Quality Assurance Analyst 1

🔍 School of Medicine, Stanford, California, United States

📁: Research

📅   : Apr 26, 2024 Post Date

📅   : 103031 Requisition #

Stanford Radiology is committed to providing exceptional patient care by leveraging technology, innovation, and compassion. We also aim to educate and train the next generation of leaders in patient care and research. Our research and development team is working on advanced technologies, including molecular imaging, in-vitro diagnostics, image-guided therapeutics, and informatics to improve precision health. We strive to foster a culture of diversity, inclusion, transparency, and integrity.

At Radiology, we are dedicated to recruiting team members who are enthusiastic about their work, adaptable, and enjoy achieving outcomes. We prioritize providing our staff with the necessary tools to perform their job effectively, assisting them in gaining new skills, and advancing within the organization. We believe in promoting a healthy work-life balance for our team and offer support to help achieve it.

The Cyclotron Radiochemistry Facility of the Radiology Department, School of Medicine at Stanford University is setting up a lab in the newly built CRF Page Mill facility. Equipped with state-of-the-art instruments and talented chemists, its mission is to manufacture precision medicine to help patients fight cancer. We seek an energetic Clinical Manufacturing Quality Assurance Analyst, who shares this vision, to support the development, implementation and maintenance of our quality assurance program.

Duties include*:

Assist with developing, drafting, maintaining, and compiling of 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) and ANDA 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.

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.

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.

WORK STANDARDS:

Interpersonal Skills: Demonstrates the ability to work well with Stanford 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.

The expected pay range for this position is $34.62 to $41.83 per hour.

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.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form.

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.

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.

Additional Information