QA Specialist 1

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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
 

Gilead Sciences, Inc. is a research-based biopharmaceutical 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.

We are looking for a highly motivated Quality Specialist for our QA Call center for product complaint intake team.

Job Description

• Receives product quality complaints and inquiries (typically via phone or fax or email), from pharmacies, distributors, clinical sites, healthcare professionals and patients.

• Documents all incoming complaints into complaint management system timely and notifies other QA specialists for start of investigations.

• Provides acknowledgement letters at the initial complaint receipt and closure letters upon completion of complaint investigations.

• Notifies appropriate organizations for any product replacement requests from the complainants.

• Conducts follow up calls to the reporters as required in support of the complaint investigations including sample retrieval and shipment to appropriate forensic labs for analysis.

• Performs returned sample receipt, storage, and assessment.

• Handles receipt and triage of any reported Safety events to patient safety department and ensures monthly and quarterly reconciliation of complaints and safety events.

• Provides general support to the quality systems group including but not limited to database maintenance and report outputs.

• May participate in cross functional complaint related teams.

• May perform investigation of inquiries and DSCSA alerts (verification, trace requests from authorized trading partners and returns alert handling).

• May perform basic data analysis in support of complaint investigations, trend reports and APQRs.

• Triage medical inquires to medical information and perform monthly reconciliation with medical information.

• Ensure compliance with applicable regulatory requirements with current Good Manufacturing Practices (cGMPs)

• Normally receives general instruction on routine work, detailed instructions on new assignments.

• Performs decommissioning of serialized products for returned complaint samples.

Additional Skills & Qualifications

· Must be able to be comfortable speaking to the customers on phone and document verbatim in the system.

· Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and good documentation p