Quality Specialist

Thermo Fisher Scientific Inc. Allentown, PA
Job ID :


Location :

US - Pennsylvania - Allentown

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.

Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With an unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. http://www.fisherclinicalservices.com/

What will you do?

* Apply Good manufacturing Principles in all areas of responsibility.

* Demonstrate and promotes the company vision.

* Review Production Orders to ensure all information contained within is accurate per applicable reference documents and also complies with all customer requirements.

* Review finished batch records from the packaging operations for accuracy and compliance.

* Coordinate necessary clarifications or corrections with responsible Packaging/QA personnel completing records.

* Determine when Deviation Reports are required and discern if appropriate resolution is obtained.

How will you get here?

Minimum Qualifications:

* Bachelor's Degree

* A minimum of 5 years in the pharmaceutical/related regulated industry

* Experience in Quality Systems such as Documentation control and/or Quality control. Must be detail oriented to detect errors or deficiencies on batch records with the ability to use sound judgment in discerning if documentation accurately and completely reflects packaging operations. Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance.

Preferred Qualifications:

* Good written and verbal communication skills.

* Thorough understanding of regulatory documentation requirements.

* Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.

* Ability to work independently

* Experience in Microsoft Word, Excel, and PowerPoint.

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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