Supervisor, Quality Control Lab Support
Supervisor, Quality Control Lab Support
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$ 107185 - 138710
1 Vacancy
Job Description
Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet.
Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
Kite is seeking a highly-motivatedindividualto join us as a Supervisor reporting to the Manager Quality Control in Frederick MD. In this role you will be responsible for tasks associated with managing a group responsible for SampleManagement Shipping and LabServicesQC functions and havecross-functionalinteractionwith personnel from other QC groups Quality AssuranceAnalyticalDevelopment Manufacturing and Corporate teams.
The position is primarilyresponsiblefor providing guidance to the QC Lab Support function. This group will operate 7 days a week with an extended overlapping shift structure. You will beresponsiblefor the day-to-day oversight of the QCLab Supportteam during a 40-hour work week.
** SHIFT - Mon- Fri 9am to 6pm **
AdditionalResponsibilities(include but are not limited to):
- Maintain and oversee processes to support sample receipt chain of custody storage and processing for release and stability testing.
- Oversee shipment of samples to internal and external testing labs.
- Supervise the QC Lab Support team and ensure efficient operation of sample logistics in support of QC testing manufacturing and stability programs.
- Review and approve sample-related documentation including chain of custody shipment records logbooks and electronic data entries (e.g. LIMS).
- Complete routine review of records related to sample management including samples reagents materials and retains.
- Hire mentor and develop QC Lab Support staff to support a high-performing scalable team structure.
- Provide coaching performance feedback and career development.
- Manage the QC Lab Support training program.
- Generate Certificates of Analysis (CoAs) for product release.
- Lead or support investigations deviations and CAPAs related to sample handling discrepancies shipping errors or storage excursions.
- Author implement and review changes to controlled documents.
- Participate in audits and inspections as the subject matter expert (SME) for QC Lab Support operations.
- Represent QC Sample Management in cross-functional meetings and provide regular updates during daily and weekly team huddles.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Support and lead initiatives related to Lean Lab and Operational Excellence to enhance efficiency.
- Review and provide input on proposed changes to sample management procedures systems and quality documentation.
- Perform other duties as assigned.
Basic Qualifications:
- MA / MS Degree with 3yearsofQuality Control and/or cGMP operations and/or quality experience OR
- BA/BS Degree with 5yearsofQuality Control and/or cGMP operations and/or quality experience
Preferred Qualifications:
- Demonstrated ability todevelopmotivate andmentorkey employees
- Demonstrated ability to lead a functional area with multiple shifts
- Well versed and experienced in bioanalytical methods and experience in managing a Quality Control laboratory under GMP compliance
- MeaningfulExperience in applying GMP in QC lab in conformance to U.S. EU and ROW standards
- Experience in conducting lab investigations writing deviations implementing CAPA and initiatingchangecontrol
- Ability to effectively negotiate anddevelopcollaborationamongstindividuals
- Excellentinterpersonal verbal and writtencommunication skillsare essential in thiscollaborativeworkenvironment
- Comfortable in a fast-pace small companyenvironmentwith minimal direction and able to adjust workload based on changing priorities.
Does this sound like you If so apply today!
For additional benefits information visit:
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 contact for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION 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. Please apply via the Internal Career Opportunities portal in Workday.
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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma 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:
Required Experience:
Manager
Employment Type
Full-Time
