UNKNOWN

FEED

YEAR

Assess supplier change notifications and quality records to determine their impact on raw materials, processes, and product quality, coordinating with Supplier Quality, Materials Management, Quality Control, and Manufacturing. In this role, you’ll ensure every change to a raw material or component is assessed, documented, and implemented correctly, and you’ll manage supplier-related non-conformances and CAPAs through closure.

Flexible & Integrated Technical Services, LLC

Supplier Quality Specialist

partner JazzHR

Preferred qualifications: GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures. We connect skilled professionals with leading companies in regulated industries, including pharmaceutical, biotech, medical device, and manufacturing.

Quality Assurance Specialist

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience or High school/GED + 10 years of directly related experience.

Validation & Engineering Group, Inc

Specialist QA

clearcompany

Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible.

Quality Specialist- 02

Review and approve assigned qualification lifecycle documents, as applicable, including System Level Impact Assessments, User Requirements Specifications, Criticality or Critical Aspects Risk Assessments, Functional and Design Specifications, Validation Plans, Requirements Traceability Matrices, protocols, discrepancy reports, interim reports, and validation or qualification summary reports. Applicable documents may include GxP assessments, User Requirements Specifications, Validation Plans, vendor assessments, electronic data compliance assessments, Functional Specifications, functional risk assessments, design or configuration specifications, IQ OQ and PQ test scripts, discrepancy reports, Requirements Traceability Matrices, Validation Summary Reports, and system release documentation.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and an annual site shutdown Flexible work models where possible. In this vital role you will will serve as a Quality leader accountable for the investigation and resolution of major deviations, safeguarding product quality and patient safety through sound judgment, strong ownership, cross‑functional collaboration, and effective risk management in a dynamic drug product manufacturing environment.

At Amgen, we believe in a “biology first” approach. We use cutting-edge science and technology to study the subtlest biological mechanisms in search of therapies that will improve the lives of those who suffer from serious diseases. Amgen believes the cure for disease can be found inside each and every one of us.

Amgen Inc

Specialist Quality Assurance - Major Deviations

Packaging/inspection operations, strong knowledge of GDP and electronic quality systems, and the ability to collaborate effectively with Manufacturing, Engineering, and Process Development. Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent.

FULL_TIME

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Sampling Collection & Environmental Monitoring Perform sample collection and quality monitoring oversight of PR05 Utilities Systems (e.g., water systems, steam, compressed gases) and the Environmental Monitoring Program (e.g., room air – viable and non-viable, contact plates).

Mentor Technical Group

Quality Assurance Specialist – Utilities & Environmental Monitoring

HOUR

Attends client's GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation. QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team.

Quality Consulting Group

SPECIALIST QA

Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. T he Personality Part: Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work.

Sr Specialist QA

Provides leadership and guidance to cross-functional, multilevel technical teams to ensure that causes of non-conformance are identified and understood, and that sound corrective/preventive actions are implemented. Bachelor’s Degree in Engineering or related field and at least four (4) years of previous exposure to Audit Observations, Investigations & CAPA activities within the regulated industry.

Quality Engineer/Specialist

Bachelor's degree in Science, Engineering, or a related field (or equivalent); 2–4 years of experience in Quality Assurance within a regulated industry (pharmaceutical, biotech, or medical device). If this sounds like you, and if you commit to serving customers with high-quality research and products, embracing a diverse work culture, and even the environment, you might just be what we’re looking for!

QA Complaints Specialist

Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications. QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team.

JT678 - QUALITY APPLICATIONS SPECIALISTS

JOB SUMMARY: Supervise and lead Document Control Team Member in day to day administration actives of key quality system processes such as; overall documentation support, change control, training, CAPA, complaint processes, internal/external audits support, environmental control and Quality Management Review. Write protocols and reports for Sterilization and/or Microbiological Validation, completes associated paperwork to ensure proper execution (protocol checklists, laboratory submission forms, etc.), interacts with customers as needed.

Viant Medical LLC

Quality - Quality Compliance Supervisor

Bachelor’s degree in Engineering (Chemical, Biotechnical, Biomedical, or Mechanical) and at least five (5) years of experience in automated bulk pharmaceutical GMP operations (Production, Engineering, QA, or Technical Services), with understanding of facilities, utilities, maintenance, commissioning & qualification, and quality systems. For Senior Quality Engineering Specialist services in the Quality Assurance / QA Engineering (FUME: Facilities, Utilities, Maintenance & Engineering) area.

Quality Engineer

From powerful POS systems to seamless online and mobile payment solutions, we equip merchants with the tools they need to succeed in today's fast-moving commerce landscape. If you are energized by building relationships, solving real business problems, and creating opportunities for yourself and your clients, Payroc is the kind of place where you can make an impact and grow your career.

Payroc LLC

Specialist I, File Build (Implementation Specialist)

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation Specialist

The role provides technical leadership for contamination control, environmental monitoring, microbiological laboratory testing, cleanroom qualification, and sterility assurance activities to support product quality, Quality and Regulatory compliance across manufacturing and laboratory operations. Collaborate with Quality, Operations, Engineering, and other cross-functional teams to conduct GEMBA walks, execute Quality Risk Management activities (including FMEA), support audits and inspections, and advance continuous improvement initiatives.

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

Danaher Corp

Contamination Control and Sterility Assurance Sr. Specialist

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. Coordinate technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues and process maintenance issues.

Pinnaql

Specialist Tech Engineering

Develop, revise, execute, and close applicable lifecycle documents, including GxP and electronic records assessments, Validation Plans, User Requirements Specifications, Functional or Design Specifications, risk assessments, supplier assessments, test protocols or scripts, Requirements Traceability Matrices, discrepancy records, Validation Summary Reports, and release documentation. Scope of Work: The assigned qualification resource shall perform the following activities for each system or equipment item included in the approved assignment: Review the applicable User Requirements Specification, design documents, drawings, vendor manuals, commissioning records, calibration records, certificates, approved risk assessments, and other available lifecycle documents.

Quality Specialist Jobs in Puerto Rico

Supplier Quality Specialist Flexible & Integrated Technical Services, LLC

Quality Assurance Specialist Flexible & Integrated Technical Services, LLC

Specialist QA Validation & Engineering Group, Inc

Quality Specialist- 02 Flexible & Integrated Technical Services, LLC

Quality Assurance Specialist Validation & Engineering Group, Inc

Specialist Quality Assurance - Major Deviations Amgen Inc

Specialist QA Flexible & Integrated Technical Services, LLC

Quality Assurance Specialist – Utilities & Environmental Monitoring Mentor Technical Group

SPECIALIST QA Quality Consulting Group

Sr Specialist QA Flexible & Integrated Technical Services, LLC

Quality Engineer/Specialist Flexible & Integrated Technical Services, LLC

QA Complaints Specialist Flexible & Integrated Technical Services, LLC

JT678 - QUALITY APPLICATIONS SPECIALISTS Quality Consulting Group

Quality - Quality Compliance Supervisor Viant Medical LLC

Quality Engineer Flexible & Integrated Technical Services, LLC

Specialist I, File Build (Implementation Specialist) Payroc LLC

Validation Specialist Validation & Engineering Group, Inc

Contamination Control and Sterility Assurance Sr. Specialist Danaher Corp

Specialist Tech Engineering Pinnaql

Computer System Validation Specialist Validation & Engineering Group, Inc

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