Manager Quality Control

Employer
Stanford University
Location
Stanford
Closing date
Jul 14, 2033

Job Details



Manager Quality Control
School of Medicine, Stanford, California, United States

Schedule: Full-time
Job Code: 4950
Employee Status: Regular
Grade: K
Requisition ID: 90286

Stanford University is seeking a Manager Quality Control to oversee analytical, microbial, stability and sample management functions ensuring timely testing and batch release of novel clinical materials following principles of current Good Manufacturing Practice (cGMP) and aligned with the phase of the clinical investigation for treating patients with incurable diseases. This position will work closely with QC Analytical Development group to ensure proper transfer of the methods for routine testing.

Duties include:
  • Manage analytical, microbial, stability and sample management functions to ensure timely testing and batch release. Work closely with Analytical Development group to ensure proper transfer of the methods for routine testing.
  • Be an SME for Microbiological assays, Environmental Monitoring and EM trending program. Represent QC during audits as an SME for QC operations.
  • Extensive technical QC experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment.
  • Lead laboratory investigations related unexpected results (Out Of Specification) and deviations. Manage troubleshooting of laboratory equipment.
  • Lead continuous improvement projects and implement sustainable CA/PAs.
  • Oversee and/or review/approve document revisions related to Quality Control activities.
  • Lead vendor management, Contract laboratory management and ensure timely communication to minimize delay in operation.
  • Working closely with the QC Analytical Development team and Process Development/Manufacturing team to ensure new methods are fit for use for routine testing.
  • Extensive experience in Microbiological assays, compendial test methods and verification/qualification of such methods.
  • May direct and oversee qualification of microbiological assays independently or in collaboration with contract laboratories.
  • Ability to communicate effectively, both verbally and in writing. Ability to manage a team to ensure timely testing. Oversight of laboratory training programs.
  • Demonstrated resolution of complex issues in creative and effective ways
  • Excellent organizational skills and attention to detail.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in related scientific field and 6 years relevant experience; or Master's degree and four years of related experience or an equivalent combination of education and experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
  • Ability to manage a team of QC Analysts working on clinical stage product release in a dynamic environment
  • Be an SME for Microbiological assays, Environmental Monitoring and EM trending program. Represent QC during audits as an SME for QC operations.
  • Extensive technical QC experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment.
  • Experience with performing laboratory investigations related unexpected results (Out Of Specification) and deviations and writing relevant investigation reports. Experience with lean/six sigma principle and implementing sustainable CA/Pas is a plus.
  • Extensive experience in Microbiological assays, compendial test methods and verification/qualification of such methods. Experience with cell/molecular based assays related to cell and gene therapies (Flow Cytometry, qPCR, ddPCR, CFU, etc.) is highly desired.
  • Demonstrated resolution of complex issues in creative and effective ways
  • Excellent organizational skills and attention to detail.


CERTIFICATIONS & LICENSES:

None

PHYSICAL REQUIREMENTS*:

  • Frequently sit, grasp lightly, use fine hand manipulation, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 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.

Additional PHYSICAL REQUIREMENTS: (remove if none)

WORKING CONDITIONS:

  • May require working in close proximity to blood borne pathogens.
  • Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
  • 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 extended or unusual work hours based on research requirements and business needs.
  • 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 occasional local and overnight travel


To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu

Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.







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We are one of Silicon Valley's largest employers - and also one of the most unique. Our mission is to educate future leaders and promote interdisciplinary, world-class research and teaching. This passion makes Stanford an intensely creative, rewarding, and challenging place to work. At the same time, our traditions of respect and collaboration sustain a humane, supportive environment in which to pursue your life and your career. 

At Stanford you'll work with bright, diverse, dedicated people. You'll find encouragement to learn and grow. You'll enjoy excellent benefits and an outstanding environment.

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Campus

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  • Nearly 700 major buildings
  • 97% of undergraduates live on campus

Research

  • 5,300 externally sponsored projects
  • $1.33 billion total budget

Faculty

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  • 21 Nobel laureates are currently members of the Stanford community
  • 5:1 student to faculty ratio

Stanford University is an Equal Employment Opportunity and Affirmative Action Employer and is committed to recruiting and hiring qualified women, minorities, protected veterans and persons with disabilities.

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