Quality System Investigation Specialist
This position is responsible for maintaining several elements within the investigations Quality Systems frame work to ensure the Site compliance with current and forthcoming Biopharmaceutical and Medical Devices industries Good Manufacturing practices regulations and company policies. Acknowledge, review and/or approve site investigations and CAPAs including their correlated Corrective Actions and Preventive Actions CAPA Maintains communication with internal external customers to ensure compliance timely completion of investigations activities. Reviews investigations related to process, products, utilities, microbiology laboratory and calibrations. Supports readiness of the facility for Regulatory Inspection.
Bachelor or Master Degree in Science (Degree or master in Chemical, Engineering, Biology or Microbiology).
Five 5 years of experience in Quality Unit responsibilities in the pharmaceutical industry.
Fully Bilingual (Spanish/English) communication skills, both written and verbal are required. Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses.
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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