Sr QC Specialist
Sr QC Specialist
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$ 123930 - 160380
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 lifechanging 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
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 requalification 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.
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 nonjob related characteristics or other prohibited grounds specified in applicable federal state and local laws. In 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 theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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:
Senior IC
Employment Type
Full-Time
