Sr. Quality Associate I, QC

The primary area of responsibility will be the to support the Fibrinogen Transfer Project.

Experience with biochemistry and biology assays is strongly preferred.  As a member of the Quality Control Biochemistry Methods Development & Validation group, the incumbent will perform or assist in the following:

1. Biochemistry test method development, validation, transfer, and replacement
2. Assay troubleshooting
3. Instrument Qualification
4. ICH test method validation status of test methods, and compliance issues related to QC Laboratories.

The incumbent will perform and implement validation studies for assay methods and prepare protocols and reports for such studies that are suitable for review by regulatory agencies.

The incumbent will assist in the replacement or transfer of test methods for improving assay performance and providing laboratory efficiency through assay automation of test methods currently utilized for product release/specification testing.

Documentation will include but is not limited to, writing test procedures, test method validation reports, method development reports, and investigation reports.

• The incumbent must have hands on experience to support immunology and tissue culture assays for the QC Biochemistry laboratory and must have hands on experience in test method development and validation including preparing protocols and reports for such studies that are suitable for review by regulatory agencies.
• The incumbent must have assisted in the replacement of test methods for improving assay performance and providing laboratory efficiency through assay automation of test methods currently utilized for product release/specification testing.
• The incumbent must have demonstrated experience in the preparation of detailed technical reports including but not limited to test procedures, test method validation reports, method development reports, regulatory submission documents, and investigative reports.
• The incumbent is expected to participate in the design of experiments and interpretation of data obtained in the course of an investigation under the direction of QC Biochemistry MD&V senior staff and to strive to provide creative solutions to problems that may arise during an investigation.
• Experience within a GMP environment is strongly preferred.
• The individual’s scientific area of expertise should provide an understanding of immunology and/or immunochemistry and of analytical methods including ELISA, spectroscopic techniques, and tissue culture methods.
• The incumbent must have hands on experience with instrument qualification, software validation, and spreadsheet development and validation.
• Experience with protein analysis, purification, and characterization will be considered a plus.
• The incumbent must have strong oral and written communication skills, with the ability to effectively communicate ideas to people with varying degrees of technical understanding is essential.
• A strong working knowledge of statistical data analysis is preferred.
• Strong computer skills are essential, especially with MS Word, JMP, and Excel