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Qa Specialist Ii Jobs

Company

Gilead Sciences
Address , Foster City, 94404, Ca
Employment type FULL_TIME
Salary $96,985 - $125,510 a year
Expires 2023-07-12
Posted at 1 year ago
Job Description
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer.
Gilead seeks an individual to review manufacturing, environmental monitoring, and quality control data for in-process and finished products, including master batch records, executed batch records, deviations, and change controls. You would review packaging, ARCOs, and associated packaging documents such as PMs, LM, Etc. You would also be responsible for reviewing and final release of commercial finished Goods and Development bulk and labeled products for clinical studies. Prior experience in the pharmaceutical industry is beneficial.
The DCQA team provides quality oversight for all clinical and commercial programs at Gilead. This position will be on-site at the Foster City location.
Essential Duties and Job Functions:
  • Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
  • Responsible for the review of lot disposition of manufactured products.
  • Participates in revising Standard Operating Procedures (SOPs) to ensure quality objectives are met.
  • Reviews executed manufacturing batch records and associated documents for in-process and finished products.
  • Provides QA oversight on deviations, CAPAs, and change managements.
  • Works directly with operating entities to ensure that routine inspections of GMP areas such as the manufacturing area are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • Root cause analysis based on investigative findings and with consideration of the long-term impact of decisions.
  • Interfaces with manufacturing department to address product/process issues.
Knowledge, Experience and Skills:
  • Demonstrates knowledge of cGMPs.
  • Prior experience in the pharmaceutical industry is essential, specifically support of Manufacturing QA.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.
  • Demonstrates knowledge of QA principles, concepts, industry practices, and standards.
  • Biologics Analytical methods and techniques knowledge is a plus.
Basic Qualifications:
  • OR 2+ years of relevant experience and a MS.
  • 4+ years of relevant experience in a GMP environment-related field and a BS

The salary range for this position is: $96,985.00 - $125,510.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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
'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.