Senior Quality Technician - Vaccine

Senior Quality Technician - Vaccine

POSITION SUMMARY:

This position supports execution of routine testing in the Quality Control Microbiology laboratory while strictly adhering to site work instructions, Federal Regulations, cGMP, and Sanofi policies and procedures.  This position requires the individual to perform routine testing as scheduled to support production, method validation as well as the stability program and completing required documentation. 

Knowledge of general Microbiological techniques including aseptic processing and serial dilutions.  Demonstrated knowledge and proficiency of functions within the following systems is required: 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, identify issues/ trends related to processes, procedures, assays, and equipment.

Participates in training activities including their individual professional development, 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. This position may be filled as off-shift which includes second shift or weekends.

Prior Quality Control experience desirable. Knowledge of microbiological techniques and experience with time sensitive testing including sterility and bioburden are preferred. Exceptional attention to detail and strong writing skills are crucial. Ability to revise documents and forms for both triennial review and process improvements. Individual must be familiar with cGMP guidelines. Candidate must be able to work in a team environment.

This position will be filled as an off-shift position.

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 to be eligible for this position. 

Technical Competencies and soft skills:

• Knowledge of cGMP and regulatory requirements

• Excellent analytical, organizational and computer skills

• Ability to work efficiently individually or within a team environment with great attention to detail 

• Knowledge of microbiological techniques and experience with both bacterial and viral testing including, but not limited to, EM reads, bioburden, Yellow Fever potency and ID, Dengue, cell culture, egg-based testing, documentation generation and review is desired.

• Excellent communication, interpersonal, organization and teamwork skills

• Ability to assist others in troubleshooting activities and

• Proficiency with several of the following systems is required: SAP, Trackwise, LIMS, Master, eDoc

• Participate in training activities including creation/revision of training modules as well as provide training to others on processes, procedures, assays, and equipment with which they are proficient

QUALIFICATIONS:

• Bachelor Degree in Microbiology or Biological Sciences and 2-4+ years relevant experience in a cGMP/Quality environment.

• Knowledge of microbiological techniques and experience with bacterial testing is 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.

• This position may be filled as an off-shift position.

• 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. 

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE

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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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.