This position supports execution of 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 author validation protocols/summary reports, test procedures and perform testing as scheduled to support method validation while completing required documentation.
Knowledge of general Microbiological techniques including aseptic processing, culturing of both bacterial and viral isolates, PCR, microbial bioburden as well as validation work is desired. Demonstrated knowledge and proficiency of functions within the following systems is preferred: SAP, Trackwise, LIMS, MASTER and eDoc. Activities include assist with maintaining safety and compliance of the laboratory work area; Perform cleaning of laboratories, equipment, and ancillary areas as required; Attend/Contribute 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. Demonstrated ability to work on departmental projects, author protocols/reports, as well as identify issues/ trends related to processes, procedures, assays, and equipment.
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 interview. Develop a working knowledge of appropriate compendia and/or regulatory guidance.
Prior Quality Control experience desirable. Knowledge of microbiological techniques and experience with tissue culture, sterility, bioburden, PCR and validation are preferred. Exceptional attention to detail and strong writing skills are crucial. Individual must be familiar with cGMP guidelines. Candidate must be able to work in a team environment and demonstrate the ability to find new and innovative ways of working.
Master Degree in Microbiology or Biological Sciences and 3 years’ relevant experience in a cGMP/Quality environment.
Knowledge of microbiological techniques and proven experience with sterility, bioburden, microbial cultures, document generation and validation principles are required.
Prior Quality Control experience preferred. Exceptional attention to detail and strong writing skills are crucial. Individual must be familiar with cGMP guidelines.
Candidate must be able to work in a team environment.
Participation in various and assigned phases of Quality Control testing.
Duties may include (but 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.
Candidate must pass an eye exam and receive vaccinations to be eligible for this position.
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.