QA Specialist II
Job Location:
Frederick, MD - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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
Position Summary: The QA Operations Specialist II - Continuous Improvement supports Quality Assurance Operations operational excellence and continuous improvement within a GMP-regulated environment. The role performs assigned support activities while applying structured problem-solving data analysis project coordination and performance monitoring to improve compliance quality efficiency and process reliability. The position partners with cross-functional stakeholders to identify implement and sustain improvements and may support additional QA Operations activities based on business needs.
- Perform QA Operations activities to ensure compliance with GMP regulations company procedures site quality standards and applicable regulatory requirements.
- Review manufacturing laboratory environmental monitoring and quality system documentation for accuracy completeness compliance and adherence to approved procedures.
- Support quality systems activities including deviations investigations CAPAs change controls risk assessments audits inspection readiness and effectiveness monitoring.
- Develop revise and maintain controlled documents including SOPs work instructions forms training materials and quality records.
- Partner with cross-functional teams to identify compliance risks resolve quality issues and support timely escalation and resolution of concerns.
- Support implementation of new products processes systems and workflows by establishing quality requirements controls checkpoints and performance metrics.
- Drive and support continuous improvement initiatives utilizing Lean Six Sigma PDCA A3 Value Stream Mapping and root cause analysis methodologies.
- Collect analyze trend and communicate quality and operational data to identify improvement opportunities and measure effectiveness.
- Develop and maintain dashboards scorecards project trackers action logs risk logs and performance reporting tools.
- Coordinate project activities including schedules meetings agendas action items risk management and follow-up activities.
- Assist with project planning and execution including project charters current-state assessments future-state recommendations implementation plans and benefit tracking.
- Support process improvement implementation and sustainment through standardization effectiveness monitoring and continuous evaluation.
- Partner with Quality Assurance Quality Control Manufacturing MSAT Engineering Materials Management Site Planning and R&D teams on quality and operational improvement initiatives.
- Support inspection readiness and audit preparedness through documentation management metric monitoring visual management and remediation efforts.
- Prepare trend reports quality reviews management presentations and training materials to support operational decision-making.
- Maintain accurate traceable and inspection-ready records while exercising sound judgment and escalating issues when appropriate.
- Bachelors degree with at least 4 years of relevant experience
- OR an associate degree and at least 5 years of relevant experience;
- OR a high school diploma/equivalent and at least 6 years of relevant experience.
- Onsite Monday-Friday
- Experience supporting continuous improvement projects in a GMP-regulated pharmaceutical biotechnology or cell-therapy environment.
- Experience with process mapping Value Stream Mapping PDCA A3 root-cause analysis or Lean/Six Sigma tools.
- Experience creating and maintaining dashboards metrics visual-management systems or project-tracking tools.
- Experience supporting cross-functional projects from planning through implementation and sustainment.
- Lean Six Sigma project management or related training/certification.
- Strong analytical technical writing presentation and stakeholder-coordination skills.
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 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 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 will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Required Experience:
IC
About Company
Kite is dedicated to curing cancer. Learn about the science of cell therapy, our cancer research, and our cancer treatments in the pipeline.
