QA Specialist I - Change Control

Location
Morris Plains
Salary
See job description.
Posted
May 06 2021
Ref
R0019396
Position Type
Full Time
Organization Type
Pharma
Job Type
Technician


QA Specialist I - Change Control
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


QA Specialist I - Change Control

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 strong 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:

Essential Duties and Job Functions:
  • Maintains processes in the Quality Management System (Veeva QMS) for quality systems including but not limited to Document Control and Change controls.
  • Coordinate changes to the applicable Quality System procedures by reviewing changes applicability, interfacing with internal approval SMEs and management, facilitates functional meetings and acts as a liaison to bring documentation to closure in a timely manner.
  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • May participate in developing relevant Standard Operating Procedures to ensure and maintain quality.
  • Maintains current procedures and executes quality functions within the Quality Management System (QMS).
  • May maintain programs or processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMP) and regulations.
  • Maintains and distributes quality system metrics following established procedures.
  • Reviews change controls, CAPA, document change controls and other quality records for accuracy and conformance to established guidelines and procedures.
  • Participates in cross- functional meetings with internal and external parties, as required.
  • Identifies improvements and assists end users 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.
  • Reviews all on demand monthly and quarterly work orders for the site.
  • Responsible for maintaining tracking tools/ databases.
  • Responsible for sending periodic reminder notifications to leads/ coordinators.
  • Supports management review process through development and generation of quality system metrics and trending, as well as escalation of issues as required.
  • Supports the maintenance and improvement to quality systems process, as needed.
  • Completes Quality Impact Assessments for document change controls (DCC).
  • May assist in compliance audits, as required.


Knowledge, Experience and Skills:
  • Work experience in regulated industry (biologics, pharmaceutical, medical device).
  • Experience in Quality Assurance functions and Quality Compliance functions is required.
  • Work experience with EDMS in a document control role. Veeva preferred, but not required.
  • Demonstrates knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Demonstrates basic knowledge of FDA / EMEA standards and quality system.
  • Good verbal, written, and interpersonal communication skills are required.
  • Advanced application competency, including Microsoft Word, Excel, Visio, and Outlook.
  • Excellent organization skills and attention to detail.


Basic Qualifications:

2+ years of relevant experience in a GMP environment related field and a Bachelor's degree

OR

3+ years of relevant experience in a GMP environment related field and an Associate's degree

To apply, please submit resume through our website at www.gilead.com

Gilead is an equal opportunity employer.


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---Change-Control_R0019396-2





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