Quality Assurance Specialist III
Quality Assurance Specialist III
United States - California - Foster City
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
Quality Assurance Specialist III
Specific Job Responsibilities
- 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, disposition, deviations, CAPAs, change controls, and inspection management.
- Interface with CMO and site client groups and within the Gilead network to address investigations and quality issues requirements.
- Effectively communicate with external suppliers as part of the batch record review function 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.
- Support Qualified Person inquiries as part of Investigational Medicinal Product (IMP) disposition for EU clinical trials.
- 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.
- Works with Research and Development during new product start-ups and identifies routine checkpoints for new products and processes.
- Participates in the writing of annual product reviews, as applicable.
- Other responsibilities and duties as assigned.
Knowledge & 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.
Required Education & Experience
- A Bachelor's Degree and a minimum of seven (7) years of experience in a GMP environment related field OR Master's Degree and a minimum of five (5) years of experience in a GMP environment related field.
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 firstname.lastname@example.org 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:
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