Sr. Quality Assurance Specialist
- Employer
- Kite Pharma
- Location
- Santa Monica, CA, United States
- Start date
- Sep 5, 2019
View more
- Discipline
- Clinical, Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach
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Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
We are seeking a highly motivated individual to join us as a Sr. Quality Assurance Specialist. This role will report into the Quality & Compliance R&D Director and you will perform a wide variety of activities to ensure compliance with applicable regulatory requirements and Good Clinical Practice (GCP).
Key Responsibilities (include but are not limited to):
Participate in developing Standard Operating Procedures to ensure quality across internal processes
Create modify and implement clinical trial risk assessment plan.
Keep abreast regulatory developments within or outside the company as well as evolving best practice in compliance control
Support compliance audits as necessary.
Interface with stakeholders to address documentation and compliance issues.
Facilitate and support inspection readiness activities
Develop and provide independent periodic reports to management on overall compliance status
Provide updates at daily and weekly meetings
Minimum 25% travel
Other duties as assigned
Skills/Qualifications:
7+ years of relevant experience in Good Clinical Practice (GCP) environment and a Bachelor's degree in science or related fields or 5+ years of GCP experience and a MS.
Knowledge and experience in quality assurance in a highly regulated environment.
Previous experience of working in a global company
Experience in clinical trials with biologics with cellular therapies a plus
Proficient in MS Word, Excel, Power Point and other applications
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
In-depth knowledge of GxP, QA principles, concepts, industry practices, and standards.
Keen understanding of Computer Systems Validation and ICH Guidelines.
Excellent verbal, written and interpersonal communication skills.
Working knowledge of Risk Management tools
IND123
#LI-ZN1
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactcareers@gilead.comfor assistance.
For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
We are seeking a highly motivated individual to join us as a Sr. Quality Assurance Specialist. This role will report into the Quality & Compliance R&D Director and you will perform a wide variety of activities to ensure compliance with applicable regulatory requirements and Good Clinical Practice (GCP).
Key Responsibilities (include but are not limited to):
Participate in developing Standard Operating Procedures to ensure quality across internal processes
Create modify and implement clinical trial risk assessment plan.
Keep abreast regulatory developments within or outside the company as well as evolving best practice in compliance control
Support compliance audits as necessary.
Interface with stakeholders to address documentation and compliance issues.
Facilitate and support inspection readiness activities
Develop and provide independent periodic reports to management on overall compliance status
Provide updates at daily and weekly meetings
Minimum 25% travel
Other duties as assigned
Skills/Qualifications:
7+ years of relevant experience in Good Clinical Practice (GCP) environment and a Bachelor's degree in science or related fields or 5+ years of GCP experience and a MS.
Knowledge and experience in quality assurance in a highly regulated environment.
Previous experience of working in a global company
Experience in clinical trials with biologics with cellular therapies a plus
Proficient in MS Word, Excel, Power Point and other applications
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
In-depth knowledge of GxP, QA principles, concepts, industry practices, and standards.
Keen understanding of Computer Systems Validation and ICH Guidelines.
Excellent verbal, written and interpersonal communication skills.
Working knowledge of Risk Management tools
IND123
#LI-ZN1
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactcareers@gilead.comfor assistance.
For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
You need to sign in or create an account to save a job.
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