QA Specialist II
United States - California - Foster CityUnited States - California - OceansideUnited States - New Jersey - Morris Plains
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
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
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.QA SPECIALIST II, QUALITY ASSURANCERole and Responsibilities:
Gilead Sciences is looking for a QA Specialist II to join our QA Team. Reporting to the Manager, Quality Assurance, the QA Specialist II will play a critical role in supporting our biologics development products. This position will ensure the fulfillment of the QFSL (Quality Functional Site Lead) role and supports the Packaging and labelling oversight of biologics development products managed by the External QA team. The position will work collaboratively with key stakeholders within and outside of Quality, including QA, Analytical Operations, Supply Chain, Regulatory Affairs, as well as direct interactions with Contract Manufacturing Organization (CMO) representatives.
This position can be based out of the Foster City, CA, Oceanside, CA, or Morris Plains, NJ locations. Essential Duties and Job Functions: 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 cGMP.
Provide Quality oversight to biologics Contract Manufacturing Organization (CMO) operations including but not limited to review/approval of CMO batch records.
Process deviations, investigations, CAPAs, change controls and inspection management records related to CMOs.
Interface with CMO and site client groups and within the Gilead network to address investigations and quality issue requirements.
Effectively communicate with external suppliers to address documentation and compliance issues.
Conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
Participate in developing Standard Operating Procedures to ensure quality objectives are met.
Write, implement, review, and/or approve changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
Track, trend, and report CMO metrics and support site QMR and Executive QMR processes.
Participate in external audits of CMO and assist with internal compliance audits as required.
Perform post-inspection risk assessments of CMO regulatory inspections, identify, and implement improvements as needed.
Develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
Receives no instructions on routine work, general instructions on new assignments.
With guidance, may work with Research and Development during new product start-ups.
Other responsibilities and duties as assigned.
Knowledge, Experience and Skills:
Proficient in GMPs and/or GLPs.
Proficient in application of QA principles, concepts, industry practices, and standards.
Demonstrates ability to effectively manage multiple projects/priorities.
Has proven analytical and conceptual skills.
Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
Demonstrates excellent verbal communication, technical writing and interpersonal skills.
Demonstrates working knowledge and good proficiency in Microsoft Office applications.
Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
Ability to travel (for audits, meetings, CMO visits) as required to support the business.
- 4+ years of relevant experience in a GMP environment related field and a BS OR 2+ years of relevant experience and a MS.
- Prior experience in pharmaceutical industry is preferred.
- Preferred experience working with CMOs.
- Packaging and labelling experience is an asset.
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
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.
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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 email@example.com for assistance.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.