Quality Control Specialist III

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

AtGileadour pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to a QC Specialist III at Gilead you will support Quality Control laboratory operations through the administration enhancement integration and continuous improvement of QC computerized systems and digital solutions. You will also serve as a technical resource for laboratory informatics instrumentation software data analytics system lifecycle management and digital transformation initiatives. This role collaborates cross-functionally to implement innovative technologies that improve data integrity compliance operational efficiency and laboratory productivity in a GMP-regulated environment.

This is a site-based position (Monday- Friday) in La Verne CA.

Specific Job Responsibilities:

• Provide technical troubleshooting and support for laboratory instrumentation and computerized systems.
• Identify process improvement opportunities and recommend solutions to enhance performance compliance and user experience.
• Interact with vendors to evaluate technologies resolve technical issues and support implementation activities.
• Monitor industry trends emerging technologies and best practices related to laboratory digitalization and QC informatics.
• Support computerized system validation activities including URS risk assessments test protocols reports and lifecycle documentation.
• Ensure systems remain compliant with applicable regulatory and data integrity requirements.
• Participate in change controls deviations CAPAs periodic reviews and audits.
• Support qualification and requalification activities for laboratory instrumentation and computerized systems.
• Partner with IT Quality and business stakeholders to identify and implement technology improvements.
• Drive adoption of innovative technologies including automation artificial intelligence advanced analytics and digital workflows.

Knowledge:

• Strong understanding of laboratory informatics computerized systems and digital technologies.
• Experience with laboratory applications including LIMS ELN instrumentation software and data visualization tools.
• Knowledge of AI automation digitalization and emerging technologies applicable to pharmaceutical Quality Control laboratories.
• Experience developing modifying or utilizing scripts queries or code to automate laboratory processes transform data generate metrics or integrate laboratory systems is preferred.
• Working knowledge of GMPs GLPs Data Integrity (ALCOA) 21 CFR Part 11 Annex 11 and applicable regulatory requirements.
• Understanding of computerized system lifecycle concepts including validation qualification change management and periodic review.
• Knowledge of analytical instrumentation and laboratory workflows.
• Strong project management prioritization and problem-solving skills.
• Excellent technical writing communication and interpersonal skills.
• Proficiency in Microsoft Office applications data analytics and reporting tools.
• Experience with system integration and data connectivity between laboratory instruments and enterprise systems is preferred.

Specific Education & Experience Requirements:

• 5 years of relevant experience and a BS or BA OR
• 3 years of relevant experience and a MS
  

Preferred:

• Prior experience in pharmaceutical industry is preferred
• QC laboratory operations experience across: administration enhancement integration and continuous improvement of QC computerized systems and digital solutions strongly preferred

Gileads People Leader Accountabilities:

• Create Inclusion -knowingthe business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to growdevelopand realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals purpose and organizationalobjectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
  

The salary range for this position is: $107185.00 - $138710.00. 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:

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections please view the Know Your Rights poster.

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Required Experience:

IC