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


Summary :

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 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