QA Specialist II

Location
Morris Plains, New Jersey
Posted
Sep 16, 2021
Ref
2428487
Required Education
Bachelors Degree
Position Type
Full time
QA Specialist II
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.

Role and Responsibilities:
  • Perform Product Disposition, encompassing the review of production batch records and associated documentation required to release a production lot, as required.
  • This individual manages the batch documentation package and maintains records.
  • Assists in the identification, generation and quality approval of investigation records that may result during Batch Reviews.
  • Assure the quality of manufactured products complies with all applicable regulations and guidelines.


Essential Duties and Job Functions:
  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Participates in developing Standard Operating Procedures to ensure quality objectives are met.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
  • Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
  • Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
  • Maintains day-to-day communication with the CMOs to ensure deviations, change controls, batch records, and other GMP/GDP documentation is forward processed and closed out in a timely manner.
  • Ensure that batch records are reviewed and released in a timely manner
  • Participates in the writing of annual product reviews.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
  • Works with Research and Development during new product start-ups, and identifies routine checkpoints for new products and processes.
  • May assist with compliance audits as required.
  • Interfaces with contract manufacturers to address documentation and compliance issues.
  • Demonstrates thorough knowledge of FDA/EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
  • Review CMO deviations and close out Minor investigations in validated systems. Co-review Major and Critical CMO deviations with QFSL.
  • Demonstrates audit and investigation skills, and report writing skills.
  • Demonstrates strong verbal, technical writing and interpersonal skills.
  • Review CMO process validation executed protocol
  • Taken on other task as needed


Knowledge, Experience and Skills:

  • Excellent written and verbal communication skills required, including Responsible Business Communication.
  • 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.
  • BS/BA in Biological Sciences or equivalent relevant career experience.
  • Experience with QA data review
  • Experience working with QA batch record review highly preferred
  • Practice knowledge and understanding of cGMPs.

  • Biologics or aseptic technique experience

  • Experience in commercial manufacturing (fill finish preferred)

  • Experience with batch record review and investigations is a plus

    Basic Qualifications:
    • 4+ years of relevant experience in a GMP environment related field and a BS OR 2+ years of relevant experience and a MS
    • 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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