QA Specialist I- Deviations and CAPA
QA Specialist I- Deviations and CAPA
United States - New Jersey - Morris Plains
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
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.
Essential Duties and Job Functions:
The QA Specialist- Deviations and CAPA executes daily activities and maintains focuses on the Quality and Risk Management systems. This position ensures compliance with established and approved quality systems.
- Serve as an SME for Deviations and CAPA processes
- Maintains current procedures and executes quality functions within the Deviation and CAPA processes.
- Reviews Deviation and CAPA information for accuracy and conformance to established guidelines, and procedures.
- Follow impacts to associated documents and prompt update by SMEs.
- Performs data entries and generate metrics as required to maintain the health of the quality system.
- Advises and responds to queries on quality systems.
- Coordinates changes to the applicable Quality System procedures by reviewing changes for applicability, interfacing with internal approval SMEs and management, facilitating functional meetings, and acting as a liaison to bring documentation to closure.
- Identifies improvements by analyzing the current business/system processes and recommending improvements within the scope of their influence.
- Reviews quality system information for accuracy and conformance to established guidelines and procedures.
- Records and follows-up on all quality system entries.
- Provide training and/or assist in the qualification of personnel on Deviation and CAPA.
- Facilitate and/or participate in major and critical deviations (Root Cause analysis and CAPA recommendations)
- Facilitate and/or participate in MRB meetings, if needed.
Knowledge, Experience and Skills:
- 2+ years of relevant experience in a GMP environment related field and a BS.
- 3+ years of relevant experience and an AA degree.
- Prior experience in pharmaceutical industry is preferred.
- Excellent written and verbal communication skills required, including responsible business communication.
- Scientific writing experience required.
- Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
- Strong customer service philosophy required.
- Must be proficient with all MS Office applications.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical 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.
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 firstname.lastname@example.org 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.
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