QA Specialist I
Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: November 21, 2022
QA Specialist IJob Responsibilities:
- Performs a wide variety of activities to ensure compliance with
applicable regulatory requirements.
- Maintains programs and processes to ensure high quality
products and compliance with current Good Manufacturing Practices
(GMP) and Good Laboratory Practices (GLP).
- Reviews manufacturing, environmental monitoring and quality
control data for in-process and finished products with guidance
from senior colleagues.
- Works with operating entities with guidance from senior
colleagues to ensure that inspections, statistical process control
analyses and audits are conducted on a continuing basis as
specified to enforce requirements and meet specifications.
- May support in the writing of annual product reviews and the
development of training programs regarding all aspects of producing
- May assist lead/coordinator with investigations and corrective
and preventive action (CAPA) recommendations related to
- May work with Research and Development during new product
start-ups and identifies routine checkpoints for new products and
- Normally receives general instruction on routine work, detailed
instructions on new assignments.Knowledge and Skills:
- Demonstrates basic knowledge of current Good Manufacturing
Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Demonstrates basic knowledge of FDA / EMEA standards and
- Demonstrates good verbal, written, and interpersonal
- Demonstrates working knowledge in Microsoft Office
application.Typical Education and Experience:
- 2+ years of relevant experience in a GMP environment related
filed and a BS.
- 3+ years of relevant experience and an AA degree.
- Prior experience in pharmaceutical industry is beneficial.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.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. 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.
Keywords: Gilead Sciences, Inc., San Mateo , QA Specialist I, Other , San Mateo, California
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