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Job DescriptionCompany Description Veolia in North America is the top-ranked environmental company in the United States for three consecutive years, and the country’s largest private water operator and technology provider as well as hazardous waste and pollution treatment leader. It offers a full spectrum of water, waste, and energy management services, including water and wastewater treatment, commercial and hazardous waste collection and disposal, energy consulting and resource recovery. Veolia helps commercial, industrial, healthcare, higher education and municipality customers throughout North America. Headquartered in Boston, Veolia has more than 10,000 employees working at more than 350 locations across North America. Job Description Student Exploration and Experience Development (SEED) is a 12-week internship opportunity at Veolia for students to gain hands-on experience in sustainability and ecological transformation. They will work on real-world projects, receive mentorship from industry professionals, and participate in workshops and networking events. The program aims to nurture talent, promote innovation, and foster meaningful connections between students and industry professionals. Overall, the SEED program provides students with the skills, knowledge, and connections needed to make a positive impact in the industry. Program Dates: June 1, 2026 to August 21, 2026. Position Purpose: Internships at Veolia: We are seeking a motivated and detail-oriented Junior Technical Project Management Intern to join our IT department for the summer. This internship provides an excellent opportunity to gain hands-on experience in project management within a dynamic IT environment. Primary Duties/Responsibilities: • Assist senior technical project managers in planning, executing, and closing software development and IT infrastructure projects using both Waterfall and Agile methodologies., • Help create and maintain technical project documentation, project plans, and change management documentation., • Participate in requirements gathering sessions, technical review meetings, and status updates with stakeholders and Agile ceremonies., • Assist in tracking development progress and project metrics using JIRA and Smartsheets., • Help identify and communicate technical risks, dependencies, and compliance issues to project stakeholders., • Support coordination between development teams, business analysts, and QA teams., • Assist in preparing technical presentations and status reports for steering committee meetings., • Maintain project control documents including risk registers, issue logs, and decision logs., • Ensure project deliverables align with established IT governance frameworks and organizational standards., • Learn and apply both Waterfall and Agile project management methodologies., • Environments vary by internship function from office to field to plant., • Our aim is to provide tangible industry job experience to each intern.Qualifications Education/Experience/Background: • High School Diploma/GED is required., • Working towards a four year degree and you have Senior status in Computer Science, Information Technology, Data Science, or a related major., • Strong communication skills, including written, verbal, listening, presentation and facilitation skills., • Demonstrated ability to build collaborative relationships., • Strong interest in project management and IT., • Excellent organizational and time management skills., • Proficiency in Google Apps (Google Sheets and Slides) or Microsoft Office Suite (especially Excel and PowerPoint)., • Basic understanding of project management concepts and methodologies., • Familiarity with IT concepts and terminology., • Ability to multi-task and prioritize in a fast-paced environment. Additional Information Pay Range: $21.00 to $25.00 per hour. We are an Equal Opportunity Employer! All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. The Company reserves the right to modify this information at any time, subject to applicable law.

The Director of Quality Assurance & Quality Control (QA/QC) is a critical leadership role responsible for ensuring that all manufacturing processes and products meet regulatory, food safety, and internal quality standards. This position oversees the development, implementation, and continuous improvement of comprehensive QA, QC, and food safety systems that protect product integrity, consumer health, and the company’s reputation for excellence. The Director leads quality teams across inspection, testing, audits, and compliance programs while partnering closely with production, engineering, supply chain, and regulatory teams to drive continuous improvement and risk mitigation. This role ensures adherence to Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), ISO standards, and applicable federal, state, and customer requirements across all manufacturing sites in the United States.*Food Safety – Flavors Only Essential Job Functions: • Lead the development, implementation, and continuous improvement of quality assurance, quality control, and food safety systems in compliance with FDA, USDA, ISO, HACCP, GMP, and other applicable regulatory and customer standards., • Manage and conduct internal, external, and third-party audits and inspections, including SQF, BRC, FSSC 22000, ISO 9001, and customer audits., • Oversee inspection, testing, and monitoring of raw materials, in-process components, and finished products to ensure compliance with specifications and quality standards., • Investigate quality issues, non-conformances, deviations, and customer complaints; implement effective corrective and preventive actions (CAPA)., • Collaborate with production, engineering, and supply chain teams to monitor critical control points, improve processes, and reduce defects and waste., • Lead and mentor QA/QC staff, providing training on quality standards, food safety practices, regulatory requirements, and inspection techniques., • Manage supplier quality programs, including supplier audits, performance monitoring, and continuous improvement initiatives with vendors., • Maintain accurate and compliant documentation, records, and traceability within quality management systems (QMS)., • Analyze quality data, KPIs, and trends using statistical and root-cause analysis tools to drive continuous improvement initiatives., • Stay current on regulatory changes, industry trends, and emerging risks to proactively update policies, procedures, and training programs., • Bachelor’s degree in food science, Microbiology, Chemistry, Engineering, Quality Management, or a related field., • Minimum of 8 years of experience in quality assurance, quality control, and/or food safety within a manufacturing environment., • Strong knowledge of food safety and quality systems, including FDA, USDA, HACCP, GMP, ISO 9001, and relevant third-party certifications., • Proven experience managing audits, compliance programs, and quality teams., • Proficiency in quality tools and methodologies such as root cause analysis, CAPA, statistical process control (SPC), and Six Sigma., • Professional certifications such as Certified Quality Auditor (CQA), Certified Food Safety Manager (CFSM), ASQ Certified Manager of Quality/Organizational Excellence, or similar., • Experience with Lean Manufacturing, Six Sigma, or continuous improvement frameworks., • Advanced degree in Food Science, Quality Management, or a related discipline., • Experience working in a multi-site manufacturing environment., • Familiarity with environmental health and safety (EHS) and OSHA requirements. This role requires strong analytical skills to interpret inspection, audit, and production data and identify risks or improvement opportunities. Effective leadership and communication skills are essential for managing QA/QC teams, leading audits, and collaborating across departments. Technical expertise in regulatory frameworks, food safety principles, and quality standards supports compliant and efficient operations. Problem-solving and continuous improvement skills enable the Manager to reduce defects, improve processes, and enhance overall operational excellence. Physical Demands: Must be physically able to operate a variety of machines which includes a computer, printer, typewriter, facsimile machine, copy machine, calculator, telephone, laboratory equipment, etc. While performing the duties of this job, the employee may handle hazardous chemicals in the laboratory. The employee will be required to wear all appropriate Personal Protective Equipment (PPE) including but not limited to eye protection, gloves, and lab coat. The noise level in the work environment is moderate. Physical demands vary from sedentary to moderately active work to include standing, walking, and reaching for prolonged periods of time, not to exceed 8 hours for any given activity. Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee occasionally works near moving mechanical parts, precarious places and is occasionally exposed to risk of electrical shock. The noise level in the work environment is usually moderate to loud. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Environmental, Health & Safety management system (per ISO 14001 and ISO 45001 standards’ requirements) is established at TAKUS. These systems are continually improved to maintain high standards for both a healthy and safe work environment and the protection of the environment. Every worker in the workplace needs to take account the following while carrying out their work activities: 1) think not only of their own health and safety, but also the health and safety of others; 2) consistently apply environmental considerations to prevent adverse effects to the environment; 3) strictly follow compliance and other obligations, while understanding the consequences of not following them. Salary Range is 135K - 175K

Job DescriptionBenefits: • 401(k), • 401(k) matching, • Bonus based on performance, • Dental insurance, • Health insurance Title: Mechanical Engineer Entry Level Reports To: Works under the Lead Engineer Position Summary As a Mechanical Engineer 1 within our R&D / Engineering team, you will design parts, assemblies, and fixtures for new and revised products under the supervision of a Senior or Lead Engineer. You will collaborate with cross-functional engineering teams to support product development, system integration, flow systems, and electrical control solutions for industrial applications. This role is ideal for a hands-on engineer eager to learn, contribute, and grow in a fast-paced and innovative environment. Essential Functions • Design, develop, and analyze technical products and systems under the supervision of lead engineers, • Set up and conduct experimental and performance testing for new or existing products (under supervision), • Maintain accurate records of all experimental and performance tests, • Create and update product documentation, • Create or modify Bills of Materials (BOMs) for new or custom products, • Review and release Engineering Change Notices (ECNs), • Apply fundamental engineering principles during assembly trials for evaluation and design feedback, • Assist in constructing and debugging prototypes and simple assembly fixtures, • Troubleshoot printed circuit boards (PCBs) and control systems, • Collaborate with QA to develop and maintain procedures in compliance with ISO standards, • Work in a team environment to analyze customer requirements and develop custom solutions, • Follow all established safety guidelines and company procedures, • Perform additional duties as assigned, • Bachelors degree in Mechanical Engineering or a closely related field, • Minimum 3 years of experience in a mechanical/electronic engineering environment, • Proficiency in SolidWorks or similar MCAD software (required), • Familiarity with PDM environments and 3D printing software (preferred), • Experience with inspection and/or 3D scanning equipment (preferred), • Working knowledge of Altium or similar PCAD software (preferred), • Proficiency in Microsoft Office Suite and standard communication tools, • Strong statistical data analysis and problem-solving skills, • Ability to use measuring devices and hand tools, • Basic experience with machining equipment (preferred), • Ability to effectively report progress and issues through dashboards, • Strong teamwork skills and collaborative mindset, • Excellent verbal communication and presentation skills, • Eagerness to learn and develop new technical skills, • Adaptability and flexibility in a dynamic, fast-paced environment, • Able to lift at least 30 lbs.

Job DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements, • Travel may be requiredREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Assurance Manager (Compliance)Allendale, NJ The Manager, Quality Assurance manages the PPU support unit services of the QA Department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. • The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes., • Start-up Compliance arm of the Quality Assurance Department., • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality AgreementsREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Travel may be required, • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential

Job DescriptionCompany Description For More Open Positions Visit us at: Our Mission WOONGJIN, Inc. is a rapidly growing team who provides a range of unique, exceptional, and enhanced services to our clients. We have a strong moral code that includes the service of goodness without expectations of reward. We are motivated by the sense of responsibility and servant leadership. Benefits • Medical Insurance, • Vision Insurance, • Dental Insurance, • 401(k), • Paid Sick hoursJob Description We have established internal Development and Operations teams who are eager to adopt this technology, but we need an experienced OutSystems Platform Architect to lead the way. As the "conductor" of this transition, you will not just be building apps; you will lay the foundational architecture, establish enterprise-wide governance, and serve as the primary mentor for our internal teams. If you are passionate about standardizing low-code environments, preventing technical debt, and upskilling traditional developers, this is the perfect role for you. Key Responsibilities • Platform Architecture & Governance: Design and implement a scalable, enterprise-grade architecture using the OutSystems 4-Layer Canvas methodology. Establish coding standards, naming conventions, and UI/UX guidelines to prevent "spaghetti architecture.", • Migration Strategy & Integration: Lead the strategy for migrating complex legacy business logic to OutSystems. Design secure and efficient integrations with external databases, third-party APIs (REST/SOAP), and build custom C#/.NET extensions using Integration Studio when out-of-the-box features are insufficient., • CI/CD & DevOps Collaboration: Work closely with our internal Operations team to configure and manage deployment pipelines (Dev, QA, Prod) via OutSystems LifeTime. Establish robust release management and version control policies., • Team Mentorship & Code Review: Act as the subject matter expert and mentor for our internal Development and Ops teams who are new to OutSystems. Conduct regular code reviews, monitor the Architecture Dashboard, and ensure the team adheres to best practices. Qualifications • Experience: 10+ years of experience in software engineering, with at least 5+ years of hands-on experience designing and delivering enterprise solutions specifically on the OutSystems platform., • Certifications: Active OutSystems Architecture Specialist certification (or proven equivalent architectural experience)., • Technical Skills: * Strong proficiency in relational database design and SQL query optimization (SQL Server, Oracle, etc.)., • Hands-on experience with C# and .NET for building custom OutSystems extensions., • Solid understanding of modern web technologies (HTML, CSS, JavaScript)., • Work Arrangement: Must be located in New Jersey or the Greater NYC area with the ability to reliably commute to our [Ramsey, NJ] office [5 days a week / 3 days a week]., • OutSystems Professional or Expert Developer certifications., • Experience setting up or leading a Low-Code Center of Excellence (CoE)., • Strong understanding of enterprise IT infrastructure and security protocols (SSO, Active Directory, OAuth). Additional Information All your information will be kept confidential according to EEO guidelines. * NO C2C *

Job DescriptionSr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionCompany Description Location: Ridgefield Park Contract Period : 7 week Pay rate: $8,600/M DOE Lead cross-functional development teams building enterprise-grade distributed systems. Manage the full project lifecycle for microservices, API integrations, and DevOps initiatives. Gather business requirements, translate them into functional specifications, and ensure comprehensive documentation and smooth project handovers. Job Description • Requirements & Business Analysis: Conduct stakeholder interviews and user workshops; create BRDs, FRDs, user stories, and acceptance criteria; manage requirements traceability and obtain sign-offs, • Project Planning & Execution: Develop project plans, WBS, and schedules; manage scope, budget, and resources; coordinate releases across environments, • Team Leadership: Lead Java developers, DevOps engineers, QA, and DBAs; facilitate Agile ceremonies; remove blockers and maintain team velocity, • Stakeholder Communication: Serve as liaison between technical teams and business; deliver executive reports and presentations; manage expectations and escalations, • Documentation: Maintain project documentation, meeting minutes, and decision logs; create process flows, SOPs, and user guides, • Project Handover: Develop handover packages, runbooks, and troubleshooting guides; conduct knowledge transfer sessions; obtain formal acceptance, • Technical Coordination: Oversee microservices, CI/CD pipelines, containerization (Docker/Kubernetes), database migrations, and monitoring implementationsQualifications Experience: • 7+ years project management in software development; 5+ years with enterprise Java/API/distributed systems, • 3+ years Agile/Scrum in DevOps environments; 3+ years business analysis and requirements gathering, • Microservices architecture, RESTful APIs, Spring Boot ecosystem, message brokers (Kafka/RabbitMQ), • CI/CD pipelines (Jenkins/GitLab CI), Docker, Kubernetes, Linux environments, • Exceptional communication, presentation, and facilitation skills for technical and non-technical audiences, • Strong technical writing; proficient in creating BRDs, FRDs, process flows (Visio/Lucidchart/Miro), • BS/BA in Computer Science, IT, or Business Administration, • Previous experience as developer, BA, or technical lead; cloud platforms (AWS, Azure, GCP), • ITIL certification; experience with UAT coordination, change management, and organizational transformation Additional Information All your information will be kept confidential according to EEO guidelines.

Job DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionCompany Description For More Open Positions Visit us at: Our Mission WOONGJIN, Inc. is a rapidly growing team who provides a range of unique, exceptional, and enhanced services to our clients. We have a strong moral code that includes the service of goodness without expectations of reward. We are motivated by the sense of responsibility and servant leadership. Benefits • Medical Insurance, • Vision Insurance, • Dental Insurance, • 401(k), • Paid Sick hoursJob Description JOB SUMMARY Lead cross-functional development teams building enterprise-grade distributed systems. Manage the full project lifecycle for microservices, API integrations, and DevOps initiatives. Gather business requirements, translate them into functional specifications, and ensure comprehensive documentation and smooth project handovers. KEY RESPONSIBILITIES • Requirements & Business Analysis: Conduct stakeholder interviews and user workshops; create BRDs, FRDs, user stories, and acceptance criteria; manage requirements traceability and obtain sign-offs, • Project Planning & Execution: Develop project plans, WBS, and schedules; manage scope, budget, and resources; coordinate releases across environments, • Team Leadership: Lead Java developers, DevOps engineers, QA, and DBAs; facilitate Agile ceremonies; remove blockers and maintain team velocity, • Stakeholder Communication: Serve as liaison between technical teams and business; deliver executive reports and presentations; manage expectations and escalations, • Documentation: Maintain project documentation, meeting minutes, and decision logs; create process flows, SOPs, and user guides, • Project Handover: Develop handover packages, runbooks, and troubleshooting guides; conduct knowledge transfer sessions; obtain formal acceptance, • Technical Coordination: Oversee microservices, CI/CD pipelines, containerization (Docker/Kubernetes), database migrations, and monitoring implementationsQualifications Experience: • 7+ years project management in software development; 5+ years with enterprise Java/API/distributed systems, • 3+ years Agile/Scrum in DevOps environments; 3+ years business analysis and requirements gathering, • Microservices architecture, RESTful APIs, Spring Boot ecosystem, message brokers (Kafka/RabbitMQ), • CI/CD pipelines (Jenkins/GitLab CI), Docker, Kubernetes, Linux environments, • Exceptional communication, presentation, and facilitation skills for technical and non-technical audiences, • Strong technical writing; proficient in creating BRDs, FRDs, process flows (Visio/Lucidchart/Miro), • BS/BA in Computer Science, IT, or Business Administration, • Previous experience as developer, BA, or technical lead; cloud platforms (AWS, Azure, GCP), • ITIL certification; experience with UAT coordination, change management, and organizational transformation Additional Information All your information will be kept confidential according to EEO guidelines. * NO C2C *

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionIs This You? • Do you spot a defect in seconds and love proving it with crisp documentation?, • Do you enjoy collaborating with suppliers to keep materials compliant?, • Inspect inbound goods against defined specifications and acceptance standards., • Record and report nonconformances, defects, and discrepancies immediately., • Partner with suppliers to resolve issues and ensure ongoing compliance., • Conduct periodic audits of receiving processes to maintain quality rigor., • Assist in creating, refining, and implementing QA protocols., • Keep thorough inspection records and quality assessment documentation., • Share insights and best practices during team discussions to improve outcomes.You Have, • High school diploma or equivalent (extra QA education is a plus)., • Background in quality or receiving (preferred)., • Strong attention to detail and sharp observation., • Ability to work independently and contribute in a team setting., • Knowledge of QC methodologies and tools., • Effective written and verbal communication.

Job DescriptionQuality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs.The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. • The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes., • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality AgreementsREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Travel may be required, • Strong business acumen, • Experience with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Key Responsibilities - Craft realistic developer prompts across multiple categories (code review, debugging, error diagnosis, configuration, and more) - Source and adapt content from real PRs to create authentic scenarios - Write clear, technically accurate model responses that demonstrate strong re

Generación de métricas e indicadores de los equipos de QA. Tu principal misión será: * La posición se encargará de liderar al equipo de QA en la ejecución de pruebas para validaciones de los software según corresponda. Realizará la planificación estratégica de algunos proyectos relaciona

Job Description ELLKAY started out providing connectivity solutions to laboratories and within a few years, grew to also provide data management solutions to ambulatory organizations. ELLKAY is now a trusted data management partner in five healthcare segments. ELLKAY’s solutions continue to serve laboratories and ambulatory practices and have expanded to empower hospitals and health systems, healthcare IT vendors, ambulatory practices, health plans, and other healthcare organizations with cutting-edge technologies and solutions that drive their growth and interoperability strategies. Today, ELLKAY remains true to our core values, building strong partner relationships and offering unparalleled service and support while providing innovative, scalable solutions to the challenges our customers face in today’s data-rich world. ELLKAY's experience, customer-focused approach, and reputation for innovation, speed, and accuracy differentiate ELLKAY as a premier partner for your interoperability needs and data management strategy. Job Description: We are seeking an experienced Senior Software Developer – Cloud Technology & Cloud Infrastructure to design, develop, and maintain scalable, secure, and high-performing cloud-based solutions. This role will focus on building cloud-native applications and infrastructure that support healthcare integrations, including EHR and Acute Care systems. The ideal candidate will have deep expertise in cloud platforms, distributed systems, infrastructure automation, and DevOps practices, along with experience integrating with healthcare systems such as Epic, Cerner, MEDITECH, or Allscripts in acute care environments. Essential Duties & Responsibilities: Cloud Architecture & Application Development • Design and develop scalable, cloud-native applications using modern architectures (microservices, event-driven systems)., • Build and maintain APIs and backend services supporting integrations with EHR systems such as Epic, Cerner Millennium, MEDITECH Expanse, Allscripts, or Athenahealth., • Design and manage infrastructure using Infrastructure as Code (IaC) tools such as Terraform., • Implement and manage CI/CD pipelines for automated deployments., • Deploy and manage containerized applications using Docker and Kubernetes., • Ensure high availability, scalability, disaster recovery, and business continuity for healthcare systems., • Design and maintain integrations using healthcare standards such as HL7, FHIR, and APIs., • Ensure solutions comply with healthcare regulations (e.g., HIPAA)., • Provide technical leadership and mentorship to development teams., • Conduct architecture reviews, code reviews, and technical documentation., • Collaborate cross-functionally with DevOps, Security, QA, Product, and Healthcare Integration teams., • Bachelor’s or master’s degree in computer science, Engineering, or related field (or equivalent practical experience)., • 7+ years of software development experience., • 4+ years of hands-on experience with cloud platforms (AWS, Azure, or Google Cloud)., • Strong proficiency in one or more programming languages (Java, Python, C#, Go, or Node.js)., • Experience with:, • Kubernetes and container orchestration, • Infrastructure as Code (Terraform, ARM, CloudFormation), • CI/CD tools (Jenkins, GitHub Actions, Azure DevOps, GitLab CI), • RESTful APIs and microservices architecture, • Knowledge of healthcare data standards such as HL7 and FHIR., • Strong understanding of cloud networking, IAM, encryption, and security best practices., • Cloud certifications such as:, • AWS Certified Solutions Architect, • Microsoft Azure Solutions Architect Expert, • Google Professional Cloud Architect, • Experience with serverless architectures and event streaming platforms (Kafka, Pub/Sub)., • Knowledge of multi-cloud or hybrid-cloud strategies., • Familiarity with Site Reliability Engineering (SRE) practices. ELLKAY offers a comprehensive and competitive benefit package that starts day one! Including: • Medical, Dental, and Vision benefits, • Employer-paid Life and LTD, • 401k w/ matching – once eligibility is met, • Work/life balance, • Paid Volunteer Program, • Flexible working hours, • Generous FTO, • Remote work options, • Employee Discounts, • Working with talented, collaborative, and friendly people who love what they do, • Professional growth within, • Innovation environment At ELLKAY, we are committed to operating as a hybrid workplace, offering employees flexibility in how they structure their time between in-office and remote work. We recognize the significance of fostering connections, collaboration, and creativity within our office culture and its positive impact on our business. Our philosophy of operating as a hybrid workplace underscores our dedication to enabling employees to tailor work-life balance to their individual preferences. For those who do not live within 40 miles of one of our offices, we are open to considering remote work for candidates whose skills and experience strongly align with the role. While we prioritize a hybrid work environment for most roles, we understand the importance of flexibility and are open to remote work for specific positions and specialized skill sets. For more information on our company, visit . ELLKAY LLC is a Smoke-Free Workplace. ELLKAY, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Job DescriptionCompany Description Contract Period: 1/2/2026 – 3/31/2026 Work Location: Ridgefield Park, NJ Pay: $8,682/month Overview: The Business Analyst will work closely with customers to gather, analyze, and document business requirements for system development projects. This role includes process documentation, preparing functional specifications, supporting QA testing, and leading user acceptance testing (UAT). The Business Analyst will also assist with proposal development for new project opportunities. This position requires strong bilingual communication skills in Korean and English, as the role involves frequent collaboration with Korean-speaking stakeholders and documentation in both languages. Job Description • Gather and analyze customer requirements for technology implementation projects, • Conduct interviews and workshops in both Korean and English, • Document functional and technical requirements with bilingual clarity, • Develop future-state process documentation and detailed functional specifications, • Facilitate meetings and presentations with stakeholders in Korean and English, • Prepare UAT test cases and support customers during user acceptance testing, • Monitor project deliverables and ensure timely completion, • Provide guidance, training, and support to end users after system deployment, • Support proposal and pre-sales activities when requiredQualifications, • Bachelor’s degree or higher, • 10+ years of experience in system development projects or related fields, • Bilingual fluency in Korean and English (speaking, reading, and writing required), • Strong documentation skills using Excel, Word, and PowerPoint, • Excellent presentation and communication skills, • Proven ability to follow through on commitments and meet deadlines, • Experience supporting or leading short-term system development projects (3–12 months), preferred, • Deep understanding of the Software Development Lifecycle (SDLC), • Ability to travel within the U.S. (30% or more as needed) Additional Information All your information will be kept confidential according to EEO guidelines.

Job DescriptionCompany Description Working Location: Ridgefield Park Contract Period: 02/01/2026 – 04/30/2026 (a decision will be made for the extension after 3 month) Pay rate: $8,600/M DOE Work Hours: 08:30am ~ 17:30pm (subject to changed) The Business Analyst will work closely with customers, developers, and internal project teams to successfully propose, deliver, and support system development projects. This role places a strong emphasis on effective communication, collaboration, and logical thinking, ensuring business requirements are clearly understood, documented, and implemented. Strong bilingual communication skills in Korean and English are essential, as the role involves frequent interaction with Korean-speaking stakeholders and cross-functional technical teams. Job Description Communication & Stakeholder Engagement (Top Priority) • Communicate directly with customers to understand business needs, clarify requirements, and manage expectations, • Act as a bridge between customers and development teams to ensure clear and consistent communication, • Collaborate closely with project managers, developers, QA teams, and customers, • Respect diverse perspectives and actively participate in constructive discussions, • Gather, analyze, and validate requirements for IT and system development projects, • Quickly understand and adapt to new systems, tools, and technologies, • Support the full system development lifecycle, from requirements analysis through deployment, • Apply logical and structured thinking to analyze business requirements, • Document functional and technical requirements with clarity in both Korean and English, • Develop future-state process documentation and detailed functional specifications, • Provide training, guidance, and post-deployment support to end users, • Support proposal development and pre-sales activities when requiredQualifications Communication & Collaboration • Excellent communication skills with both customers and technical teams, • Ability to clearly explain complex ideas, requirements, and system behaviors, • Bachelor’s degree or higher, • 10+ years of experience in IT or system development projects, • Ability to quickly adapt to new systems, technologies, and project environments, • Solid understanding of the Software Development Lifecycle (SDLC), • Strong logical thinking and problem-solving abilities, • Excellent documentation skills using Excel, Word, and PowerPoint, • Bilingual fluency in Korean and English (speaking, reading, and writing required), • Ability to travel within the U.S. (30% or more as needed) Additional Information All your information will be kept confidential according to EEO guidelines.

Job DescriptionCompany Description WOONGJIN INC. is looking for a Business Analyst who will be a vital link between the business requirement and our Web system implementation by supporting and analyzing the business process, testing and executing deployment tasks of our system features. This position needs to coordination among the business team, UX team, tech team and all related groups. WOONGJIN INC. is a rapidly growing team who provides a range of unique, exceptional, and enhanced services to our clients. We have a strong moral code that includes the service of goodness without expectations of reward. We are motivated by the sense of responsibility and servant leadership. Job Description The Business Analyst will work closely with customers, developers, and internal project teams to successfully propose, deliver, and support system development projects. This role places a strong emphasis on effective communication, collaboration, and logical thinking, ensuring business requirements are clearly understood, documented, and implemented. Communication & Stakeholder Engagement (Top Priority) • Communicate directly with customers to understand business needs, clarify requirements, and manage expectations, • Act as a bridge between customers and development teams to ensure clear and consistent communication, • Collaborate closely with project managers, developers, QA teams, and customers, • Respect diverse perspectives and actively participate in constructive discussions, • Gather, analyze, and validate requirements for IT and system development projects, • Quickly understand and adapt to new systems, tools, and technologies, • Support the full system development lifecycle, from requirements analysis through deployment, • Apply logical and structured thinking to analyze business requirements, • Document functional and technical requirements with clarity in both Korean and English, • Develop future-state process documentation and detailed functional specifications, • Provide training, guidance, and post-deployment support to end users, • Support proposal development and pre-sales activities when requiredQualifications Communication & Collaboration • Excellent communication skills with both customers and technical teams, • Ability to clearly explain complex ideas, requirements, and system behaviors, • Bachelor’s degree or higher, • 10+ years of experience in IT or system development projects, • Ability to quickly adapt to new systems, technologies, and project environments, • Solid understanding of the Software Development Lifecycle (SDLC), • Strong logical thinking and problem-solving abilities, • Excellent documentation skills using Excel, Word, and PowerPoint, • Bilingual fluency in Korean and English (speaking, reading, and writing required), • Ability to travel within the U.S. (30% or more as needed) Additional Information All your information will be kept confidential according to EEO guidelines.