Quality Technician Associate

Job description

**2nd shift position including rotating weekends and holidays**

The Associate Quality Control Technician will perform a variety of cross functional tasks within QC VIMM, including Visual Inspections, Sample Receipt, and Service Area related work by strictly adhering to Sanofi Pasteur's policies and procedures, and cGMP requirements. This position will also be responsible for cleaning of work areas and associated equipment.

The selected candidate will work to ensure tasks are completed in a safe, compliant, and timely manner.

    

Testing:

·  Perform Visual Inspections for Customer Complaints, Stability, Retention, and AQL Programs. Perform various testing, Sample Receipt, and Service Area tasks by strictly adhering to SOP, SWI, Federal Regulations, cGMP, training modules, Sanofi Pasteur policies and procedures, and safety requirements.
·  Performs task as per testing schedule defined by laboratory management to meet demands of our internal and external customers, including, but not limited to Production, Method Development, Validation, Independent Demand, and Stability.
·  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.
·  Performs system related functions: SAP (Cycle counts, confirmations, inventories, etc.), LIMS (inventories, chain of custody, GMP data, etc.), Labwatch, 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 implementation of Change controls, CAPAs, and other related processes.
·  Notifies laboratory manager of any deviations or issues and initiates incident investigations as required.
·  Support deviation investigations.

All other duties as assigned.

Qualifications:

·  BA/BS in life sciences or HS Diploma with 2+ years' experience in a cGMP controlled/pharmaceutical industry.
·  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 contract sites, as well as outside vendors to ensure that GMP data is available in a timely manner.
·  Vaccinations may be required. 20/20 vision with corrective eyewear required

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.