QC Sample Admin Specialist

QC Sample Admin Specialist page is loaded## QC Sample Admin Specialist remote type:
On-site locations:
Fremont, CAtime type:
Full time posted on:
Posted 3 Days Agojob requisition :
R5226## The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve.

Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.
** Company:
** Bionova Scientific LLC
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* Job Description:

**** Company

Summary:

** Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.

Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.
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* Position Summary:

** This position will be responsible for all aspects of laboratory controls including the administration of QC specific IT systems. This activity includes administration of master data in the LIMS system, user administration for all lab specific IT systems, design and implementation of LIMS workflows, controlled issuance of documents such as laboratory test records. It also includes general laboratory activities such as administration of releases samples, inventory control and tracking and implementation of lean and IT supported lab processes in QC.This

position will provide a high level of independent judgment and discretion in the timely identification, investigation, and resolution of issues impacting the Quality Control department related to sample management. Taking over the lead in implementing continuous improvement efforts as it relates to Quality Control activities.
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* Essential Duties and Responsibilities:

*** Administrate LIMS system, update Master Data for release and stability testing.
* Take over lead in implementation of new workflows in the LIMS improving lab efficiency and compliance.
* Be the lead in suggesting IT solutions to support lean and efficient processes within QC and the interface to other departments.
* Have oversight over sample inventory
* Present sample management processes and IT systems in internal/corporate client audits and health authority inspections.
* Responsible aliquoting and distributing samples for the appropriate QC tests.
* Key point of contact when working with internal and external partners (MFG, QA, external labs and clients)
* QC SME for IT aspects of Data Integrity initiatives
* Lead cross-functional investigations or assessments in support of change controls, CAPA/investigations, or other compliance activities as it relates to QC IT systems or sample management activities. Define appropriate corrective actions as necessary.
* Manage complex projects.
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* Working Conditions:

*** This position is required to work in a lab setting.
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* Qualifications:

*** Bachelor's Degree from an…