QA Specialist II
Company: Gilead Sciences
Location: La Verne
Posted on: May 28, 2023
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Job Description:
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
(https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI-/cacheable-task/2997$2151.htmld#backheader=true)
to apply for this job.
Job Description
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.
Gilead is seeking a candidate who has previous experience in pharma
(ideally bulk processing and aseptic processing) and investigations
experience. The ideal candidate would be investigating and writing
investigation summary reports for deviations across all functions,
including Manufacturing, QC, Validation, Engineering, Supply Chain,
Maintenance, and Metrology. An impartial investigator with the
ability to conduct root cause analysis and utilize critical
thinking when identifying and analyzing information accuracy and
reliability.
This position will be reporting in office at the La Verne site.
Essential Duties and Job Functions:
Performs a 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 (GMPs) and
Good Laboratory Practices (GLPs).
Participates in reviews of Standard Operating Procedures (SOPs) to
ensure instructions are clear and are consistent with quality
objectives.
Reviews manufacturing, environmental monitoring and quality control
data for in process and finished products with guidance from senior
colleagues for investigation support.
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.
Conducts or serves as lead/coordinator of investigations and
corrective action (CAPA) recommendations related to manufactured
products.
Works with operating entities to develop solutions to more complex
problems and identifies deviations from accepted practice and
evaluates impact assessment as required.
Interfaces with contract manufacturers and suppliers to address
documentation and compliance issues.
Normally receives general instruction on routine work, detailed
instructions on new assignments.
Knowledge, Experience and Skills:
Demonstrates proficiency in Good Manufacturing Practices (GMPs)
and/or Good Laboratory Practices (GLPs).
Demonstrates proficiency in application of QA principles, concepts,
industry practices, and standards.
Demonstrates thorough knowledge of FDA / EMEA standards and quality
systems, and the interface with other functions like manufacturing,
distribution and maintenance.
Demonstrates strong knowledge of six sigma, LEAN and root cause
analysis tools used for identifying and correcting deviations
Demonstrates audit and investigation skills, and report writing
skills.
Demonstrates strong verbal, technical writing and interpersonal
skills.
Demonstrates proficiency in Microsoft Office applications.
Basic Qualifications:
4+ years of relevant experience in a GMP environment related field
and a BS OR 3+ years of relevant experience and an AA degree.
Prior experience in pharmaceutical industry is beneficial.
Preferred Experience:
QA experience preferred. Educational background in the sciences
(Engineering, Biology, Chemistry).
Must have strong writing skills to present findings in a clear and
concise manner.
Must be detail-oriented and able to demonstrate a high standard of
integrity.
Must have a desire to demonstrate excellence by setting high
standards
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.
The salary range for this position is: $88,145.00 - $114,070.00.
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
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.
For more information about equal employment opportunity
protections, please view the 'Know Your Rights'
(https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
(http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
(https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf)
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
(https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI-/cacheable-task/2997$2151.htmld#backheader=true)
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 operates in more than 35
countries worldwide, with headquarters in Foster City,
California.
Following extensive monitoring, research, consideration of business
implications and advice from internal and external experts, Gilead
has made the decision to require all Canada, Australia, Singapore,
and Hong Kong employees and contractors to be fully vaccinated
against COVID-19 as a condition of employment. T he health of our
employees, contractors, their loved ones, our partners and the
communities and people we serve is a top priority. Vaccination is
the most effective way currently available to deliver on that
priority.
The purpose of the vaccination requirement is to minimize the
spread of COVID-19 in the workplace and support the health and
safety of our communities. A person is considered fully vaccinated
two weeks after the second dose of a two-dose vaccine or two weeks
after 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 an accommodation.
Keywords: Gilead Sciences, Los Angeles , QA Specialist II, Other , La Verne, California
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