Sr. Research Associate I, Quality Control

Location
Oceanside, CA, United States
Posted
Jun 08, 2021
Ref
2285580
Required Education
Bachelors Degree
Position Type
Full time
Sr. Research Associate I, Quality Control
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

Specific Responsibilities:
  • Compliance review of GMP release and stability sample results and/or method transfer results for assays such as: Appearance, pH, Osmolality, HPLC methods (Ion Exchange, Size Exclusion, and Peptide Mapping), ELISA plate-based methods (Residual Host Cell Protein, Residual Protein A, and Residual Host Cell DNA), Potency
  • Enter results and/or authorize results in LIMS for release and stability samples
  • Writes/revises and executes protocols, reports, and SOPs as needed.
  • Applies knowledge of cGMPs and Good Laboratory Practices (GLPs) daily.
  • Participates in group meetings. May present data or prepare information for others to present.
  • Leads/coordinates Quality Control and cross-functional projects with limited direction.
  • Independently plans and executes assigned experiments that support routine development activities and project goals, as needed.
  • Assist in coordinating sample management activities such as shipment and receiving.
  • Investigate deviations and Out of Specification results from Gilead and/or Contract Laboratories
  • Identify Corrective and Preventive Actions
  • May be responsible for executing laboratory work such as, but not limited to; pH, Osmometer, appearance, A280.
  • Responsible for contributing to the completion of milestones associated with specific projects related to the Quality Control department
  • Individual must be able to plan and execute assigned experiments that support Quality Control and project goals
  • May be responsible for executing equipment qualification according to an approved protocol


Required experience, and skills:
  • 4+ years of experience with AA degree
  • 2+ years of experience with BS degree in a relevant scientific discipline.
  • 0-2+ years of experience with MS degree in a relevant scientific discipline.
  • Working knowledge and proficiency with Microsoft Office software.
  • Knowledge of current Good Manufacturing Practices (cGMPs), GxP, pharmacopoeia, and regulatory requirements for testing pertaining to the pharmaceutical industry.
  • Possesses strong project and time management skills.
  • Experience generating and writing investigations related to Quality Control testing and laboratory operations.
  • Experience writing, reviewing, or executing standard operating procedures, protocols, and reports.
  • Excellent communication and strong interpersonal skills are required
  • Intermediate skills with Microsoft Office software
  • Basic to intermediate computer skills
  • Basic knowledge of safe handling of laboratory chemicals and reagents
  • Experience using laboratory and quality systems (e.g., Labware LIMS, Empower, Trackwise)
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 '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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