Quality Systems Specialist II
Quality Systems Specialist II
United States - California - San Dimas
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
Gilead Sciences is currently seeking a QC Quality Systems Specialist II for the La Verne Commercial Manufacturing site in Southern California. This position will support Quality Control (QC) operational activities related to management and maintenance of laboratory instrumentation and equipment and interfaces with the Gilead Quality Management Systems.
Roles and Responsibilities:
- Primary responsible for management of QC Instrumentation including Installation, Operation and Performance Qualification (IOPQ), routine maintenance and repair, and calibration/re-calibration and qualification maintenance (QM).
- Other responsibilities include scheduling and liaising with service providers, general troubleshooting, protocol and report generation, and procedure generation and revision.
- Supports technical review of data generated from instrument qualifications, repairs, maintenance.
- Supports the generation of Quality Metrics and Reports
- Conducts troubleshooting of lab equipment
- Supports validation lifecycle document development for QC analytical instrumentation
- Participates in validation and commercial/developmental manufacturing activities as required
- May performs procedural and method revisions
- May support laboratory investigation and CAPA implementation
- May support on-the-job training for new team members
Knowledge and Skills:
- Advanced knowledge of current Good Manufacturing Practices (GMPs), principals of ALCOA and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.
- Working knowledge in general Microbiology and/or Chemistry techniques such as gram staining; microbial identification, aseptic technique, plate streaking technique compendial identification tests and complex chromatographic analyses and/or working knowledge in laboratory analytical instrumentation Installation, Operational, Performance Qualification (IOPQ), validation, maintenance and troubleshooting.
- Strong knowledge of regulatory requirements surrounding Data Integrity.
- Knowledge of Quality Control and Quality Management Systems.
- Working experience with controlled document management, change management, and procedure updates preferred.
- Ability to apply critical thinking and good judgment.
- Strong organizational and problem solving skills.
- Strong verbal, written, and interpersonal skills are required.
- Working knowledge of laboratory systems such as HPLC/UPLC, UV, endotoxin kinetic chromogenic methodology (LAL) is preferred
- Working experience in laboratory computerized systems such as Empower, LIMS, other equipment software, quality management software (Trackwise, Veeva Vault, etc.) and/or computerized maintenance management systems (IBM Maximo, Cal Man, etc.)
- Proficiency in Microsoft Office applications
Education and Experience:
- 4+ years of relevant experience and a BS, or degree in related fields
- 2+ years of relevant experience and a MS degree
- 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 firstname.lastname@example.org 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:
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