Gilead Sciences Inc

QA Specialist II

Gilead Sciences Inc • $92K — $120K *
Frederick, MD 21702In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree with at least 4 years of relevant experience
  • Associate degree with at least 5 years of relevant experience
  • High school diploma with at least 6 years of relevant experience
  • Experience in a GMP-regulated environment, preferably in pharmaceuticals or biotechnology
  • Strong analytical and stakeholder coordination skills

Responsibilities

  • Perform QA Operations to ensure GMP compliance and quality standards.
  • Review various documentation for accuracy and adherence to procedures.
  • Support quality systems activities like audits and investigations.
  • Develop and maintain controlled documents and training materials.
  • Partner with teams to identify compliance risks and resolve quality issues.
  • Drive continuous improvement initiatives using Lean and Six Sigma methodologies.
  • Collect and analyze data to identify improvement opportunities.

Benefits

  • Company-sponsored medical, dental, and vision plans
  • Life insurance
  • Paid time off
  • Potential eligibility for bonuses and stock-based incentives
  • Access to a comprehensive benefits package
Full 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.


The salary range for this position is: $92,820.00 - $120,120.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

About Gilead Sciences Inc

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, they seek to improve the care of patients suffering from life-threatening diseases. Gilead's primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular and respiratory conditions.

Gilead Sciences Inc Careers

Join the vibrant team at Gilead Sciences Inc, a leader in the biopharmaceutical industry known for its innovative approach to healthcare. At Gilead, we are committed to advancing the care of patients around the globe through rigorous science and research.

Work You’ll Do

Embark on a career journey with Gilead Sciences Inc, where job opportunities abound in a variety of fields, from scientific research to marketing and sales. Our team is dedicated to fostering an environment of diversity and inclusion, where every employee can thrive.

Innovate and Lead

At Gilead, innovation is at the core of everything we do. Join us and contribute to our mission of saving lives through advanced treatments and cutting-edge medicine. Our leadership is committed to nurturing professional growth, making Gilead an ideal place for those who aim to lead and innovate in the healthcare industry.

Grow Your Career

Gilead Sciences Inc offers a wealth of career advancement opportunities. With personalized career development programs, employees are encouraged to pursue their professional interests and expand their skills. Whether through on-the-job learning, formal training, or leadership development, we provide the tools necessary for long-term career growth.

Be Part of Our Team

Our team at Gilead Sciences Inc is composed of passionate, curious, and solution-driven professionals. By joining us, you’ll collaborate with some of the brightest minds in the industry. Our culture promotes teamwork and an interdisciplinary approach to problem-solving, making our workplace dynamic and innovative.

Internship and Employment Opportunities

Start your career with Gilead through our internship programs, which offer hands-on experience in biopharmaceutical development and business operations. For seasoned professionals, our employment opportunities span across various disciplines, inviting you to bring your valuable skills to our team.

Benefits and Culture

Gilead Sciences Inc is not only a great place to work but also offers competitive benefits designed to support the health, well-being, and financial security of our employees and their families. From health insurance to retirement plans and wellness programs, we ensure our team members are taken care of.

Networking and Professional Development

We emphasize the importance of networking and professional development within the company. Regular workshops, seminars, and training sessions are held to enhance your skills and knowledge. Additionally, Gilead’s strong emphasis on internal networking allows for cross-departmental collaboration and innovation.

Join Our Hiring Events

Stay connected with Gilead by joining our hiring events and exploring open positions that match your skills and interests. We are always on the lookout for dedicated, creative, and driven team players. Prepare your resume, ace the interview, and take the first step towards a fulfilling career at Gilead Sciences Inc.

Explore Jobs at Gilead Sciences Inc

Discover the exciting career opportunities waiting for you at Gilead Sciences Inc. Visit our careers page to search for open positions, read about our company culture, and learn how you can make a difference in the global healthcare landscape.

Stay Up to Date

Keep informed with the latest company news, career tips, and industry insights—all from the people who work at Gilead Sciences Inc. Subscribe to our job alert emails and personalize your experience to receive updates that align with your career preferences. Join Gilead Sciences Inc today and be part of a team that values innovation, leadership, and a commitment to diversity and employee growth.
Learn more about Gilead Sciences Inc
Size
14,400 employees
Market Cap
$107.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$123 million
Founded
1987
5 Year Trend
-2.1%
Revenue
$24.6 billion
NASDAQ
GILD
* Ladders Estimates

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