Sr QA Technician 1st Shift

Work Schedule

Environmental Conditions

Job Description

Summary

The Quality Assurance Inspection (QAI) department comprised of the following functions:

(1) Incoming inspection of packaging components and manufacturing materials

(2) In-Process and Final Packaging Inspections

(3) Finished Product Retain visual Inspections

(4) Water Chemical Raw Material Sampling and analysis along with ensuring compliance with applicable regulations.

The Quality Assurance Inspector is responsible for ensuring the safety efficacy purity and quality of manufactured products through compliance with relevant quality standards regulations and established procedures. The Quality Assurance Inspector is part of the Quality Assurance Inspection (QAI) Department at Ridgefield NJ. This role is responsible for performing incoming and in process inspection and be knowledgeable in the following:

Job Description

• Make sound decisions regarding packaging inspections rework operations and final disposition of incoming materials according to Sanofi policies and procedures with minimum supervision.
• Strategically prioritize in-coming inspections to accommodate Manufacturings needs.
• Act as liaison with suppliers as necessary to resolve quality issues.
• Provide quality expertise and support to the Packaging and Manufacturing Operations site (Quality Oversight logbook/AQL Inspection Forms review solve issues real time with operations personnel etc.)
• Participate in process improvements to eliminate redundant inspections/ sampling.
• Well versed in Z1.4 sampling plans
• Familiar with AQL sampling normal reduced and tightened inspections and switching rules.
• Working knowledge of cGMP as it relates to inspection activities.
• Possess the ability to read and interpret component drawings and use measurement tools such as calipers and micrometers.
• Possess the ability to evaluate certificate of analysis of chemicals/raw materials/packaging components.
• Collaborate with Purchasing Department and Suppliers to resolve incoming inspection paperwork discrepancies and shipping issues.
• Possess strong organization communication writing people skills/teamwork and detail oriented.
• Experience working in a team environment facilitating a team approach and communicating effectively.
• Practice safe work habits and adhere to Sanofi safety procedures and guidelines
• Maintains compliance to Sanofi policies and procedures.
• Knowledge of medical device or drug packaging operations.
• Flexible working schedule M-F occasional late and early hours of operation including weekends.
  

Education/ Experience

• High School Diploma (or higher) required
• 2 years experience within a GMP environment required
• Experience with SAP ERP system QualiPSO iLearn and STARLIMS a plus.
• Knowledge in CGMP/regulatory compliance