QC Operations Specialist I

Location
Foster City
Salary
See job description.
Posted
September 14 2021
Ref
R0022169
Position Type
Full Time
Organization Type
Pharma
Job Type
Other


QC Operations Specialist I
United States - California - La Verne

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. Gileads 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 companys five core values. Thats 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

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QC Operations Specialist I

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 matter, 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.

Job Description

Responsibilities (include but are not limited to):
  • Perform inventory of lab supplies and materials.
  • Maintain Sample Management areas and perform 6S supporting Quality Control Department
  • Perform laboratory walkthrough as part of inspection readiness
  • Resolve data discrepancies and missing information issues
  • Work with internal and external resources to maintain lab in an optimal state.
  • Support lab investigations regarding out of specifications (OOS) results. Address and manage deviations related to sample control.
  • Develop, revise and review SOPs, work instructions and reports.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Manage CTL testing including preparation of samples for shipment, tracking testing data packages and coordination of data entry and data review.
  • Manage Authentic Substances/ Reference Standard Inventory and Lifecycle
    • Manage inventory amounts including purchasing, physical checks and discard.
    • Monitor USP/EP expiry dates and update as necessary
    • Support qualification/requalification activities
  • Assist Sample Management with the following:
    • Perform receipt of QC samples, including processing and distribution to QC labs and off-site shipment to internal and external labs.
    • Manage QC retains and disposal of samples.
    • Maintain and operate equipment and instruments supporting sample management.
    • Participate in ad-hoc projects or other duties as needed.
    • Some overtime and weekend work as needed is required
    • Shift is a 4/10 work schedule.


Qualifications
  • Bachelor\'s degree in Biology or related discipline
  • A minimum of 3 years' experience working in sample management or a regulated business environment.
  • Proficient with sample chain of custody, general lab procedures such as operating analytical balances, working within a Biological Safety Cabinet and experience in inventory management systems such as LES and LIMS
  • Ability to work in a laboratory setting and lift up to 25 lbs.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) related to sample management/retention requirements
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, and cGMP regulations
  • Proficient in MS Word, Excel, Power Point and other applications
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities


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.



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.

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.\u200b

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.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---La-Verne/QC-Operations-Specialist-I_R0022169-1





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