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Quality Analyst III

Company: DivIHN Integration Inc
Location: Hayward
Posted on: January 15, 2022

Job Description:

DivIHN (pronounced Divine) is a nationally-recognized Business Technology Solutions and Staffing services provider headquartered in Chicago. Since our formation in 2002, we have been trusted by Fortune 500 organizations to help them locate and hire best-in-class talent through our Award-winning Professional Workforce Solutions program. - Check out our careers page to see all of our job openings: - One of our BEST F500 customers has engaged us to help them hire a -Quality Analyst III to be available -to work out of their office in Hayward, -California; details can be found below. 6 months Please apply or call one of us to learn more For further inquiries regarding the following opportunity, please contact one of our Talent Specialists Pratichi - (630) 847 0267 and Sony - (630) 847 1417 Quality Analyst III Location: Hayward, California Duration:6 months Description: Essential Duties and Responsibilities Facilitate Change Control, NCR, CAPA, Management Review, Corporate Holds, Field Corrective Actions, or other quality systems, as assigned Complete CAPA investigations, including identification of root cause and corrective/preventive actions. Complete Change Controls as needed. Serve as local administrator for electronic quality systems Lead site training for various quality systems Lead plant audit readiness efforts for the site. Provide metrics for management review meetings and other platforms as needed. Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s). When required, assist other Quality areas in the successful performance of these activities. Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items. Participate in multi-site Quality projects in the role of contributor, coordinator or lead. Balance cost, quality, people and delivery objectives to meet plant goals utilizing standard enterprise management system Other duties, tasks or projects as assigned. Qualifications Must be a strong team player with excellent problem solving, attention to detail, and good verbal and written communication skills. Must have the ability to manage people, encourage teamwork and drive decisions. Must be able to handle multiple projects concurrently. Knowledge of FDA regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices. Education and/or Experience BS in business/science Minimum of 3-5 years of experience in Quality with a medical device/Pharma company or other similarly regulated industry. Regular attendance is necessary to perform the essential functions of the job. Light work, frequent lifting up to 10 lbs; frequent standing/walking. Working Environment The work environment characteristics described are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. If not applicable, then edit or remove.) Minimal to moderate travel required. Normal office working conditions: computer, phone, files, fax, copier. Personal Protective Equipment: safety glasses as required About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status. Job Requirements:Quality, FDA Regulations, Application of Good Laboratory Practices, Application of Good Manufacturing Practices.

Keywords: DivIHN Integration Inc, Hayward , Quality Analyst III, Professions , Hayward, California

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