"Clinical Manufacturing Quality Assurance Analyst 1"

Stanford University is seeking a Clinical Manufacturing Quality Assurance Analyst 1 to support the implementation and maintenance of quality assurance processes and procedures for the Laboratory for Cell and Gene Medicine (LCGM).

Duties include:

• Assist with developing, drafting, maintaining, and compiling process related documents to support cGMP (current Good Manufacturing Practice) clinical manufacturing. Support with generating procedures by following set guidelines and provide suggestions for issues found in documentation processes.
• Assist with Investigational New Drug (IND) submissions to the Food and Drug Administration by compiling and providing supporting documentation and answering questions for regulatory affairs during the application process.
• Identify, classify, and report deviations from the process and/or protocols to provide recommendations and process improvements to Product Development/ Manufacturing (PD/MFG) and Quality Control, to ensure compliance with all applicable regulations, and to assist in the resolution of issues. Escalate critical issues within assigned area to senior management team based on severity of the issue.
• In support of clinical trials, review batch records and product dispositions to ensure process is performed per procedure guidelines and address any deviations.
• Assist with the development of standardizing processes for review and maintaining Standard Operating Procedure (SOPs), batch records, raw materials specifications, certificate of analysis, training records etc.
• Execute quality assurance operations required to assess, evaluate, and review processes against cGMPs .Perform real-time observation of activities and issue identification/resolution 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.
• Participate in regulatory, quality and compliance meetings to represent Quality Assurance;
• Responsible for compiling, organizing and storing all documentation related to FDA and cGMP regulations including developing and maintaining a system for storing documents.
• Provide support to 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

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.

LCGM is a growing, dynamic team 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.

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.

Additional PHYSICAL REQUIREMENTS: Occasionally may need to lift, carry, push and pull objects up to 30 pounds.

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.