QA Specialist I- 2nd Shift

Location
Morris Plains
Salary
See job description.
Posted
May 22 2021
Ref
R0019580
Position Type
Full Time
Organization Type
Pharma
Job Type
Other


QA Specialist I- 2nd Shift
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.

Working in Quality Assurance at Gilead: Quality Assurance delivers on Gilead's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

Essential Duties and Job Functions:

Quality Assurance on the floor is responsible for coordinating, managing on the floor Quality Oversight within commercial Drug Product operations to ensure sustained compliance with GMPs and regulatory readiness.

** This is a second shift position hours may be:

12 noon to 10:30pm Mon-Thurs OR

2pm- 12:30 am Tues- Fri

PRIMARY RESPONSIBILITIES:

  • Provides Quality oversight to operations on the shop floor. Supports manufacturing operations (upstream and downstream) at real time.

  • Assists and advises on pertinent quality issues as they arise during plant operations.

  • Troubleshoot and elevate noncompliance issues and events observed.

  • Demonstrates knowledge of investigation, CAPA, and corrective action processes.

  • Demonstrates ability to effectively prioritize and manage multiple project workloads

  • Ensures compliance to policies and procedures

  • Maintains and supports material inventory, status and transfers.

  • Performs and supports changeovers in production area as required.

  • Participates in audits and other projects as appropriate.

  • Supports manufacturing operations (upstream and downstream) and staff as needed to identify and address product quality and compliance issues as they arise.

  • Reviews documentation associated with production operations. Ensures adequate levels of documentation are acceptable and compliant to existing procedures.

  • Participates in process improvement initiatives targeting for Right First Time (RFT) on documentation.

  • Participates in activities associated with event resolution and CAPAs, with a focus on organizing and attending cross-functional meetings.

  • Implements and ensures adherence of appropriate regulations and Gilead quality standards.

  • Supports operations to encourage a Quality Culture and ensure a safe working environment.

  • Completes job-related training as required.

    Knowledge, Experience and Skills:

    2+ years of relevant experience in a GMP environment related field and a BS OR 3+ years of relevant experience and an AA degree.

    Prior experience in pharmaceutical industry is preferred.

    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.

    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.


    To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---New-Jersey---Morris-Plains/QA-Specialist-I--2nd-Shift_R0019580





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