QA Specialist I
Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: January 12, 2021
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Job Description:
QA Specialist I United States - California - Oceanside 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 Job Responsibilities
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. Maintain routine
systems, programs, and processes to ensure high quality products
and compliance with current Good Manufacturing Practices (cGMP).
Review manufacturing batch records, executed batch records, and
supporting documents for Biologics Drug Substance and Drug Product
lot disposition. Develop solutions to more complex problems and
identifies deviations from accepted practice and evaluates impact
assessment as required. May assist with compliance audits as
required. Maintain electronic records and paper archives (e.g, lot
history records, reports, data). Process deviations,
investigations, and corrective and preventive action (CAPA)
activities related to manufactured products. Effectively
communicate with external suppliers as part of the batch record
review function to address documentation and compliance issues.
Participates in changes to controlled documents (e.g., SOPs,
specifications, methods, etc.) as needed. Receives general
instructions on routine work, detailed instructions on new
assignments. With guidance, may work with Research and Development
during new product start-ups. Other responsibilities and duties as
assigned. Skills Relevant working knowledge of current Good
Manufacturing Practices (cGMP) regulations, quality assurance
principles, systems, and industry practices. Must have critical
thinking ability to exercise judgment within defined procedures and
acceptable practices to determine appropriate action based on
quality assessments and available data. Must recognize deviations
from accepted practices. Be able to work independently and
efficiently on routine work and can undertake more complex
assignments with general guidance. Good verbal, written, and
interpersonal communication skills are required. Demonstrates
working knowledge in Microsoft Office applications. Typical
Education & Experience Require AA/BS degree and minimum 2 years of
relevant experience. Prior experience in pharmaceutical industry is
preferred. 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 careersgilead.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.
Keywords: Gilead Sciences, Inc., Oceanside , QA Specialist I, Other , Oceanside, California
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