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QA Specialist III - Development and Commercial

Company: GILEAD Sciences
Location: San Mateo
Posted on: June 16, 2022

Job Description:

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 DescriptionQA Specialist III - Development and CommercialSpecific Responsibilities and skills and skills for positionPerform Quality Assurance activities to ensure compliance with applicable US and international regulatory requirements in support of GMP operations for solid oral dosage forms, respiratory product, Biologic and Combination product programs as needed. Maintain routine systems and processes to ensure high quality products and compliance with Current Good Manufacturing Practices (cGMP). Perform cGMP compliance reviews of internal systems. Interface with Regulatory Affairs, Analytical Operations, Formulations, Clinical Operations personnel and CMOs as part of the quality assurance function. Skill sets required include, but not limited to, working knowledge of Current Good Manufacturing Practices regulations, familiarity with European Union regulations on investigational medicinal products, ICH Guidelines, quality assurance principles, quality systems, and industry practices. Must have critical thinking ability to exercise judgment within defined procedures and acceptable practices to determine appropriate action based on quality assessments and available data. - Be able to work independently and efficiently on routine work and can undertake more complex assignments with general guidance.Essential FunctionsSupport the Department Monthly Core Metrics reporting task. This responsibility coordinates collection of metrics from different functional teams and completion of key messages for each slide. Working with the teams to pull data from different systems including Vault, GTRACK, and Discoverant. Presenting the Monthly Core Metrics to Senior Leadership.Perform as a principle or as a backup for the Quarterly Management Review (QMR). This role is a key contributor to the coordination, scheduling, collection, drafting, presenting, and archiving of the QMR Presentation. This role is the central coordinator between approximately 12 distinct roles within multiple functional teams.Generate and coordinate collection of Monthly Highlights that are collected for publication to the wider organization on the first of every month for the previous month's data.Program Management process improvement coordinator/project manager. This role will support functional and process improvement of multiple systems including QMR, TMF, Supply Chain Table SCT, Operational functions and provision of documentation to QPs (Qualified Personnel), and international QA colleagues. Support of the Clinical Change Management function including QP and SCT metrics, training, and process improvement. Provide Instructor Lead Course Training (ILC) or assisting in the conversion of the ILC to Web-Based Training (WBT) modules.Participate in annual curriculum review and curriculum improvement. Assist in supporting FDA, GCP, GMP, and other regulatory inspection readiness activities. Internal/external audits and inspections. May also support audits from partners.Initiate and coordinate for any applicable Procedural Document revisions (SOPs and WRKs) or originating new documents as needed.Perform other work as assigned.Knowledge, Experience and SkillsDemonstrates working knowledge of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs).Demonstrates working knowledge of quality assurance systems, methods and procedures.Demonstrates knowledge of FDA/EMEA standards and quality systems.Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.Demonstrates audit and investigation skills, and report writing skills.Demonstrates good verbal, written, and interpersonal communication and presentation skills.Demonstrates proficiency in Microsoft Office applicationsAbility to work with small and large cross-functional teamsScheduling and conducting meetings (Meeting Management skills)Continuous process improvement mindsetBasic Qualifications:6+ years of relevant experience in a GMP environment related field and a BS OR 4+ years of relevant experience and a MS.Prior experience in pharmaceutical industry is beneficial.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., Canada, Australia, and Singaporeemployees 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.---For more information about equal employment opportunity protections, please view the -'EEO is the Law' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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.SummaryLocation: United States - California - Foster CityType: Full time

Keywords: GILEAD Sciences, San Mateo , QA Specialist III - Development and Commercial, Other , San Mateo, California

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