Quality Assurance Associate

Job Description:This position will be responsible for supporting the implementation and maintenance of the Document Control, Training and Quality systems to ensure GXP compliance.Responsibilities will include, but are not limited to: • Ensure the correct and timely implementation of Document Change Notifications (DCNs). Analyze DCN packages for completeness and communicates with appropriate departments to ensure changes are well documented and easily understood. Establish priorities and deadlines for processing documents and DCNs.• Support the review, approval, distribution and maintenance of the Document Control process for GXP documentation.• Perform general word processing tasks. Check format and conformance to document templates.• Support the implementation, and maintenance of databases and other tools necessary to track Document Control activities. Ensure the correct and timely input of database entries.• Write and revise standard operating procedures (SOPs) to improve quality systems.• Maintain hardcopy and electronic documents/records and training files such that required documentation is retrievable and files are accurate and well organized.• Support and maintenance of the biennial review process.• System Administration of the Learning Management Systems in support of GXP training.• Provide administrative support for Quality Systems including follow-up on deviations, change controls and CAPAs.• Provide administrative support for the Quality Auditing system.• Creation and maintenance of periodic metrics related to quality systems

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Job Experience:Requires a BA/BS degree with a minimum of three years of quality assurance or document control experience in the biotech or pharmaceutical industry or a combination of related experiences. Qualified candidates must have effective written and oral communication skills; excellent organizational and planning skills; effective time management skills; demonstrate the ability to perform detail-oriented work with a high degree of accuracy; demonstrate good coping skills and analytical problem solving skills; and must be proficient with computers and word processing software (i.e. Microsoft Office products and Adobe Acrobat). Good working knowledge of Document Control fundamentals, Quality Systems and GMP standards. CV Therapeutics, Inc., headquartered in Palo Alto, CA, is a Biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases, the leading cause of death in the United States.CVT offers competitive salaries and an excellent benefits package, including stock options and an employee stock purchase plan. To apply for this position, please go to https://www.cvt.apply2jobs.com Equal Opportunity Employer.Minimum Education Required: BachelorYears of Experience Required: 3-5 Years