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Thermo Fisher Scientific · 1 day ago

Sr QA Technician - 1st Shift

Teterboro, NJ

Full-time

Onsite

Mid, Senior Level

$23.80/hr - $39.66/hr

2+ years exp

Thermo Fisher Scientific is a leading company in the field of quality assurance. They are seeking a Quality Assurance Inspector responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with relevant quality standards and regulations.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

H1B Sponsor Likely

Responsibilities

Incoming inspection of packaging components and manufacturing materials

In-Process and Final Packaging Inspections

Finished Product Retain visual Inspections

Water, Chemical, Raw Material Sampling and analysis along with ensuring compliance with applicable regulations

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 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

Qualification

CGMP knowledgeAQL samplingANSI.ASQ Z1.4SAP ERPQualiPSOSTARLIMSCommunication skillsTeamworkDetail orientedProblem solving

Required

High School Diploma (or higher) required

2+ years' experience within a GMP environment required

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