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Quality Assurance Validation II, QAV Specialist


Location: Lexington, Massachusetts
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Job Title: Quality Assurance Validation II, QAV Specialist

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information
Thermo Fisher Scientific, Viral Vector Services (VVS) is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members; are committed to making a difference in our organization, for our client partners and the patients we serve.

How will you make an impact?
Thermo Fisher Scientific, VVS division, is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve.

What will you do?
•       Provide quality oversight of facility/utility and equipment for qualification activities.
•       Review all qualification documents for equipment and systems such as URS, DQ, SAT, FAT, design documents and protocols (IQ, OQ & PQ).
•       Carry out duties in compliance with all local, state, and federal regulations and guidelines including the FDA and EU.
•       Comply with all global and site policies and procedures.
•       Provide technical support on change controls, assessing new change controls for process equipment, utilities and automation systems that are proposed and all the requirements necessary to maintain a validated status.
•       Provide quality oversight of engineering and validation studies, as well as data analysis and compilation of data and results into summary reports.
•       Support review and approval of generation of quality assurance policies and procedures
•       Support, interpret and implement quality assurance standards
•       Participate in all aspects of QAV operations within the facility, to support deviation investigations, change controls, customer quality support and SOP review.
•       Provides Quality support to the life cycle of analytical equipment / instrumentation and analytical method validation / verification.
•       The position involves close collaboration with Engineering, Manufacturing, EHS, Quality Control, and other teams to complete all responsibilities

How will you get here?
Education
A B.S. degree in science/engineering field.

Experience
•       3-5 years’ experience in quality and compliance for site Utilities, Equipment and Automation in a sterile environment.
•       Must have strong knowledge of 21 CFR, ICH Q9, ICH Q10, ISO-14644, GAMP5, ASTM-E2500 and EU regulations
•       Must be able to understand operational documents for GMP compliance, accuracy and completeness
•       Experience with qualification for the following systems: WFI, Clean steam, process gases, HVAC Bioreactors, Autoclaves, Chromatography skids, Tangential flow filtration (TFF)etc.
•       Experience with the qualification of single use technology is desired.
•       Experience with the qualification of a drug product fill line (including isolator, filler) and Aseptic Process Simulation (APS) is desired.

Knowledge, Skills, Abilities
•       Able to plan, coordinate and perform with minimal oversight
•       Strong interpersonal and communication skills.
•       Strong understanding of applicable regulatory requirements (FDA and EMA).
•       Ability to function in a dynamic environment and balance multiple priorities simultaneously
•       Ability to make decisions with minimal to moderate supervision
•       Ability to aseptically gown and /or sterile gown as needed

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