QA Compliance Specialist II

Company: Thermo Fisher Scientific Inc.
Location: Rockford
Posted on: May 3, 2021

Job Description:

Job Description

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

How will you make an impact?

Provide Quality Assurance Support to the manufacturing of cutting-edge in vitro diagnostic device components at the Rockford, Illinois site. Activities to ensure product quality and compliance will span all aspects of quality assurance from process development through product release. Your biggest impact will be made when combining task completion with educating team members on how and why to adhere to Quality System requirements.

What will you do?

• Serve as part of a cross-functional product development team.
• Drive completion of compliance requirements during process development.
• Complete Customer requests and specification verifications
• Review and approve engineering change notices and deviations for appropriateness and to determine potential effect on product quality
• Assist with the maintenance of ISO registration
• Investigate quality problems
• Review batch records to ensure compliant release of products
• Process product complaints, ensuring root cause is found and prevented from recurring
• Perform training on quality procedures
• Create and revise quality policies and procedures
• Collect and analyze quality data
• Perform internal audits and quality/safety GMEBA walks
• Perform all job duties in a safe manner following all safety policies
• Perform all job duties consistent with the Code of Ethics and the 4-I values, ISO standards, and regulatory/statutory requirements
• Perform other duties and cross training as assigned

How will you get here?

• Bachelor's degree required in a scientific discipline
• 2-5+ years' experience in a manufacturing or quality environment
• Knowledge of ISO standards and cGMP preferred
• Strong written and oral communication skills that generate team cooperation
• Must be able to communicate effectively with multiple levels of staff throughout the organization
• Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines
• Detail-oriented and accurate, while maintaining a vision of the end result
• Self-motivated with the ability to work as a team player and/or independently
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
• Normally receives no instruction on routine work and general instructions on new assignments and implementation of new programs
• Obtains solutions through independent analysis, and ensures organizational alignment prior to implementation
• Customer focused

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Keywords: Thermo Fisher Scientific Inc., Rockford , QA Compliance Specialist II, Other , Rockford, Illinois