required.
• Collaborate with (PD/MFG and QC) to resolved 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 impact.
• 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 maintained.
• Develop processes that enable routine execution and achievement of product/project timelines and contribute to completion of project milestone.
• 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

DESIRED QUALIFICATIONS:

• Bachelor’s degree in life sciences (e.g. biology, chemistry, etc.).
• 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 collaborative approach.
• Able to work independently with some supervision.
• 3 to 5 years of cGMP experience.
• Experience in product release, investigations and leading one or more of the following specialized areas: materials management, operations and/or quality systems.

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/ ISO compliance and quality systems.
• Working knowledge of federal, state and local regulations, GMP, IND, FDA, and CMC.
• Demonstrated ability of problem-detection and problem-resolution skills.
• Demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
• Must possess excellent verbal and written communication skills

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.

Additional Information

• Schedule: Full-time
• Job Code: 4956
• Employee Status: Regular
• Grade: H
• Department URL: http://pediatrics.stanford.edu/
• Requisition ID: 85105