QA Specialist II
gilead · United States - Maryland - Frederick ·
- Category
- QA
- Experience
- 5+ years
We’re 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. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're 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.
Key Responsibilities:
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.
Basic Qualifications:
Bachelor's degree with at least 4 years of relevant experience
OR
OR an associate degree and at least 5 years of relevant experience;
OR
OR a high school diploma/equivalent and at least 6 years of relevant experience.
Onsite Monday-Friday
Preferred Qualifications:
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:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 . Sign up to follow @KitePharma on Twitter at .
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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 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 contact [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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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.
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.
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:
Please apply via the Internal Career Opportunities portal in Workday.