Sr QA Technician - 1st Shift

Thermo Fisher Scientific•Teterboro, NJ

6d•Onsite

About The Position

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 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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Requirements

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.
Possess strong organization, communication, writing, people skills/teamwork and detail oriented.
Experience working in a team environment, facilitating a team approach, and communicating effectively.
High School Diploma (or higher) required
2+ years' experience within a GMP environment required
Knowledge in CGMP/regulatory compliance

Nice To Haves

Knowledge of medical device or drug packaging operations.
Experience with SAP ERP system, QualiPSO, iLearn, and STARLIMS a plus.

Responsibilities

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.
Collaborate with Purchasing Department and Suppliers to resolve incoming inspection paperwork discrepancies and shipping issues.
Practice safe work habits and adhere to Sanofi safety procedures and guidelines
Maintains compliance to Sanofi policies and procedures.

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