Sanofi Group Quality Control Analyst II in Northborough, Massachusetts
As a member of the Quality Control Raw Materials (QCRM) department, a Quality Control Analyst II’s will be expected to successfully execute the responsibilities relating to the sampling, testing, and inspection of all raw material lots. These activities include Chemical raw materials, component inspection, and final packaging.
Demonstrate proficiency in a task by completing On the Job Training.
Maintain on-time completion of all training requirements.
Perform all activities adhering to strict cGMP guidelines.
Participate in department initiatives to support continuous improvement
Perform environmental monitoring and clean room activities
Sample raw materials in accordance with SOP’s
Perform testing and inspection in accordance with SOP’s
Review peer data including data transcription, data calculation and log entries.
Lab general duties including cleaning, glassware, washing etc.
Initiate DCRs when assigned.
Participate in audits.
Perform PM calibration on lab equipment.
Conduct Safety and weekly compliance walkthroughs.
Participate in Lab Investigations and Deviations.
Adhere to site Quality and Safety Policies.
Work towards accomplishment of Site Goals.
Participate in daily metric discussions at the Gemba to include KPI's, trending, and pareto analysis of daily business drivers.
Recommends and develops ideas for improvement in operating methods and procedures to resolve problems prior to or when they arise.
Cooperates transversally to resolve customer service (internal/external) issues.
Ensures compliance with site Powered Industrial Truck Program (PIT).
Execute activities, as assigned, for the optimization, validation, transfer, and life cycle management of test methods used for release testing of raw materials
Review compendial updates and initiate workflows for corresponding revision of test methods
Coordinate logistics and communication with contract testing laboratories for supplier certification testing
Review data generated by contract laboratories (internal and external labs)
Support ongoing readiness for regulatory inspections and compliance audits
GED/ Associate’s Degree with a minimum 5 year’s experience in a cGMP Quality Control department within a FDA regulated industry (drugs, biologics) OR
Bachelor's Degree or equivalent in Science with 2-4 years’ experience in a cGMP Quality Control department within a FDA regulated industry (drugs, biologics).
Strong critical thinking, analytical and problem-solving skills.
Excellent interpersonal skills
Solid working knowledge of MS Office (Word/Excel/PowerPoint)
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.