Sr QA Technician - 1st Shift jobs in United States
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Thermo Fisher Scientific · 21 hours ago

Sr QA Technician - 1st Shift

Thermo Fisher Scientific is a leading company in the scientific industry, and they are seeking a Senior QA Technician to ensure the safety, efficacy, purity, and quality of manufactured products. This role involves performing inspections, collaborating with suppliers, and maintaining compliance with relevant quality standards and regulations.

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H1B Sponsor Likelynote

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 Z1.4 sampling plansSAP ERP systemMedical device packagingCommunication 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
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

Preferred

Experience with SAP ERP system, QualiPSO, iLearn, and STARLIMS a plus
Knowledge in CGMP/regulatory compliance

Benefits

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Company

Thermo Fisher Scientific

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The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.

H1B Sponsorship

Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)

Funding

Current Stage
Late Stage

Leadership Team

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Heather Stewart
HR Business Partner - Global Enterprise Services
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Laura Green
Associate Human Resources Business Partner
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Company data provided by crunchbase