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This role performs routine supplier quality activities, supports incoming material disposition, coordinates third-party testing activities, maintains associated quality records, and assists with supplier quality investigations under the guidance of Supplier Quality leadership. COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine.

Humacyte Inc

Supplier Quality Specialist

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FULL_TIME

Avance Care is seeking an experienced Advanced Practice Provider (Nurse Practitioner or Physician Assistant) for an exciting opportunity to grow your career in a role that offers both meaningful patient connection and broader organizational impact. If you’re looking for a role where you can care for patients, influence meaningful change, and grow as a clinical leader, we invite you to join Avance Care and be part of the future of high-quality, data-driven healthcare.

Avance Care

Clinical Quality Specialist (Nurse Practitioner/ Physician Assistant)

[AW]-iCims

Provides oversight and approval of laboratory system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.

FUJIFILM Biotechnologies USA Inc

QA Specialist, QC Compliance

When you join Guerbet, you: Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, Are joining a company where we value diversity of talents coming from various horizon. The QA Systems Specialist collaborates with cross-functional teams, including Manufacturing, Quality Control, Supply Chain, Engineering, and Regulatory Affairs, to maintain product quality, compliance, and operational excellence.

GUERBET

QA Systems Specialist

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Guerbet SA

You will provide strategic and technical support for the site's cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Manual requirements. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Seqirus

Specialist I /II / III, QA

QA Specialist (Biotech) duties: o Responsible for performing inspection and disposition of raw materials and components by: o Supporting incoming material release activities within the ERP system, ensuring compliance with applicable regulations and internal procedures. o Conduct thorough reviews of logbooks and Work Orders across Manufacturing, Engineering, Quality, and Warehouse departments to ensure entries are complete, accurate, and compliant with company policies and procedures.

Globalchannelmanagement

Biotech QA Specialist

Your background: Bachelor''s degree in technical, engineering, quality management and a minimum of 5+ years of construction quality site experience OR High School Diploma / GED and a minimum of 9+ years of construction quality site experience. Ensure that the quality control plans (ITP, ITR etc.) and any erection documentation (isometrics, procedures, etc.) provided by HVDC are effectively communicated to the site management team and the contractors.

Hitachi Ltd

Site Quality Specialist - NECEC

Senior Specialist, Quality Systems & Compliance, reporting to the Senior Manager, Quality Systems and Compliance, will support Supplier Quality Management Program activities including managing vendor changes, supplier complaints, quality agreements and ensuring resolution of issues related to external vendors. Supports the preparation, execution, and follow up activities related to Pre-Approval and regulatory inspections including compiling / reviewing documents, policies and procedures to ensure audit readiness, inspection readiness training, management of mock inspections, and management of inspections.

Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the Americas and employs nearly 3,000 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.

Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created two initiatives to demonstrate our commitment: Changing Tomorrow Day, an annual, worldwide volunteer event, and Science WoRx, a nationwide mentoring program and online resource network for science teachers and their students.

Astellas Pharma Inc

Specialist Quality Systems & Compliance

After making a conditional offer and running a background check, if Eaton is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. In this function you will: Assist in quality audits, workmanship defect reduction efforts, corrective and preventive action identification, analysis and reporting, inspection of returned units, special inspections.

HOUR

Eaton is a power management company with 2016 sales of $19.7 billion. We provide energy-efficient solutions that help our customers effectively manage electrical, hydraulic and mechanical power more efficiently, safely and sustainably. Eaton is dedicated to improving the quality of life and the environment through the use of power management technologies and services. Eaton has approximately 95,000 employees and sells products to customers in more than 175 countries. For more information, visit <a href="http://www.eaton.com/Eaton/index.htm" target="_blank">Eaton.com.</a>

Eaton Corporation Plc

Quality Specialist - 1st Shift

This position partners with Engineering, Facilities, Validation, Manufacturing, MSAT, IT, and other cross-functional teams to provide science- and risk-based Quality oversight and ensure facilities, utilities, equipment, systems, and validated processes remain compliant and in a state of control throughout their lifecycle. Support cleaning validation activities including validation strategies, protocols/reports, risk assessments, sampling plans, acceptance criteria, worst-case assessments, hold-time studies, and lifecycle management.

KBI Biopharma Inc

QA Specialist II, Validation

This position partners with Engineering, Facilities, Validation, Manufacturing, MSAT, IT, and other cross-functional teams to provide science- and risk-based Quality oversight and ensure facilities, utilities, equipment, systems, and validated processes remain compliant and in a state of control throughout their lifecycle. The Senior QA Specialist provides Quality Assurance oversight and support for Facilities, Engineering, Validation, Cleaning Validation, Metrology, computerized systems, and related GMP activities supporting clinical and commercial manufacturing operations.

Senior QA Specialist, Facilities & Compliance

Minimum 2 years relevant work experience in Incoterms knowledge, customer experience success, project execution, and supply chain, OR Associate degree in Engineering or related field PLUS minimum 4 years relevant work experience OR High School Diploma/GED PLUS 6 years of relevant work experience. In this role as Customer Quality Specialist , you will have the opportunity to support the deployment of the quality strategy for a local organizational unit, including quality culture, systems, tools, and skilled teams with the aim to satisfy customer expectations, while ensuring sustainable operations.

ABB is a global technology leader in electrification and automation. We see our purpose as being to enable a more sustainable and resource-efficient future. By connecting our engineering and digitalization expertise, we help industries run at high performance, while becoming more efficient, productive and sustainable so they outperform. We call this: ‘Engineered to Outrun.’ We have around 110,000 employees worldwide and a history that stretches back more than 140 years.

Customer Quality Specialist

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KBI Biopharma

This role will be responsible for collaborating with Operations teams on completion of thorough and robust manufacturing investigations, implementation of effective corrective/preventative actions, and manufacturing change controls. The individual is responsible for working cross-functionally with the Manufacturing, Engineering, Supply Chain, IT, QC and other key departments to ensure manufacturing operations are compliant with GxP requirements.

QA Specialist II - Deviations & CAPAs

When you join Guerbet, you: Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, Are joining a company where we value diversity of talents coming from various horizon. Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.

Manufacturing QA Specialist - 2Nd Shift

Manufacturing QA Specialist

About the Job: The Senior Specialist, Quality Assurance Laboratory Operations leverages skill in efficient, regulation-adherent processes, assessments, and process improvements to further improve quality functions, formalized procedures, operations, and systems. Key Responsibilities: Assist in all aspects of the full operation, implementation, and maintenance of the Quality Management System (QMS) to ensure continued compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA), College of American Pathologists (CAP), and the FDA.

YEAR

Foundation Medicine Inc

Senior QA Specialist, Laboratory Operations

ADAPTED_NOW

Fujifilm

Fujifilm-icims

All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration.

Quality Specialist Jobs in Chapel Hill, NC

Supplier Quality Specialist Humacyte Inc

Clinical Quality Specialist (Nurse Practitioner/ Physician Assistant) Avance Care

QA Specialist, QC Compliance FUJIFILM Biotechnologies USA Inc

QA Systems Specialist GUERBET

QA Systems Specialist Guerbet SA

Specialist I /II / III, QA Seqirus

Biotech QA Specialist Globalchannelmanagement

Site Quality Specialist - NECEC Hitachi Ltd

Specialist Quality Systems & Compliance Astellas Pharma Inc

Quality Specialist - 1st Shift Eaton Corporation Plc

QA Specialist II, Validation KBI Biopharma Inc

Senior QA Specialist, Facilities & Compliance KBI Biopharma Inc

Customer Quality Specialist ABB

QA Specialist II, Validation KBI Biopharma

QA Specialist II - Deviations & CAPAs KBI Biopharma Inc

Manufacturing QA Specialist - 2Nd Shift GUERBET

Manufacturing QA Specialist GUERBET

Senior QA Specialist, Laboratory Operations Foundation Medicine Inc

QA Specialist, QC Compliance Fujifilm

QA Specialist, Drug Substance Manufacturing Operations FUJIFILM Biotechnologies USA Inc

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