Quality Assurance Specialist
hace 7 días
Gilead Sciences is a leading biopharmaceutical company dedicated to creating innovative treatments for complex diseases. With a strong commitment to improving lives, we strive to push the boundaries of scientific research and development.
We are a dynamic and collaborative team that values diversity, inclusion, and creativity. Our employees are passionate about making a difference and driving progress in the healthcare industry.
About the RoleAs a Quality Assurance Specialist at Gilead Sciences, you will play a critical role in ensuring the quality and safety of our products. This includes performing audits, qualifying and monitoring suppliers, and managing quality agreements.
You will work closely with cross-functional teams to develop and implement quality management systems, and ensure compliance with regulatory requirements.
Key Responsibilities- Perform selection audits, qualify and monitor compliance to qualification requirements.
- Assist in the management of an apheresis and treatment center (ATC) qualification process that will use risk-based tools for qualification, training, monitoring and disqualification.
- Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
- Manage quality agreements with the ATC.
- Assess and approve any changes to apheresis collection module, cell order tracking and order processing systems to assure validated state of the systems is maintained.
- Maintain the monitoring schedule and approved ATC list.
- Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
- Assist in development, implementation and management of ATC management system (Oracle Agile).
- Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
To be successful in this role, you will need:
- A Bachelor's degree in Nursing, biological sciences, nursing, medical technologist or related field.
- Relevant experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems' roles.
- Proficiency in English, Spanish and recommended Portuguese.
- Experience managing external suppliers, blood banks, and plasma centers.
- Medical center or pharmaceutical auditing experience preferred.
- Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred.
- Previous experience in Quality Assurance, preferred.
- Proficient in MS Word, Excel, and Power Point.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
We offer a competitive salary of $120,000 - $180,000 per year, depending on experience, plus a range of benefits including:
- Medical, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Tuition reimbursement program.
- Paid time off and holidays.
- Opportunities for professional growth and development.
This role is based in Europe, with opportunities for international travel up to 50%.
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