QA Specialist II

Location
Foster City, CA
Posted
Nov 25, 2021
Ref
2663882
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
QA Specialist II
Netherlands - Hoofddorp

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible



Quality Specialist II

Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

Kite is seeking a highly motivated individual to join us as QA Specialist II. This individual will work cross functionally to assist with the management of product complaints and post-marketing quality reporting programs for Kite's cell therapy products. This position will report into the Director of Product and Distribution Quality, and be located at Hoofddorp, Netherlands.

Responsibilities (include but are not limited to):
  • Owns product complaint records for Kite's commercial and investigational products.
  • Interfaces with external customers and internal team members to facilitate resolution of complaint-related issues.
  • Supports maintenance of the product complaints module in Kite's quality management system.
  • Generates product complaint metrics for management review.
  • Performs reconciliation activities between product complaint and global safety databases.
  • Generates aggregate reports for post-marketing quality and safety reporting.
  • Support global initiatives to enhance the Product Complaints program.
  • Supports evaluation regional requirements for product complaints to support new product launches.
  • Own quality system records (e.g. deviations, CAPA) on behalf of the department.
  • Supports data review activities for product complaints section of the Annual Product Review.
  • Support inspection readiness plans and participate during compliance audits and regulatory inspections on product complaint topics, as needed.
  • Participates in the development, implementation, and maintenance to optimize department procedures; writes and implements controlled documents, as needed.
  • Perform other duties as required to fulfill department and business needs.


Requirements:
  • 4+ years of relevant experience in a GMP environment related field and a BS or BA.
  • 2+ years of relevant experience and a MS.
  • Prior experience in pharmaceutical industry, cell therapy, biologics, blood/human tissue, or vaccines experience preferred.
  • Experience generating metrics preferred.
  • Demonstrates good technical writing, critical thinking, and problem-solving skills.
  • Demonstrates working knowledge of current GMPs, quality assurance systems, methods, and procedures.
  • Demonstrates knowledge of FDA, EMEA and ROW standards, quality systems and complaint handling.
  • Demonstrates basic knowledge of root cause analysis tools used for identifying and correcting deviations.
  • Previous experience supporting regulatory agency audits, preferred.
  • Proficient in MS Word, Excel, and Power Point
  • Demonstrates good interpersonal, verbal and written communication skills, which are essential in this collaborative work environment.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.


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 @KitePharma on Twitter at www.twitter.com/kitepharma.

Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:
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