What are the responsibilities and job description for the Quality control position at Sanofi?
This position supports the execution of routine testing in the Quality Control Microbiology laboratory while strictly adhering to site work instructions, Federal Regulations, cGMP, and Sanofi Pasteur policies and procedures.
This position requires the individual to perform route testing as scheduled to support production, method validation as well as the stability program, and completing the required documentation.
JOB RESPONSIBILITIES
Knowledge of general Microbiological techniques including aseptic processing and culturing of both bacterial and viral isolates.
Demonstrated knowledge and proficiency of functions within the following systems are required : SAP, Trackwise, LIMS, MASTER, and eDoc.
Activities include assisting with maintaining safety and compliance of the laboratory work area; Performing cleaning of laboratories, equipment, and ancillary areas as required;
Attending / Contributing to scheduled team meetings, department, and safety meetings.
This position requires proficiency and understanding of the theory related to processes, assays, and equipment as well as the ability to identify issues / trends.
Participates in training activities including their individual professional development, creation / revision of training modules as well as provide training to others on processes, procedures, assays, and equipment with which they are proficient.
Demonstrate proficiency in use and knowledge of change controls, CAPAs, and the QA deviation system.
Perform initial deviation investigations through analyst interviews.
Develop a working knowledge of appropriate compendia and / or regulatory guidance.
This position will be filled as off-shift which includes second shift or weekends.
Participation in various and assigned phases of Quality Control testing.
Duties may include (but are not limited to) : Visual Evaluation of vials, syringes, plates, bottles, and canisters.
Setup and breakdown of equipment.
Documentation, waste disposal, cleaning of laboratories, and all other activities as assigned.
REQUIREMENTS
Bachelor's Degree or Master's Degree in Microbiology or Biological Sciences with 3-5 years of experience.
Prior Quality Control experiences are desirable.
Exceptional attention to detail and strong writing skills are crucial.
The individual must be familiar with cGMP guidelines.
The candidate must be able to work in a team environment.
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.
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Last updated : 2024-04-25
