Kelly Services Quality Assurance Specialist in Round Lake, Illinois
Kelly Services is looking for a Computer System Validation Quality Specialist in Round Lake, IL
10 month contract
Quality review / approval of computer validation documents to ensure compliance with company procedures and applicable regulatory requirements.
• Quality review and approval of computer validation documents for analytical instrument computerized systems to ensure the documents are accurate and compliant to; data integrity, computer system integrity, Baxter procedures and applicable regulations. This activity is focused on laboratory equipment utilized in the engineering, chemistry and information technology areas.
• Work cooperatively with the system owner and the validation lead to obtain agreement of documents in case of missing requirements.
• Review user manuals, standard operating procedures, validation documents, test plans, test scripts as needed.
• Present information as needed to management in various areas of Baxter.
• Approve system change control requests as needed.
• Must have strong communication oral/written skills, ability to negotiate; and willing to participate in team activities.
• Ability to work well with culturally diverse, multi-disciplined work groups, manage multiple priorities, and be self-directed in a fast-paced environment.
• Ability to work with minimal supervision.
• Excellent knowledge of Microsoft Word, Excel, Outlook, PowerPoint & SharePoint.
• Good understanding of web based and database applications.
• Strong organizational skills and attention to detail.
• Team-oriented attitude.
• Experience in writing and executing test plans/scripts.
• Experience in validating, verifying and testing software.
• Experience in a GMP and regulated environment
Education and Experience
• Bachelor’s degree (B.A./B.S.) or equivalent in science or related discipline.
• 2-4 years related experience in a pharmaceutical, biotechnology and/or biomedical industry.
• Working knowledge of computer validation requirements in government regulations including FDA 21 CFR parts 11, 58, 211, and 820, OECDs and related multinational industry standards and requirements.
• 1-2 years’ experience in computer system validation, computer system validation auditing and/or quality assurance.
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm