Quality Systems Specialist III

Locations: United States - California - Foster City

Time Type: Full Time

Posted On: Vor 9 Tagen

Job Requisition ID: R0044223

Job Description

Job Responsibilities

• Independently conduct, complete, and thoroughly document critical, major, and minor deviation investigations, including investigations related to biologics manufacturing processes, facilities, or systems and other GxP operations. Will need to demonstrate ability to manage multiple deviations and meet original due dates.
• Facilitate cross-functional meetings with internal and external parties to ensure alignment with Root Cause, Impact Assessments, and CAPA development.
• Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.
• Identifying issues during the investigation that would require escalation to management, and alerting management in a timely manner.
• Supports management and tracking of quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental metric targets and maintenance of associated tracking tools/databases.
• Responsible for sending periodic reminder notifications to leads/coordinators.
• Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required.
• Supports the maintenance and improvement to quality systems processes, as needed.
• Works directly with operating entities and internal clients to ensure follow-up of quality issues.
• Participate in the development of training programs regarding all aspects of producing quality products, as required.
• Participate in compliance audits as required.
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
• Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
• Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.

Knowledge & Skills

• Demonstrates proficiency in Good Manufacturing Practices (GMPs).
• Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.
• Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution, and maintenance.
• Demonstrate strong scientific/technical understanding of biologics/large molecule operation and related regulations/guidelines.
• Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations.
• Demonstrate knowledge and application of risk management principles, including identification, controls, mitigations, and actions.
• Demonstrates audit and investigation skills, and report writing skills.
• Demonstrate ability to problem solve and lead process improvements.
• Demonstrate ability to lead cross-functional meetings and make decisions as QA representative.
• Demonstrates strong verbal, technical writing, and interpersonal skills.
• Demonstrates proficiency in Microsoft Office applications.

Education and Experience

• At least 6 years of relevant experience in a GMP environment related field and a BS or BA.
• At least 4 years of relevant experience and a MS.
• Prior experience in biologics pharmaceutical industry is preferred.

The salary range for this position is: $117,895.00 - $152,570.00. 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: Gilead Benefits

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic 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 laws.