- Review and approve master batch records, labels, specifications and other pre-production documents for Clinical/Commercial Drug Product in compliance with FDA and international health agency requirements.
- Review executed production batch records, environmental monitoring data (as required), and associated documentation, including any deviation and investigation reports related to lot release of Clinical/Commercial Drug Product in support of product disposition.
- Lead or coordinate investigations and corrective and preventive action (CAPA) recommendations
- Interface directly with contract manufacturers and alliance partners to manage quality related issues with minimal supervision.
- Interact with key stakeholders such as Formulation and Process Development, Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that Clinical/Commercial Drug Products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations.
- Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.
- Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Write, revise, and review standard operating procedures.
- Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
- Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices GLPs).
- Works with Research and Development during new product start-ups and identifies checkpoints for new products and processes.
- Normally receives very little instruction on routine work, general instructions on new assignments.
- Assist in departmental planning activities to ensure that deliverables are provided according to project timelines
Essential Duties and Job Functions: - Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
- Maintains routine 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 directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified 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 identifies checkpoints for new products and processes.
- Normally receives very little instruction on routine work, general instructions on new assignments.
Knowledge, Experience and Skills: - Good working knowledge of Quality Systems, FDA/EMEA Standards, current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
- Excellent knowledge of six sigma, LEAN and root cause analysis tools for identifying and correcting deviations
- Ability to work on complex, non-routine assignments where analysis of the situation or data requires a review of identifiable factors
- Ability to effectively participate in cross-functional teams
- Ability to coordinate the planning, organization, and implementation of project deliverables within specified objectives
- An accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures
- Excellent attitude with strong verbal, technical writing, and interpersonal communication skills
- Self-starter, able to work independently
- Experienced business traveler a plus (approximately 10%)
Basic Qualifications: - 4+ years of relevant experience in a GMP environment related field and a BS OR 2+ years of relevant experience and a MS.
- Prior experience in pharmaceutical industry is beneficial.
- Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Demonstrates knowledge of FDA / EMEA standards and quality systems.
- Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates good verbal, written, and interpersonal communication skills.
- Demonstrates proficiency in Microsoft Office applications.
The salary range for this position is: $99, $129, 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:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know 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 log onto your Internal Career Site to apply for this job.
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Quality Assurance Specialist II - Foster City, United States - Gilead Sciences, Inc.
Description
Quality Assurance Specialist IIUnited 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. Gilead's 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 company's five core values. That's 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
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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
Role and Responsibilities:
