Sr Quality Assurance Specialist
Sr Quality Assurance Specialist
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Quality Assurance delivers on Gilead's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.
As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Meet the worldwide QA Team: https://qualityassurance-careers.gilead.com/
Senior Quality Assurance Specialist
Gilead in Foster City is seeking a talented QA professional to support our development and commercial businesses. This role will focus on Quality projects across the organization including Gilead enterprise systems support (developing and maintaining procedures, business processes, user requirements, etc), manage and administer local systems, develop training materials and provide instructor-led training for local systems and selected enterprise systems, dispositioning materials provided by external collaborators for use in the manufacture of Gilead products, and managing CMC changes with external collaborators.
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
- Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.
- May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
- May interface with regulatory agencies as required Interfaces with contract manufacturers to address documentation and compliance issues.
- May assist or lead compliance audits as required.
- Knowledge and Skills
- Proficient in GMPs and/or GLPs.
- Proficient in application of QA principles, concepts, industry practices, and standards.
- Demonstrates ability to effectively manage multiple projects/priorities.
- Has proven analytical and conceptual skills.
- Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
- Demonstrates excellent verbal communication, technical writing and interpersonal skills.
- Demonstrates working knowledge and good proficiency in Microsoft Office applications.
- Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
- Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control
- Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
- Demonstrates strong ability to drive programs forward by influencing and supporting contributors and across organizational levels.
- 7+ years of relevant QA experience in a GMP environment related field and a BS or BA or 5+ years and a MS.
- Prior experience in pharmaceutical industry
- Experience with data analytics, data extraction and creating metrics and useful dashboards
- Experience with Quality Assurance and pharma Industry software and systems.
- Ability to manage and lead projects in a cross functional environment.
- Experience creating workflows and changes management for quality systems.
- Strong critical thinking skills
- Excellent communication skills required.
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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. 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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' 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 log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Sr-Quality-Assurance-Specialist_R0016059
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