Sr QC Specialist

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
 

​Job Responsibilities

• Manages tasks and may manage performance of assigned group of staff in the QC department, to accomplish company and departmental objectives.

• Assigns, monitors, and reviews progress and accuracy of work of more junior employees.

• Organizes and prioritizes daily tasks, performs training, writes performance reviews and provides coaching.

• Provides data review, process trending, and procedural updates and provide technical support for validation protocol.

• Writes and executes protocols for the qualification and re-qualification of new and current instrumentation.

• Validates if required improvements to current methods.

• Performs method and equipment validation and training.

• Troubleshoots instruments/methods.

• Reviews facility environmental data for acceptability to Gilead SOPs and policies.

• Reviews or creates process trending charts for QC Laboratory processes.

• Supports the LIMS system to provide QC Laboratory method integration and updates.

• Attends specific project related team meetings and address items pertaining to project as assigned by direct manager.

• Follows technology changes, recommends new technologies, purchase and implement if appropriate.

• Schedules projects to ensure that deadlines are met.

• Follows GMPs and comply with all safety regulations.

• Interacts with vendors of supplies and equipment.

• Performs internal auditing of QC Laboratory areas.

• Approves timecards for more junior employees.

• Represents the business at external forums.

Knowledge & Skills

• Strong working knowledge of GMPs, pharmacopoeia and regulatory requirements for testing and validation pertaining to the pharmaceutical industry.

• Proficient in application of QC principles, concepts, industry practices, and standards

• Project Management and prioritization skills.

• Audit and Investigation Skills, Report Writing Skills.

• Strong verbal, technical writing and interpersonal skills are required.

• Proficiency in Microsoft Office applications and other LIMS and QC software.

Education & Experience

• 7+ years of relevant experience and a BS or BA.

• 5+ years of relevant experience and a MS.

• Prior experience in pharmaceutical industry is preferred.

• Prior experience of managing people is desirable.

 

The salary range for this position is: $123,930.00 - $160,380.00. Gilead 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