Quality Specialist II / Temporary Position (3595)

Job Location
Germantown, MD 20874
Job Description

The Specialist II in Quality Assurance Labeling Systems, Change Control, is responsible for monitoring systems in support of FDA regulations and ISO standards, reviewing data, participating in investigations, and conducting routine process analyses. The impact of errors in the QS II position can be viewed as medium to high, depending on the discrete task being worked on. Potential errors could result in unacceptable materials being allowed in the manufacturing process and citations for regulatory noncompliance.
• Core support for Labeling Change Control and as the chief administrator of the inventoried Labeling Inspection process; these activities are in support of FDA regulations and ISO standards.
• Resource for Labeling Change Control participants on issues related to change control and manufacturing on issues pertaining to product quality.
• Significant amount of time will be spent directly interacting with Labeling change order reviewers and manufacturing staff.
• Works on projects of diverse scope, which includes the analysis of data and processes.
• Responsible for ensuring on-going compliance to applicable quality and EHS regulations and standards (e.g., ISO, US FDA, MDD, IVDD, EU-PSHA, OSHA, etc.).


3-plus years’ experience in a GMP environment and working knowledge of LP3/4 software

Personal Requirements

Must be able to communicate effectively with coworkers, both domestic and internationally.

How to Apply

If interested, please apply online www.qiagen.com/careers

As the innovative market and technology leader, QIAGEN creates sample and assay technologies that enable access to content from any biological sample.

Our mission is to enable our customers to achieve outstanding success and breakthroughs in life sciences, applied testing, pharma, and molecular diagnostics. We thereby make improvements in life possible.

Our commitment to the markets, customers, and patients we serve drives our innovation and leadership in all areas where our sample and assay technologies are required.

The exceptional talent, skill, and passion of our employees are key to QIAGEN’s excellence, success and value.

About Our Organization

QIAGEN, Inc. is a Biotechnology leader in the manufacturing of innovative, customer-driven products. Our rapid growth means that we are continuously seeking highly motivated and talented individuals to expand our operations. If you are interested in belonging to a dynamic and enthusiastic high-performing Team, developing your potential and using your skills to contribute to its success, QIAGEN, Inc. is where you should be! We recruit employees for the long term and reward them for their commitment.


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