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Quality Assurance Specialist

Company: N/A

Location: Round Lake, IL

Pay: N/A

Contact Information

Name: Scott Savage
Phone: n/a
Fax: n/a
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Job Description

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.

Kelly 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.

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