Sr. Quality Associate I, QC
About The Position
The primary area of responsibility will be to support the Fibrinogen Transfer Project. As a member of the Quality Control Biochemistry Methods Development & Validation group, the incumbent will perform or assist in biochemistry test method development, validation, transfer, and replacement, assay troubleshooting, and instrument qualification. 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.
Requirements
- Hands-on experience to support immunology and tissue culture assays for the QC Biochemistry laboratory.
- 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.
- 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.
- 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.
- Hands-on experience with instrument qualification, software validation, and spreadsheet development and validation.
- Strong oral and written communication skills, with the ability to effectively communicate ideas to people with varying degrees of technical understanding.
- Strong computer skills, especially with MS Word, JMP, and Excel.
Nice To Haves
- Experience with biochemistry and biology assays is strongly preferred.
- 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.
- Experience with protein analysis, purification, and characterization will be considered a plus.
- A strong working knowledge of statistical data analysis is preferred.
Responsibilities
- Support the Fibrinogen Transfer Project.
- Perform or assist in biochemistry test method development, validation, transfer, and replacement.
- Perform or assist in assay troubleshooting.
- Perform or assist in instrument qualification.
- Perform and implement validation studies for assay methods.
- Prepare protocols and reports for validation studies.
- Assist in the replacement or transfer of test methods for improving assay performance.
- Provide laboratory efficiency through assay automation of test methods currently utilized for product release/specification testing.
- Write test procedures, test method validation reports, method development reports, and investigation reports.
- 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.
- Strive to provide creative solutions to problems that may arise during an investigation.
- Perform or assist in immunology and tissue culture assays for the QC Biochemistry laboratory.
- Perform or assist in test method development and validation including preparing protocols and reports for such studies that are suitable for review by regulatory agencies.
- Assist 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.
- Prepare detailed technical reports including but not limited to test procedures, test method validation reports, method development reports, regulatory submission documents, and investigative reports.
- Perform or assist with instrument qualification, software validation, and spreadsheet development and validation.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
