Sanofi
Healthcare
MaterialReleaseQualityTechnician
“Material Release Quality Technician at Sanofi. Skills: Quality inspections, documentation verification, cGMP, raw material release. Perform Quality inspections on incoming material inspections. documentation verification”
What You'll Achieve.
ensure all duties are completed on time; meet the demands of the production schedule; ensure timely disposition within agreed upon timelines to support production scheduling and or marketing expectations; surpass milestones
Industry & Context.
identifying, and working to solve problems
Forklift Certification
What They're Looking For.
Must Have
High school diploma or equivalent, minimum of 1 year of relevant experience in a cGMP-regulated pharmaceutical or biotechnology environment, organizational, written, interpersonal, and teamwork skills, Solid understanding of current Good Manufacturing Practices (cGMPs)
Nice to Have
Bachelor’s degree (BAS) in Life Sciences or a related field, at least 1 year of relevant experience in a cGMP-controlled pharmaceutical setting, Experience with systems such as SAP, LabWare, EDMS, FaCT, SMS, and Aseptic Technique is a plus, Forklift Certification preferred
What You'll Do.
Perform Quality inspections on incoming material inspections
documentation verification
statistical sample removal
status tagging of materials
Perform cleaning of work areas
and any other jobs as required
ensure all duties are completed on time
complete required Safety and Compliance training and associated training modules as assigned
and release of raw materials
Maintains laboratory in a safe and compliant state
Manages inventory of raw material sampling utensils
Performs cleaning of laboratories sampling equipment as required
Processes and inspects product samples from contract manufacturers as well as other Sanofi sites
Ensures cold chain of custody is kept on samples and samples are distributed to the applicable testing unit
Performs inspections for raw materials within the building 38 warehouse and associated off site warehouse locations
Performs inspections and sampling for intermediates
and finished product released by Product Release
Attends and contributes to scheduled team meetings
Performs document and procedure review as needed
Trains on departmental training modules as assigned
Pursues professional and or technical development training on/off site
Understand and support implementation of change controls
and deviation corrective actions
Notifies lab manager of any deviations or issues and initiates deviation investigations as required
Supports deviation investigations
recording GMP data correctly
Attention to detail in recording GMP data right first time into GXP documents
The ability to handle multiple priorities (and respect timelines) is required in order to surpass milestones
The ability to negotiate
work with and influence a variety of people in a positive manner while identifying
and working to solve problems is a requirement of the position
The incumbent must be able to work effectively with colleagues at other Sanofi
and outside vendors to ensure that GMP data is available in a timely manner
The position may require that the incumbent interacts with external customers as a representative of Quality Operations
The incumbent must process raw material batches to ensure timely disposition within agreed upon timelines to support production scheduling and or marketing expectations
The incumbent must work within the policies
and regulations as required by the Company and under the Occupational Health and Safety Act
How You'll Work.
Team & Collaboration
Attends and contributes to scheduled team meetings, department meetings, and safety meetings; work effectively with colleagues at other Sanofi, contract sites, and outside vendors; interacts with external customers as a representative of Quality Operations
Communication Scope
written skills; interpersonal skills
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