QA Specialist I

Location
Morris Plains, NJ, United States
Posted
Jun 10, 2021
Ref
2257240
Required Education
Bachelors Degree
Position Type
Full time
QA Specialist I
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 of more than 6,300 people 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 18 marketed products that are benefitting 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.
Responsibilities:
Provide QA support for validation activities at the Gilead NJ manufacturing site. Reviews draft protocols for compliance with applicable cGMP regulations and best practices for biologic products. Reviews executed validation reports, and associated data for process validation, method validation, and cleaning validation activities. Assists in the identification, generation and quality approval of investigation records that may result from validation activities. As needed, assists with other aspects of the QMS system, which may include deviations, CAPAs, product quality complaints stemming from Gilead's clinical programs, and supports QA oversight and batch release of the IMP supplying the clinical programs.

PRIMARY RESPONSIBILITIES INCLUDE:

  • Reviews executed cGMP Process, Cleaning, and Method Validation documentation package associated with the biologics manufacturing processes, and additional data to ensure adherence to Gilead policies, SOPs, and cGMP requirements.

  • Reviews Process/Method/Cleaning validation draft protocols for compliance with Gilead policies, SOPs, cGMP requirements, and best practices.

  • Provides support for QA batch release and oversight of investigational medicinal product (IMP)

  • Writes, reviews, and approves Standard Operating Procedures (SOPs), as needed.

  • Supports Manufacturing and MS&T staff as needed to identify and address product quality and compliance issues as they arise.

  • Initiates deviation reports and participate in activities for issue resolution.

  • Participates in writing investigations, as needed

  • 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.

  • Provides training to QA personnel where appropriate

    CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)

  • Excellent written and verbal communication skills required, including responsible business communication.

  • Proactive, superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.

  • Must be proficient with MS Office applications.

    PHYSICAL REQUIREMENTS AND WORKING CONDITIONS

  • Environment: Work is performed in Manufacturing, GMP Warehouse, and office settings. May be exposed to chemicals if working on manufacturing floor and chemical warehouse.

  • Physical: Primary functions require sufficient physical ability to work in an office setting and operate standard office equipment including use of a computer keyboard. Light work, which includes exerting up to 25 lbs. of force occasionally and/or up to 10 lbs. of force frequently to move objects. Physical demands are in excess of those of sedentary work. Light work usually requires walking or standing to a significant degree. Gowning will be needed when entering manufacturing and GMP areas.

  • Vision: Need to pass 20/20 near focus visual acuity test (with or without correction) and be able to read font size 3 vial labels. Otherwise, needs to see in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.

    Hearing: Hear in the normal audio range with or without correction.
    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/ biologics manufacturing is beneficial.

    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.
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