Job Details

QC Sample Admin Specialist page is loaded## QC Sample Admin Specialistremote type: On-sitelocations: Fremont, CAtime type: Full timeposted on: Posted 3 Days Agojob requisition id: 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**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.**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.**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.**Working Conditions:*** This position is required to work in a lab setting.**Qualifications:*** Bachelor's Degree from an accredited institution in Chemistry, or Biology (or closely related degree).* Strong IT background.* Requires 2-5 years of pharmaceutical or medical device experience.* Experience with pharmaceutical IT systems (e.g. LIMS, eBR, Enterprise Management Systems (EMS), or Enterprise Resource Planning Systems (ERP))* Strong independent judgment and decision-making abilities and strong conflict resolution required.* Knowledge and experience with 21 CFR Part 11 and Annex 11 compliance.* Participates in Data Integrity and continuous improvement initiatives.* Participates or experience leading projects with history of achieving results.* Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little supervision.* Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.Compensation Range: The base compensation range for this role is between $85,000 and $100,000. However, the actual compensation may vary depending on your experience and qualifications.Health Benefits and Program: Bionova offers health benefits at a subsidized rate.Healthcare, Dental, and Vision insuranceLife Insurance and Disability Program: 100% covered by Bionova.Retirement Plan (401K) Up to 8% of Employer MatchPaid time off up to two weeks10 days of Holidays and 5 days of Sick Leave.*As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.*Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us.As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career.**About Asahi Kasei**The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age.With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In North America, Asahi Kasei currently has over 23 business units and 10,000 employees.**Our People**Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within the Material, Homes, and Health Care sectors allows employees to collaborate across locations and industries. The possibilities for employees will continue to grow as we accelerate new business activity internally and externally through mergers and acquisitions.Setup job alerts by selecting ***Sign In***, located in the upper right of the page, to create an account.

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