Gilead Sciences Inc

Sr QA Specialist

Gilead Sciences Inc • $123K — $160K *
Frederick, MD 21702In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 7+ years of relevant experience in a GMP environment with a BS/BA or 5+ years with an MS.
  • Proficiency in GMPs and/or GLPs.
  • Strong understanding of QA principles and practices.
  • Demonstrated analytical and conceptual skills.
  • Excellent verbal communication, technical writing, and interpersonal skills.

Responsibilities

  • Analyze complex issues requiring in-depth assessments and consider various factors.
  • Exercise judgment to determine actions independently within set procedures.
  • Mentor junior QA staff members.
  • Manage daily workflow for the QA Tech services team.
  • Develop and maintain processes to ensure compliance with GMPs and GLPs.
  • Lead investigations and CAPA recommendations related to products.
  • Provide QA oversight for deviations and investigations.

Benefits

  • Company-sponsored medical, dental, vision, and life insurance plans.
  • Eligible for discretionary bonuses and stock-based long-term incentives.
  • Paid time off and additional employee benefits.
Full Job Description
Job Description

This position requires:
  • The ability to work on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences.
  • Exercises judgment to determine appropriate action with minimal supervision.
  • Ability to handle pressure and fast decision making.


Responsibilities (included but not limited to):
  • Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences.
  • Exercises judgment within established procedures and practices to determine appropriate action with minimal supervision.
  • Act as a mentor to QA junior staff.
  • Manages the daily workflow of the QA Tech services team.
  • Develops and Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Conducts or acts as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products, and performs QA review and approval of complex deviations and CAPAs.
  • Provide QA oversight to deviations, OOS investigations, Laboratory Investigations, CAPAs, Effectiveness Checks and Change Controls.
  • Knowledgeable in Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
  • Support the development of Risk Management documents using tools such Failure Mode Effects Analysis (FMEA), etc.
  • Uses/Develops KPI's to identify and solve problems within the quality process.
  • Identifies deviations from approved procedures and processes, evaluates impact assessments and develops solutions for complex problems.
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
  • Assists with external audits/inspection processes as required, and acts as an SME for QA procedures and processes during inspections and audits, supporting implementation of corrective actions as agreed.
  • Interfaces with external stakeholders to address documentation and compliance issues.
  • Leads QA projects or contributes to cross functional projects using Lean concepts. Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences. Provides support to incoming escalations from various stakeholders, ensuring all immediate actions are taken and a path forward established.
  • These duties can be delegated to designated deputies of a satisfactory qualification level as needed. Additional duties as assigned.


Knowledge:
  • Proficient in GMPs and/or GLPs.
  • Proficient in application of QA principles, concepts, industry practices, and standards.
  • Demonstrates ability to effectively manage multiple projects/priorities.
  • Has proven analytical and conceptual skills.
  • Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
  • Demonstrates excellent verbal communication, technical writing and interpersonal skills.
  • Demonstrates working knowledge and good proficiency in Microsoft Office applications.
  • Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
  • Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.


Basic Qualifications:
  • 7+ years of relevant experience in a GMP environment related field and a BS/BA.

OR
  • 5+ years of relevant experience and a MS.


The salary range for this position is: $123,930.00 - $160,380.00. 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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