QA Specialist II

Morris Plains, NJ, United States
Mar 19, 2021
Required Education
Position Type
Full time
QA Specialist II

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.

Job Summary:

Provide Quality assistance and oversight during manufacturing on the shop floor (upstream and downstream), as required. Performance of daily walkthroughs of manufacturing, storage, and warehouse areas. Reviews and approvals ancillary documentation associated with production including logbooks, forms, etc. Assists in the identification, initiation and investigations of deviation records that may result during day-to-day operations. Responsible for quarantine material storage as well as raw material inspection and release of raw materials. Assures that the quality of manufactured products complies with all applicable regulations and guidelines. Assists with the review of production batch records and associated documentation required to release a production lot, as required.

Multiple Shifts open:

1. Mon-Friday 10 -6:30 PM (Second Shift)

2. Mon-Thurs 11 to 7:30 PM (Second Shift)

3. Tues- Friday 7 to 5:30 PM (First Shift)

** all three may require occasional weekend work

Responsibilities Include:
  • Provides Quality assistance and oversight to operations on the shop floor. Supports manufacturing operations in real time to identify and address product quality and compliance issues as they arise.
  • Initiates deviation reports and participates in activities for issue resolution and initiation of CAPAs, as applicable.
  • Performs daily walkthroughs of manufacturing, storage, and warehouse areas.
  • Performs and supports changeovers in production area.
  • Reviews documentation associated with production operations.
  • Implements and ensures adherence of appropriate regulations and Gilead NJ quality standards.
  • Supports operations to encourage a Quality Culture and ensure a safe working environment.
  • Maintains appropriate records.
  • Performs Raw Material inspection and disposition.
  • Performs routine manufacturing batch production record review in support of product batch release in accordance with specifications and SOPs, as required.
  • Communicates release status to appropriate personnel.
  • Writes and reviews Standard Operating Procedures (SOPs) as needed.
  • Provides training to QA specialists and manufacturing personnel as needed.
  • Participates in process improvement initiatives.
  • Participates in audits and other projects as appropriate.
  • Assists in preparing Annual Product Quality Review as required.
  • Completes job-related training on-time as required.

Knowledge, Experience and Skills:
  • 4+ years of relevant experience in a GMP environment related field and a BS.
  • 2 + years of relevant experience and a MS.
  • Prior experience in pharmaceutical industry is preferred.
  • Biologics manufacturing experience or knowledge a plus

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:

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 for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.



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:
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