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This position is responsible for performing some routine and complex techniques associated with daily QC release and provides an in-depth investigative and technological orientation in implementing, executing and interpreting quality procedures and test methods. Successful candidate will substantially contribute to process and method improvements within the Quality Control laboratory.
Perform UV-Vis spectrophotometry assays,LCS,HPLC/GC/SDS-PAGE methods for in-process and final product samples.
Perform maintenance on complex laboratory equipment including HPLC and GC systems.
Investigate and troubleshoot Quality Control methods.
Review QC Data for compliance to procedures and specifications.
Prepare statistical analysis of results.
Prepare investigations related to 005/00T results.
Participate in training of less experienced staff on new procedures.
Transfer methods from support groups to the QC laboratory.
Formulate solutions to laboratory issues through testing of hypotheses.
Develop and author complex and explicit documentation for new and current procedures and technical reports.
Implement new technologies/instrumentation in the QC laboratory.
Routinely assume leadership role in the QC laboratory.
Provide technical leadership and guidance for the successful completion of major laboratory projects:
Implement new quality control procedures.
Transfer and develop new methods.
Identify deviations from QC methods and develop appropriate CAPAs.
Recommend method improvements.
Contribute substantially to the interpretation of results and subsequent impact to product/methods.
Represent QC as the prime technical contact for laboratory projects.
Work effectively with others to achieve shared goals and meet timelines.
Interact with internal and external personnel on technical matters requiring coordination between sites.
Work independently with minimal to no supervision and direction.
Work in compliance with cGMPs.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly,fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Experiencewith Dionex, GC, HPLC,Gel Electrophoresis, UV Vis Spectroscopy and wet Chemistry.
Experience with Empower software.
Bachelor's Degree in Life Sciences discipline and 6 years experience in cGMP lab environment, or
Master's Degree in Life Sciences discipline and 4 year experience in cGMP lab Environment.
Proficient in MS Office and lab based data management systems.
Ability to present technical data.
Ability to work independently on scientific projects.
Familiarity with USP and global compendia! regulations.
Scientific technical writing ability including authoring and revising SOPs or technical reports.
Experience troubleshooting of assay and equipment issues.
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