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Principal QC Analyst

This position is responsible for performing 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. Responsibilities include: o Performing UV-Vis spectrophotometry  assays for in-process and final product samples o Performing HPLC/GC/SDS Page methods for final bulk material/finished goods o Performing maintenance on complex laboratory equipment including HPLC and GC systems o Investigating and troubleshooting  of Quality Control methods o Review of QC Data for compliance to procedures and specifications o Prepares statistical analysis of results o Prepares investigations related to OOS/OOT results o Participation in training of less experienced staff on new procedures o Transfers methods from support groups to the QC laboratory o Formulates solutions to laboratory issues through testing of hypothesis' o Develops and authors complex and explicit documentation for new and current procedures and technical reports. o Independently defines and implements laboratory studies related to Quality Control procedures o Implements new technologies/instrumentation in the QC laboratory o Routinely assumes leadership role in the QC laboratory Provides technical leadership and guidance for the successful completion of major laboratory projects: o Implements new quality control procedures o Transfers and develops new methods o Identifies deviations from QC methods and develops appropriate CAPA' s o Recommends method improvements o Contributes substantially to the interpretation of results and subsequent impact to product/methods o Implements and monitors personnel training o Represents QC as the prime technical contact for laboratory projects o Effectively works with others to achieve shared goals o Identifies useful resources  when applicable to meet laboratory objectives o Interacts with senior external personnel on technical matters requiring coordination between sites Works independently with minimal to no supervision and direction o Work in compliance with CGMP's o Practices safe work habits and adheres to Genzyme's safety procedures and guidelines. Basic Requirements: Bachelor's Degree in Life Sciences disciplines and 6 years' experience in CGMP lab environment OR Masters' Degree in Life Sciences discipline and 4 years' experience in CGMP lab environment. Preferred: 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 compendial regulations Scientific technical writing ability including authoring and revising SOP's or technical reports Experience troubleshooting or assay and equipment issues Expertise in analyzing particles or nanometer to micrometer sizes using SEM-DES Qualitative analysis of particles using FTIR Experience in using optical microscopes job id R2479656
Salary Range: NA
Minimum Qualification
5 - 7 years

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