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QA Specialist II

Employer
Gilead Sciences, Inc.
Location
Morris Plains, NJ
Start date
Nov 8, 2022

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Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

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

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description


QA SPECIALIST II, QUALITY ASSURANCE

Role and Responsibilities:

Gilead Sciences is looking for a QA Specialist II to join our QA Team. Reporting to the Manager, Quality Assurance, the QA Specialist II will play a critical role in supporting our biologics development product pipeline. This position will ensure the fulfillment of Quality Batch Review and Release function, including oversight of biologics development products managed by the External QA team. The position will work collaboratively with key stakeholders within and outside of Quality, including QA, Analytical Operations, Clinical Supply Chain, Regulatory Affairs, as well as direct interactions with Contract Manufacturing Organization (CMO) representatives.

This position will be based out of the Morris Plains, NJ

Essential Duties and Job Functions:
  • Perform Quality Assurance activities to ensure compliance with internal processes and procedures and applicable US and international regulatory requirements in support of current Good Manufacturing Practices (cGMP) operations.
  • Responsible for release of manufactured products including bulk, primary and secondary packaging processes.
  • Reviews and approval clinical packaging and labeling protocols, packaging specifications and packaging instructions as well as supporting clinical carton and vial labels.
  • Reviews executed batch records and supporting documentation for in-process and finished products, including master batch records, executed batch records, and change controls.
  • Effectively communicate with external suppliers to address documentation and compliance issues.
  • Interfaces with internal stakeholders and contract manufacturers to address and resolve quality issues.
  • May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
  • Works with Research and Development during new product start-ups and establishes key checkpoints for the batch release process.
  • Support strategic relationships with internal cross-functional stakeholders and CMOs
  • Maintain routine systems, programs, and processes to ensure high quality products and compliance with cGMP
  • Participate in developing Standard Operating Procedures to ensure quality objectives are met.
  • Write, implement, review, and/or approve changes to controlled documents (e.g., SOPs, Specifications, methods, etc.) as needed.
  • Other responsibilities and duties as assigned.


Knowledge, Experience and Skills:
  • Proficient in GMPs and/or GLPs.
  • Proficient in application of QA principles, concepts, industry practices, and standards.
  • Demonstrates ability to effectively manage multiple projects/priorities.
  • Has proven analytical and conceptual skills.
  • Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
  • Demonstrates excellent verbal communication, technical writing, and interpersonal skills.
  • Demonstrates working knowledge and good proficiency in Microsoft Office applications.
  • Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
  • Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
  • Ability to travel (for audits, meetings, CMO visits) as required to support the business.


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 preferred.
  • Preferred experience working with CMOs.
  • Packaging and labelling experience is an asset.


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., Canada, Australia, Singapore, and Hong Kong 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 'Know Your Rights' 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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Company

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Find Us
Website
Location
333 Lakeside Drive
Foster City
California
94404
US
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