Sanofi Group QC Analyst II in Framingham, Massachusetts
*1st shift- Monday-Friday*
*Strong understanding Spectrometer assays*
*Strong pipette exp*
*Strong bench experience*
The Qualified individual will join the Quality Control Biopolymers Group located in Framingham, MA. Quality Control Biopolymers supports the 74/76 NYA. Manufacturing Facility business by performing in-process, stability and release testing for & product lines. Various techniques are utilized including but not limited to GC,UV-VIS, and FTIR. Additional functions include assisting of assay validations and the qualification of new instrumentation utilized in the Quality Control Laboratory.
Perform Assays in accordance with SOPs for QC testing of release, stability and in-process samples in a GMP laboratory
Review peer data including data transcription, data calculation and log entries.
General lab duties including cleaning, sample disposal, glassware washing, etc.
Update SOP's as needed
Train on all documents assigned to training plan and complete training as assigned
Receive, verify and log incoming samples.
Participate in audits.
Perform PM or calibration on lab equipment.
Conduct safety and weekly compliance walkthroughs.
Responsible for adherence to all policies, procedures and SOPs.
Participate in Lab Investigations.
Perform Out of Specification investigations as Analyst.
Work toward accomplishment of Site Goals.
Support lab operations.
Early troubleshooting of assay/equipment issues.
Participate in lab meetings.
Perform Monthly Log Changes
Basic Requirements :
- Bachelor’s degree or equivalent in Life Sciences with 2-5 years' lab experience.
Preferred Requirements :
Ability to operate basic laboratory equipment and perform standardized testing procedures in accordance with GMP guidelines. Experience with laboratory techniques such as pH, GC, UV-VIS and FTIR
Proficient in outlook, MS Word, Excel and lab based data management systems
Experience in Trackwise and Empower is a plus
Technical writing skills
Ability to follow verbal instruction, written procedures and possess strong communication skills
Flexible and adaptable to changing priorities.
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.