Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Warehouse

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 Manufacturing’s 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 ANSI.ASQ Z1.4 sampling plansFamiliar 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) required2+ years' experience within a GMP environment requiredExperience with SAP ERP system, QualiPSO, iLearn, and STARLIMS a plus.Knowledge in CGMP/regulatory compliance