- 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
- 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.
- 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%)
- 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*.
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Quality Assurance Specialist II - Foster City, United States - Gilead Sciences
Description
Job Description
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:
Essential Duties and Job Functions:
Knowledge, Experience and Skills:
Basic Qualifications:
