Gilead Sciences Inc

QA Specialist I

Gilead Sciences Inc • $80K — $103K *
Frederick, MD 21702In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) OR BA/BS in a technical discipline with 2+ years of Quality Assurance experience in a GMP environment OR Associates degree with 4+ years of Quality Assurance experience in a GMP environment OR High School diploma with 5+ years of Quality Assurance experience in a GMP environment.
  • Preferred: BS/BA + 2 years experience in a GMP related field within biotechnology or pharmaceutical manufacturing.
  • Working knowledge of GMP conformance to U.S., EU, and ROW standards.
  • Experience with manufacturing investigations, deviations, and CAPA.
  • General knowledge of aseptic manufacturing processes.

Responsibilities

  • Provide QA support on the manufacturing floor and in QC labs.
  • Ensure compliance with process control measures during product manufacturing.
  • Perform apheresis accession of incoming patient material.
  • Authorize shipment of final product.
  • Review and resolve issues in batch-related documentation to facilitate product release.
  • Conduct real-time review of exceptions, CPPs, and CQAs on the manufacturing floor.
  • Gather and report performance metrics for quality assurance.

Benefits

  • Company-sponsored medical, dental, and vision insurance plans.
  • Life insurance coverage.
  • Eligibility for a discretionary annual bonus and stock-based incentives.
  • Paid time off available for employees.
  • Comprehensive benefits package.
Full Job Description
Job Description

We are seeking a highly motivated individual to join us as a Quality Assurance Specialist. In this role you will support the activities of the Quality Assurance department at Kite's Frederick, MD manufacturing site. The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives.

***Shift is Sun-Wed 5:00 pm- 3:30 am***

Responsibilities (included but not limited to):
  • Provide QA support on the floor for production in manufacturing and in the QC labs.
  • Ensure process control measures are in place and followed in product manufacturing.
  • Perform apheresis accession of incoming patient material.
  • Perform shipment authorization of final product.
  • Review batch-related documentation and ensure resolution of issues to release and ship product.
  • Real-time review of exceptions, Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs) on the manufacturing floor.
  • Gather and report metrics to measure performance.
  • Identify and participate in continuous improvement activities.
  • Ensure timely resolution and escalation of issues.
  • Ensure quality records are initiated for deviating events observed on the floor.
  • Ensure approval and timely delivery of final product.
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
  • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
  • Additional duties as assigned.
  • These duties can be delegated to designated deputies of a satisfactory qualification level as needed.


Basic Qualifications:
  • MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) OR
  • BA/BS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR
  • Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 4+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR
  • High School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).


Preferred Qualifications:

  • BS/BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
  • Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards
  • Ability to effectively negotiate and build collaboration amongst individuals
  • Strong teamwork and collaborative skills
  • Experience with manufacturing investigations, deviations, and CAPA.
  • General knowledge of aseptic manufacturing processes.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Strong interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
  • Willingness to think outside of the box and adapt best practices to a small, but growing environment
  • Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.


The salary range for this position is: $80,325.00 - $103,950.00. 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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