- Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedures, and effective management and implementation of related documents.
- Manages controlled documentation through the document lifecycle and compliance with applicable procedures and regulatory requirements.
- Collaborates with Business Owners to ensure document changes and training requirements impact assessment are effectively managed to meet timelines.
- Delivers quality customer service and domain knowledge when working with stakeholders.
- Reviews documents to ensure changes are documented and justified in accordance with procedural requirements.
- Identifies continuous improvements to drive efficiency of the document control and training processes.
- Train users on document management and training processes, as required.
- Collect and provide data on key performance indicators. 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.
- Assists with the maintenance of programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
- Assists with the review of manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Normally receives very little instruction on routine work, general instructions on new assignments.
- Provides guidance and technical knowledge to more junior staff.
- Masters degree and 2 + years of relevant experience in a GMP environment related field; or Bachelors degree and 4+ years of relevant experience in a GMP environment related field.
- Prior experience in pharmaceutical industry is preferred.
- Provides additional support and assistance on tasks and projects as directed by management.
- Participates as required in training on issues affecting own area of work.
- Demonstrates knowledge of Document Control fundamentals, Quality Systems and Compliance with current Good Manufacturing Practices (GMPs).
- Demonstrates knowledge of the processes and impact of document management, and the relationship between the document change process and products.
- Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc.
- Demonstrates working knowledge of Electronic Document Management Systems (EDMS).
- Demonstrates knowledge of document hierarchy and document types.
- Demonstrates the ability to apply basic compliance requirements in own work area with applicable regulatory requirements.
- Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
- Demonstrates problem solving skills.
- Demonstrates proficiency in Microsoft Office applications.
- Demonstrates strong verbal, written and interpersonal communication skills.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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Quality Systems Specialist II - San Mateo, United States - Gilead Sciences
Description
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.
Join Gilead and help create possible, together.Job Description
Quality Systems Specialist II - Document Management
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need.
With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing 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 Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Reporting to the Global Quality Systems and Compliance organization, the Quality Systems Specialist II- Document Management will be responsible for partnering with Business Leaders to develop user focused and compliant procedures for the Pharmaceutical Development and Manufacturing organization of Gilead.
This role is for an individual who is ready to introduce innovative ideas and technologies to evolve how users receive GXP documentation.
Responsibilities:
Minimum Qualifications:
Preferred Qualifications:
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:
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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