Offers “Sanofi”

Expires soon Sanofi

Quality Technician

  • Internship
  • Swiftwater, USA

Job description



  **Hours could be one of the following shifts. Hours include flexibility, over-time, holidays and/or weekends if needed**
Monday- Friday- 8am-4:30pm
Tues-Sat 8am-4:30pm
Sun-Thursday 8am-4:30pm

 
This position supports the execution of routine testing in the Quality Control Bioassay 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 required documentation. 

·  Knowledge of general Immunological techniques including ELISA and immunodiffusion based assays. 
·  Demonstrated knowledge and proficiency of functions within the following systems are required: SAP, Trackwise/Phenix, LIMS, and eDoc/Geode+.
·  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.
·  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. 

  

Key Accountabilities:
  
Testing:  

·  Performs current tests by strictly adhering to SOP, SWI, Federal Regulations, cGMP, training modules (when applicable), Sanofi Pasteur policies and procedures and safety procedures.
·  Performs testing as per the testing schedule defined by laboratory management to meet demands of Production, Methods Development, Validation, Independent Demand, and Stability program. 
·  Completes required paperwork and documentation as required.
·  Ensures product integrity by testing products, pulling samples, placing work orders and visual inspection of samples.
·  Prepares for and operates QC equipment including pre and post run setup and maintenance.
·  Troubleshoots sample discrepancies.
·  Performs peer proofing on assays.

Laboratory:

·  Maintains laboratories in a safe and compliant state.
·  System-related functions: SAP (Cycle counts, confirmations, inventories, etc.), Trackwise (MDOs & IPDNs), LIMs (inventories), etc.
·  Performs cleaning of laboratories, equipment, and ancillary areas as required.

Training :

·  Attends/Contributes to scheduled team meetings, department meetings, and safety meetings.
·  Document review.
·  Safety and compliance training.
·  Module/Assay training as assigned.
·  Professional/Technical development training on/ off-site as assigned.

Compliance:

·  Understand and support the implementation of Change controls, CAPAs, and deviation corrective actions.
·  Notifies laboratory manager of any deviations or issues and initiates incident investigations as required.
·  Support deviations.

All other duties as assigned
 
Basic Qualifications:

·  4 years' science degree ( Biology, Immunology and related disciplines)
·  1 - 3 years of relevant experience (immunology, biology).
·  Good mathematical skills and computer literacy.
·  Excellent organizational, verbal communication, and written communication skills.
·  Ability to work efficiently with minimal error and high attention to detail.
·  Experience directly working in a cGMP facility, including QC testing is preferred.

Preferred Skills:

·  Prior Quality Control experience desirable.
·  Knowledge of immunological techniques that include ELISA, HAI (Hemagglutinin inhibition) and immunodiffusion techniques.
·  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.

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.

#GD-SP

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.

Make every future a success.
  • Job directory
  • Business directory