Gilead Sciences Inc

Sr QA Specialist

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

Qualifications

  • 7+ years of GMP experience with a BS/BA, or 5+ years with an MS.
  • Proficient in GMPs and GLPs.
  • Skilled in QA principles and industry practices.
  • Strong analytical and conceptual abilities.
  • Excellent verbal and written communication skills.
  • Familiarity with risk management tools like HACCP and FMEA is advantageous.

Responsibilities

  • Collaborate with cross-functional teams as a Quality Assurance representative.
  • Approve electronic batch records and manufacturing labels.
  • Coordinate the assessment and resolution of discrepancies and deviations.
  • Manage closure of CAPAs and change control requests.
  • Communicate pending lot review issues to management.
  • Ensure compliance with Kite specifications and regulatory guidelines.
  • Support the development and review of SOPs and test methods.

Benefits

  • Company-sponsored medical, dental, vision, and life insurance plans.
  • Eligibility for discretionary annual bonuses and stock-based long-term incentives.
  • Paid time off and flexible work arrangements.
  • Access to employee wellness and development programs.
Full Job Description
Specific Job Responsibilities:
  • Work with the Commercial Manufacturing, Quality Control, Materials Management and
  • Facilities/Engineering departments as a Quality Assurance representative.
  • Coordinate and facilitate Quality Assurance related production and production related activities, including:
  • Approval of electronic batch records and manufacturing labels.
  • Assessment and closure of discrepancies, deviations, CAPAs and change controls requests.
  • Completion of change actions for change controls.
  • Assessment and closure of laboratory investigations.
  • Timely assessment and closure of batch and material hold events.
  • Communicate lot review pending issues to management.
  • Review and disposition of batch manufacturing documentation for timely disposition of final product.
  • Ensure products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.
  • Support development of SOPs and review/approve SOPs to ensure quality objectives are met.
  • Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.
  • Review and approve manufacturing production records.
  • Review and disposition of raw materials.
  • Review and compile all batch related documents into a final product lot disposition package.
  • Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPAs.
  • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
  • Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPAs.
  • Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPAs.
  • Review and disposition raw materials, media/reagents, components, and labels for GMP use.
  • Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies.
  • Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
  • Manage and participate in internal, external and regulatory inspections and audits.
  • Participate in continuous improvement projects.
  • May serve as a team representative on cross-functional projects to support more senior colleagues in the function.
  • Acts as a mentor to junior staff.
  • Provide process training to team, as needed.
  • These duties can be delegated to designated deputies of a satisfactory qualification level as needed.


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.

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 www.kitepharma.com. Sign up to follow [redacted] on Twitter at www.twitter.com/kitepharma.

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

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Gilead Sciences Inc

More Pharmaceuticals & Biotech Jobs

Find similar Sr QA Specialist jobs:

NationwideFrederick, MD