The Quality Control Analyst Principal position, within Quality Control Chemistry is responsible for testing intermediate and final product samples to demonstrate that all products meet all standards required for CGMP operations. Various techniques are utilized in Quality Control including, HPLC, UPLC, GC, Gel Electrophoresis and multiple types of spectrophotometry and microscopy. Additional functions include stability testing, assay transfers, the qualification of new instrumentation utilized in the Quality Control laboratory, and particle ID analysis, method transfer, and method validation.
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.
KEY RESPONSIBILITIES INCLUDE:
(Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.)
· Performing UV-Vis spectrophotometry assays for in-process and final product samples
· Performing HPLC/GC/SDS Page methods for final bulk material/finished goods
· Performing maintenance on complex laboratory equipment including HPLC and GC systems
· Investigating and troubleshooting of Quality Control methods
· Review of QC Data for compliance to procedures and specifications
· Prepares statistical analysis of results
· Prepares investigations related to 00S/OOT results
· Participation in training of less experienced staff on new procedures
· Transfers methods from support groups to the QC laboratory
· Formulates solutions to laboratory issues through testing of hypothesis'
· Develops and authors complex and explicit documentation for new and current procedures and technical reports.
· Independently defines and implements laboratory studies related to Quality Control procedures
· Implements new technologies/instrumentation in the QC laboratory
· Routinely assumes leadership role in the QC laboratory - Provides technical leadership and guidance for the successful completion of major laboratory projects:
· Implements new quality control procedures
· Transfers and develops new methods
· Identifies deviations from QC methods and develops appropriate CAPA's
· Recommends method improvements
· Contributes substantially to the interpretation of results and subsequent impact to product/methods
· 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 years' 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 compendial regulations
· Scientific technical writing ability including authoring and revising SOPs or technical reports
· Experience troubleshooting of assay and equipment issues
· Expertise in analyzing particles of nano-meter to micrometer sizes using SEMEDS
· Qualitative analysis of particles using FTI R
· Experience in using optical microscopes
SPECIAL WORKING CONDITIONS:
· Must be able to lift 40 lbs
· Must be able to gown to gain entry into lab area
· Must be able to work a flexible schedule on a periodic basis based on business need
· Position is considered essential and may be required to staff the lab during inclement weather events
Job Grade: L2-1
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.