Quality Assurance Specialist I
3 days ago
For Current Gilead Employees and Contractors:
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**:
Essential Job Duties & Responsibilities:
- Performs Quality Assurance tasks that supports GMP-compliant operations in an API manufacturing facility.- Drafts technical documents, such as specifications and operating instructions, based upon information provided by other departments, standard procedures, and quality requirements.- Performs detailed reviews of documentation related to GMP activities.- Routes, tracks and completes documents in the electronic document systems and ensures that entries are accurate and current.- Updates and maintains various databases as needed. Assists with the issuance and maintenance of controlled documents.- Types, scans/copies, distributes/retrieves, and files controlled documents and records as required.- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).- Participates in continuous improvement initiatives based on international regulations and industry best practices.- Prioritizing tasks to ensure the critical tasks are completed on time and meet requirements.- Participates in site inspection readiness and the site internal audit program, including site walkthroughs.
Knowledge, Experience & Skills:
- a MS or MA degree in a scientific area and 0+ years OR- A BS or BA degree in a scientific area and 2+ years OR- High school diploma and minimum 5+ years of relevant experience.- Must be able to think critically and creatively, be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.- Demonstrates excellent communication (verbal and technical writing) skills and strong interpersonal skills.
For Current Gilead Employees and Contractors:
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