QA Specialist III - Quality Investigations, QA Compliance

QA Specialist III - Quality Investigations, QA Compliance
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. 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


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.

QA Specialist III - Quality Investigations, QA Compliance

Role and Responsibilities:

Reporting to the Manager, Quality Compliance, the QA Compliance Specialist III will play a critical role in ensuring a continuous and sustainable state of GMP compliance, through initiation, investigation, and review of deviations. In addition, this role will initiate CAPAs as needed based on deviation findings, as well as assist and review in CAPA implementation, and perform CAPA effectiveness checks. This position will work cross-functionally with Manufacturing, Validation, Quality Control, Quality Assurance, and Facilities to support clinical/commercial biotechnology products.

Essential Duties and Job Functions:

• Triage events that occur in GMP areas to determine criticality, as well as the need for an investigation.
• Perform root cause analysis and product impact investigations for major and critical deviations.
• Collaborate with GxP Subject Matter Experts to write, review, or edit deviations and CAPAs in a clear, concise format.
• Meet key timing commitments, with well-investigated and well-documented reports.
• Coordinate and follow-up with personnel/department managers where the event occurred to gather additional information, facts, documents and applicable data.
• Utilize root cause analysis techniques during the deviation investigation process and perform prompt and thorough investigation in compliance with associated regulatory requirements.
• Determine scope, root cause, and product impact of the event.
• Assist in determining appropriate CAPA plans to address identified deficiencies, prevent reoccurrences of similar events, or prevent occurrence of potential nonconformances identified during investigations.
• Assist the Data Integrity Governance Committee with DI Investigations.
• Assist Quality Assurance in the review of investigation reports.
• Ensure Good Documentation Practices (GDP) are followed.
• Create, review and/or approve appropriate policies, directives and procedures in alignment with relevant governmental regulations/guidelines and Gilead quality standards
• Understand and apply global regulations to processes to ensure compliance.
• Provide active participation during regulatory agency inspections, as needed.
• Assist Quality Compliance management maintain a state of inspection readiness and compliance.
• Perform other related tasks and assignments as needed and specified by management related to document generation and control.

Knowledge, Experience and Skills:

• Training in investigations technique and root cause analysis tools (5 WHYs, Fishbone analysis, Is/Is-not, etc.) is preferred.
• Technical knowledge of Quality, Manufacturing, Facilities, Equipment, and/or Laboratory procedures/processes in the Biologics space is preferred.
• Take a proactive approach to continuous improvement based on data, trends and outcomes of management reviews.
• Excellent written and verbal communication skills required, including responsible business communication.
• Comfortable with ambiguity and can adapt style and tactics based on situation.
• Focus on achieving objectives within specified timeframe and to meet quality expectations.
• Knowledge of relevant GMP regulations and guidance to include but not limited to 21 CFR, ICH, EU GDP/GMP, PIC/S.
• Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
• Must be proficient with all MS Office applications.
• Ability to work independently and to make decisions based on experience.

Basic Qualifications:

• 6+ years of relevant experience in the pharmaceutical industry and a BS or BA degree.
• Prior experience in pharmaceutical industry is beneficial.

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

About 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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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