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Overview: Join our team as a day shift, full-time Labor & Delivery (L&D) Registered Nurse in Westwood, NJ. Why Join Us? Thrive in a People-First Environment and Make Healthcare Better • Thrive: We empower our team with career growth opportunities, tuition assistance, and resources that support your wellness, education, and financial well-being., • People-First: We prioritize your well-being with paid time off, comprehensive health benefits, and a supportive, inclusive culture where you are valued and cared for., • Make Healthcare Better: We use advanced technology to support our team and enhance patient care., • Learn more about the benefits offered for this job. Get to Know Your Team: • Hackensack Meridian Pascack Valley Medical Center is a 128-bed, full-service, acute-care community hospital with a new emergency department, a state-of-the-art maternity center, a women's imaging center, and an ICU. Responsibilities:, • The RN Staff Nurse functions as a caregiver for a specific patient population in order to achieve desired outcomes., • This position directs and oversees the care provided by other caregivers through delegation, validation, evaluation, and coordination., • This position effectively coordinates patient care/unit activities among nursing peers, physicians and support services., • The RN Staff Nurse reports to the Nurse Manager. Qualifications: Job Requirements: • Registered Nurse (RN) with New Jersey Board of Nursing or an RN Multistate License from the NCL required., • Graduate of an NLN/AACN-accredited program in nursing, • Advanced Cardiovascular Life Support (ACLS) certification, • BLS certification must be obtained within 14 days of hire or transfer into the role and prior to providing direct patient care., • Neonatal Resuscitation Program Certification (NRP) required., • 1-2 years of Labor and Delivery nursing experience required, • Able to complete AWHONN Electronic Fetal Monitoring Course within 6 months of hire. Preferred Job Requirements: • OB nursing certification, • EFM certification Rate of pay is determined based on experience and education and may include other pay components such as differentials and call pay based on role.

Overview Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change. The Registered Nurse functions as a caregiver for a specific patient population in order to achieve desired outcomes. This position focuses on expanding knowledge and skills, provides effective direct care as part of the interdisciplinary team to a variety of complex patients. This position directs and oversees the care provided by other caregivers through delegation, validation, evaluation, and coordination. This position effectively coordinates patient care/unit activities among nursing peers, physicians and support services. Responsibilities A Registered Nurse at Hackensack Meridian Health involves the delivery of nursing practices according to the most up-to-date evidence-based research, nursing policies, and standards of care, to provide and ensure safe and excellent delivery of individualized patient care. A day in the life of a Registered Nurse includes: • Assessment, Planning, Implementation and Evaluation Assessment, • Collects comprehensive data pertinent to the patient's health or the situation., • Performs age and disease specific assessment / data collection independently in a systematic manner focusing on physiologic, psychological and cognitive status., • Recognizes clinical and diagnostic status changes in patient status., • Identifies variables in patient/family education needs based on age, disease, and culturally specific learning differences., • Develops a plan of care that prescribes strategies and interventions to attain expected outcomes., • Formulates age and disease specific patient / family centered goals / outcomes based on assessment data., • Develops and coordinates a plan of care which is patient / family focused, prioritized and encompasses the continuum of care., • Communicates, coordinates, and implements the plan of care., • Provides ongoing communication with patient / family, nursing colleagues and other members of the health care team regarding patient's status, rendered care and treatment plans., • Implements age and disease specific care in an organized and timely manner., • Provides or coordinates the patient / family education as needed and ensures understanding., • Performs according to established protocols in clinical situations, including communicating with appropriate persons and documenting events., • Provides nursing care and treatments that reflect the patients' needs, advocates appropriately and demonstrates evidence-based nursing practice and compliance with standards., • Performs continuous Point-of-Care electronic documentation of each individual patient's assessments, plan-of-care, interventions and evaluation of rendered care., • Medication administration utilizing the newest advancements in bar-scanning and documentation technologies designed to ensure the safest delivery of medications to our patients., • Multi-disciplinary discharging of patients to ensure safe transitioning and continuum of care., • Evaluates progress toward attainment of outcomes., • Utilizes critical thinking skills based on nursing knowledge to achieve desired patient outcomes., • Initiates interventions related to patient's change in condition and unexpected response to care., • Identifies ethical issues in the practice setting and brings them to the attention of other team members., • Recognizes and responds to opportunities to enhance patient satisfaction., • Must acquire and maintain competencies, certifications and continuing education in order to meet any facility accreditation or individual licensing requirements., • Adheres to American Nurses Association Code for Nurses with Interpretive Statements., • Lifts a minimum of 35 lbs., pushes and pulls a minimum of 10 lbs. and stands a minimum of 6 hours a day., • Adheres to HMH's Organizational and Managerial competencies and standards of behavior., • Other duties and/or projects as assigned. Qualifications • A minimum of an associate in Nursing or diploma of Nursing degree., • BSN in progress and/or willing to acquire within three (3) years of hire., • Must have a current and valid Registered Nurse license to work at the assigned HMH location by date of hire. BLS/CPR certification by American Heart Association is required within 60 days of hire. • Must have six (6) or more months of relevant nursing experience OR must be an active participant with Hackensack Meridian Health's Nurse Residency Program., • The ability to learn quickly and adapt to changing patient needs, a strong sense of accountability for improving the lives of our patients and their caregivers, an exceptional focus on teamwork, dedication to ongoing education and the ability and passion to deliver the highest quality of care based on a strong sense of patient focus are all required., • National Certification in area of specialty preferred when eligible. If you feel that the above description speaks directly to your strengths and capabilities, then please apply today! Compensation Minimum rate of $48.18 Hourly HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to: • Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness., • Experience: Years of relevant work experience., • Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training., • Skills: Demonstrated proficiency in relevant skills and competencies., • Geographic Location: Cost of living and market rates for the specific location., • Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization., • Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts. In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits. HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran. Our Network Hackensack Meridian Health (HMH) is a Mandatory Influenza Vaccination Facility All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran. As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.

$35 - $100/hourpayEViewsMacroeconomicsAbout micro1micro1 connects domain experts to the development of frontier AI models. Real-world expertise is turned into training data, evaluations, and feedback loops that improve how models perform. AI labs and enterprises use micro1 to train models and build reliable AI agents through advanced evaluations and reinforcement learning environments. Experts contribute directly to how AI systems learn, reason, and perform across domains like finance, healthcare, engineering, and more. Our platform identifies and vets top talent through an AI recruiter, enabling high-quality contributions at scale.Our goal is to enable 1 billion people to do meaningful work by applying their expertise to AI. We’ve raised $40M+ in funding, and our AI recruiter has powered over 1 million AI-led interviews as our global network of experts grows into the human intelligence layer for AI. Job Title: Macroeconomic Modeling Specialist (EViews) Job Type: Contract Location: Remote Job Summary Join our customer's team as a Macroeconomic Modeling Specialist (EViews) and drive the creation, validation, and automation of advanced macroeconomic models. Leverage your expertise in EViews to develop robust time-series and forecasting solutions, contributing essential economic insights that inform key decisions at the organizational level. This remote opportunity is ideal for a passionate modeler who values clarity in communication and excellence in quantitative analysis. Key Responsibilities • Design and implement sophisticated time-series models such as VAR, VECM, ARIMA, and cointegration frameworks using EViews., • Conduct rigorous model diagnostics and validation to ensure robustness and reliability of forecasts., • Automate forecasting workflows for efficiency and scalability within the modeling process., • Translate complex statistical outputs into clear, actionable macroeconomic insights for both technical and non-technical stakeholders., • Document modeling approaches and results with precise, concise written reports., • Collaborate with the customer's team to integrate modeling results into broader economic narratives and policy recommendations., • Stay current with macroeconomic modeling best practices and EViews software updates. Required Skills and Qualifications • Extensive hands-on experience with EViews, including scripting and automation functionalities., • Proven expertise in building, estimating, and validating time-series models—especially VAR, VECM, ARIMA, and cointegration models., • Deep knowledge of model diagnostics, stability tests, and forecasting accuracy measures., • Strong quantitative background with the ability to explain complex modeling processes in clear written and verbal communication., • Demonstrated success in automating modeling and forecasting workflows., • Ability to extract economic meaning from statistical outputs and present findings insightfully., • Self-driven, detail-oriented, and adept at remote collaboration. Preferred Qualifications • Advanced degree in Economics, Econometrics, Applied Statistics, or related field., • Previous experience supporting central banks, policy institutions, or financial sector clients with macroeconomic modeling., • Familiarity with additional econometric software or programming languages (e.g., R, Python, Stata).

Our company delivers value-added logistics solutions on a global scale through customized approaches that meet our clients’ evolving needs. As we continue to expand our digital capabilities and safeguard our systems, we are currently seeking a highly motivated and experienced system specialist to join our IT team. The IT Systems Analyst will support and maintain Warehouse Management System (WMS), Transportation Management System (TMS), and related logistics systems (including Last Mile Delivery (LMD) system across warehouse and distribution operations. This role is responsible for system operation support, issue analysis, user communication, and coordination with external vendors to ensure stable system performance and business continuity. Roles & Responsibilities 1. System Operation & Support Monitor and support WMS, TMS, and logistics operation systems Analyze user requests and provide initial responses Analyze system errors and identify root causes Respond to critical failures and collaborate with vendors 1. Incident & Change Management Manage system failure tickets and track resolution status Support testing and validation activities, including User Acceptance Testing (UAT) for new logic/features. Conduct impact analysis and communicate with users during system changes 1. Business Process Support Understand warehouse operation processes (Inbound, Outbound, Inventory Control, etc.) Support TMS-related dispatch/transportation processes Compile and document requests for process improvements 1. Documentation Create and update system manuals Prepare incident reports and system improvement documentation Manage documentation for standardized operational processes Requirements & Qualifications • Fluency in Korean and English (written and verbal) preferred, • Bachelor's degree or higher (IT, Computer Science, Industrial Engineering, Logistics-related majors preferred), • 2-5 years of experience operating WMS or TMS or other logistics systems, • Understanding of logistics/warehouse operations systems, • User communication skills, • Experience analyzing system data using SQL is a plus, • Strong sense of ownership and accountability This position is not eligible for employer-sponsored work authorization now or in the future. Applicants must be legally authorized to work in the United States without employer sponsorship.

Responsible for receipt and documentation of Safety information for Marketed and Investigational Products. Interacts with health professionals and consumers to obtain and follow-up reports of possible adverse events with company products. Provides product information to health care professionals, consumers, and sales representatives. Codes and enters information into the global safety database. Verifies the accuracy, completeness and validity of information for each adverse event report for which he/she is responsible. Assures consistency of case records and documentation. Creates and ensures distribution of regulatory reports for FDA and other regulatory health authorities. Accurate and timely data entry of both domestic and foreign adverse event and serious adverse event information into the PSSS (Product Safety Surveillance System) consistent with the ARISg coding manual, SOPs/WIDs, process flows and established time frames within the ARISg workflow. Full understanding of the products’ company Core Data sheet, PI, and/or IB for accurate labeling and listedness. Perform appropriate and timely follow-up per department guidelines, including accurate and thorough communication documentation within the case. Maintain proficiency in the utilization of the PSSS, including MedDRA coding. This may include participating in the validation process for the PSSS. Ensure accurate and timely submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes. Utilize ARISg for all reporting and confirmation of successful distribution and acknowledgement. Maintain sufficient knowledge of all company products to ensure professional and knowledgeable discussions with consumers and healthcare providers and dissemination of accurate product information in response to queries. Provide high level customer service to consumers, health care professionals and internal customers. Complete all required training within the timelines provided so as to ensure knowledge of all relevant corporate and departmental SOP’s, SWP’s and WID’s. Ensure timeliness in regulatory compliance Gather sufficient information to assess the medical significance of an adverse event report, while at the same time assuring the information provided adequately addresses the concerns of the health care provider and/or consumer. Required Qualification & Skills: Bachelor’s degree in Medical field with RN or RPh licensure, or PharmD/MD degree required. Minimum 2 to 4 years in industry application of clinical medicine/pharmacy with a minimum of 1 year in pharmaceutical drug safety Experience in verbally interviewing and/or providing medical information to health care professionals and consumers Application of clinical medicine to patient care Medical terminology and standards of patient care Computer proficiency

Who You Are: The Manager, Strategic Sourcing is responsible for developing and executing sourcing strategies across the Marketing & Advertising category that drive cost savings, improve supplier performance, and ensure category compliance. This role leads sourcing events (RFIs, RFPs, negotiations), monitors the market, and builds supplier relationships. This person may also coach junior sourcing and procurement staff and partner with internal stakeholders to align procurement efforts with business needs. Success requires the ability to manage and prioritize multiple projects / initiatives simultaneously, often across different business units and timelines. What You’ll Do: • Develop multi-year category strategies aligned with business objectives and global strategic sourcing priorities., • Partner with internal stakeholders to establish spend baselines and annual savings targets, ensuring alignment and formal savings validation., • Serve as a procurement subject matter expert, utilizing industry trends, internal spend data, and analytical insights to identify optimization opportunities that support business goals., • Lead the development and execution of sourcing strategies and supplier spend management initiatives, including complex sourcing projects and contract negotiations to maximize value., • Apply advanced analytics and procurement technologies to support data-driven sourcing decisions and uncover cost and efficiency opportunities., • Build strong relationships with key business stakeholders to understand their needs and serve as a trusted advisor for managing spend and supplier relationships., • Foster cross-functional collaboration with IT, Marketing, Advertising, Finance, Operations, HR, Privacy, and Legal to align sourcing initiatives and drive business outcomes., • Ensure compliance with procurement policy, • Manage the resolution of sourcing and supplier-related issues., • Continuously evaluate the market for new suppliers, products, and services to enhance category strategies and deliver maximum value., • Review and negotiate supplier agreements to support the organization’s short-, mid-, and long-term business needs., • Leverage data analytics for cost modeling and total cost of ownership (TCO) analysis to support business cases, sourcing strategies, and negotiations. You’ll Need to Have: • 5–8 years in procurement, category management or strategic sourcing with specific category expertise across social, digital, media, marketing, and advertising services, • Bachelor’s degree in supply chain, finance, business administration, or a related field, • Excellent stakeholder and supplier relationship management, • Experience running competitive bids and managing supplier performance, • Strong negotiation and influencing skills, • Analytical thinking and prioritization, • Proficiency in Excel and sourcing tools (e.g., Ariba, Coupa, spend analytics, CLM, etc.), • Ability to be based in our East Rutherford office with regular travel to our NYC office Capri Perks: • Generous Paid Time Off & Holiday Schedule, • Summer Fridays, • Internal mobility across Versace, Jimmy Choo and Michael Kors, • Cross-brand Discount, • Exclusive Employee Sales, • Fav 5 Cards (MK Discount for friends and family), • 401k Match, • Paid Parental Leave, • Thrive Wellness Program, • Commuter Benefits, • Gym Discounts The Company is an equal employment opportunity employer. The Company’s policy is not to unlawfully discriminate against any applicant or employee on the basis of race, color, sex, sexual orientation, gender identity, religion, national origin, age, military status, disability, genetic information or any other consideration made unlawful by applicable federal, state, or local laws. The Company also prohibits harassment of applicants and employees based on any of these protected categories. At Capri Holdings Limited, we are committed to providing a fair and accessible recruitment process. If you require a reasonable accommodation for the interview or application process, please contact our Talent Acquisition team at CapriTalentAcquisition@CapriHoldings.com. In compliance with certain Pay Transparency laws, employers are required to disclose a salary range. The salary for this position will vary based on role requirements, skill set and years of experience.

Who You Are: The Tableau Developer is a key member of the Data & Analytics team reporting to Director of BI. This role is responsible for designing, developing, and maintaining interactive dashboards and reports using Tableau to support business decision-making. This role partners business stakeholders, data engineers, and analysts to translate complex data into intuitive visual insights while ensuring performance, data accuracy, and best visualization practices. The role will follow Tableau best practices for visualization design, naming conventions, and documentation while also maintaining version control and promoting content across environments (Dev / Test / Prod) On Tableau Cloud. What You'll Do: • Design and develop interactive Tableau dashboards and reports that clearly communicate key business metrics and trends., • Translate business requirements into effective data visualizations using best practices in visual analytics., • Optimize dashboards for performance, scalability, and usability., • Connect Tableau to multiple data sources (e.g., SQL databases, data warehouses, cloud platforms, Excel, APIs)., • Create and maintain data models, joins, calculations, parameters, and filters., • Perform data validation and reconciliation to ensure accuracy and consistency., • Work closely with stakeholders to gather requirements and understand reporting needs., • Provide data-driven insights and recommendations to support strategic and operational decisions., • Conduct user training and enablement sessions when needed., • Monitor dashboard usage and performance., • Troubleshoot data issues, refresh failures, and user access problems., • Enhance and maintain existing dashboards as business needs evolve. You'll Need To Have: • Bachelor’s degree in computer science, Information Systems, Data Analytics, or related field., • 5+ years of Tableau development experience., • Solid understanding of SQL for data querying and validation., • Experience working with relational databases and data warehouses (e.g., Snowflake, Redshift, SQL Server, Oracle)., • Strong knowledge of calculated fields, LOD expressions, table calculations, and parameters., • Strong analytical mindset with attention to detail., • Ability to interpret data and explain insights clearly to non-technical audiences., • Understanding data modeling concepts (facts, dimensions, star schema)., • Excellent communication and stakeholder management skills., • Ability to gather requirements and translate them into technical solutions., • Strong problem-solving and time management skills. We'd Love To See: • Experience with Tableau Cloud administration., • Knowledge of ETL tools like Talend or AWS Glue., • Experience with Python or R for advanced analytics., • Familiarity with Agile / Scrum methodologies., • Tableau certification (Desktop Specialist, Certified Data Analyst, etc.). Capri Perks: • Generous Holiday Schedule & Vacation Days, • Internal mobility across Capri Brands (Michael Kors, Jimmy Choo, Versace), • Cross-brand Discount, • Exclusive Employee Sales, • Fav 5 Cards (MK Discount for friends and family), • 401k Match, • Paid Parental Leave, • Thrive Wellness Program (seasonal in-office massages and more!), • Commuter Benefits, • Gym Discounts CAPRI HOLDINGS is a global fashion luxury group consisting of iconic, founder-led brands Jimmy Choo and Michael Kors. Our commitment to glamorous style and craftsmanship is at the heart of each brand, as we design innovative products across the full spectrum of fashion luxury categories. The unique DNA and heritage of each brand, combined with the diversity and passion of our people, and our dedication to clients and communities, define our success. The Company is an equal employment opportunity employer. The Company’s policy is not to unlawfully discriminate against any applicant or employee on the basis of race, color, sex, sexual orientation, gender identity, religion, national origin, age, military status, disability, genetic information or any other consideration made unlawful by applicable federal, state, or local laws. The Company also prohibits harassment of applicants and employees based on any of these protected categories. At Capri Holdings Limited, we are committed to providing a fair and accessible recruitment process. If you require a reasonable accommodation for the interview or application process, please contact our Talent Acquisition team at CapriTalentAcquisition@CapriHoldings.com. In compliance with certain Pay Transparency laws, employers are required to disclose a salary range. The salary for this position will vary based on role requirements, skill set and years of experience.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. This role supports global projects and financial governance by maintaining plans, risks, and executive reporting, enabling effective governance cadences and creating SharePoint, dashboards, and automation to reduce manual effort. It also supports FinOps by analyzing cloud spend, tracking savings and forecasts, and connecting technical activity to financial impact. 1.Project Management Support • Support program and project managers in maintaining:, • Project plans, milestones, dependencies, and risks, • RAID logs (Risks, Assumptions, Issues, Dependencies), • Action trackers and executivelevel status reports, • Assist with weekly and monthly governance cadence:, • Status consolidation across multiple workstreams, • Preparation of SteerCo / leadershipready summaries, • Track deliverables vs plan and highlight schedule or scope risks early, • Support documentation of processes, RACI models, and operating procedures 1. SharePoint Workflows, Automation & Dashboards (New / Expanded) • Design and maintain SharePoint solutions to support project and financial governance:, • SharePoint Lists for project, action, and cost trackers, • Automated workflows (Power Automate or equivalent) for:, • Status updates, • Approvals, • Notifications and reminders, • Create visual dashboards using:, • SharePoint views, • Power BI (preferred) or Excel integrations, • Improve data quality and efficiency by:, • Reducing manual tracking and reporting, • Automating repetitive governance tasks, • Ensure dashboards are execfriendly and aligned to KPIs used by leadership 1. FinOps & Financial Governance Support • Assist FinOps leads with:, • Cloud cost analysis (AWS/Azure), • Spend trend analysis (actuals vs forecast), • Cost allocation, showback, and chargeback data validation, • Help maintain optimization & savings trackers:, • Savings initiatives, • Forecast accuracy, • Cloud commitment utilization (e.g., Savings Plans / RIs), • Support preparation of financial insights for IT and business stakeholders, • Collaborate with engineering and finance to understand cost drivers behind technical decisions 1. Data, Tools & Automation • Work with structured and unstructured data from:, • Cloud dashboards (e.g., Cost Explorer, CUDOS-type reports), • Excel, Power BI, or similar analytics tools, • Help automate:, • Status reports, • Cost summaries, • Repetitive tracking mechanisms where feasible, • Apply analytical thinking to connect technical activity to financial impact, • Currently enrolled in a bachelor's or graduate degree program at an accredited academic institution in a relevant field (Business, Management, Finance, Economics, Information Systems, Computer Science, Engineering, or related discipline), • Working knowledge or hands on experience with SharePoint and creating or supporting workflows and dashboards., • Solid analytical and organizational skills., • Exposure to AWS, FinOps concepts, cloud billing or cost optimization, • Agile/Scrum/PMO methodologies, • Proficiency in Excel, Power BI exposure preferred., • Eligible to work in the United States, • Must be a rising junior or senior, • Ability to work onsite at our Nutley, NJ office three days per week (Tuesday-Thursday), • Local candidates preferred due to the onsite requirement Eisai Salary Transparency Language: The hourly rate for the IT Intern, Global Infrastructure Office is : $25. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: _ _

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. We are seeking a Director of Commercial Data Management to build and lead a high-performing function that ensures our data is trusted, well-governed, and analytics-ready. You will own enterprise master data, data quality, and service operations, partnering closely with Business, Analytics, and IT to enable priority use cases (e.g., incentive compensation, field reporting, forecasting, omnichannel). This is a hands-on leadership role for a data leader with strong subject-matter expertise and deep domain/data knowledge who can translate business requirements into scalable solutions and measurable outcomes. Key Responsibilities • Own and operate enterprise Master Data Management (MDM) across HCP/HCO and Payer domains, including match/merge survivorship, hierarchies, lineage, and stewardship workflows., • Define and enforce data standards, metadata, and a single source of truth across Bronze/Silver/Gold layers; ensure domain-based models and analytics-ready outputs., • Establish a unified Data Quality Management (DQM) capability: centralized rule catalog, monitoring, alerting, SLAs, and root-cause remediation., • Lead the management and continuous improvement of the enterprise data catalog, ensuring comprehensive metadata, data lineage, and business glossary coverage; drive adoption and data discoverability across the organization. (Experience with Informatica IDMC preferred.), • Launch and run a business-facing Issue Intake & Triage service with clear ownership, SLAs, and communication; publish operational dashboards and KPIs., • Lead use-case-driven requirements (BRDs) and change control; embed end-user validation gates and definition-of-ready/done across delivery teams., • Deliver Reporting-Ready Data (RRDs), data dictionaries, and a governed KPI catalog for critical business use cases., • Partner with IT Data Infrastructure on medallion architecture, security/compliance, lineage, and performance; drive platform and model reuse., • Manage vendor ecosystem with RACI, SLAs, and QBRs; collaborate with PMO to improve execution quality and reduce total cost of ownership., • Hire, mentor, and develop a multidisciplinary data team (MDM, DQM, stewardship, service management); build internal SMEs to reduce outsourced dependency. Qualifications • Bachelor's/Master's in Information Systems, Data Management, Computer Science, or related field; advanced degree preferred, • 10-15+ years in enterprise data management with hands-on MDM (match/merge, survivorship, lineage) and domain modelling; 5-8+ years working with pharma/commercial data (HCP/HCO, payer, hub/SP, CRM, omnichannel, sales) strongly preferred, • Demonstrated subject-matter expertise and deep domain/data knowledge; track record translating business requirements into scalable data solutions and measurable outcomes, • Experience building unified DQM (rule catalog, monitoring, SLAs) and operating business-facing issue intake portals, • Experience managing and optimizing enterprise data catalogs (Informatica IDMC or equivalent strongly preferred), • Proficiency with Informatica DQ/Catalog, • Vendor management and PMO collaboration in multi-vendor environments; excellent communication, stakeholder management, and change leadership. Preferred Attributes • Experience designing domain-based Silver/Gold models and delivering Reporting-Ready Data (RRDs) and KPI catalogs, • Familiarity with privacy, compliance, and audit needs for healthcare data; experience defining data stewardship SOPs and DCR workflows., • This role is hybrid in Nutley, NJ and requires 3 days onsite per week (Tuesday, Wednesday and Thursday) Eisai Salary Transparency Language: The annual base salary range for the Director, Commercial Data Management is from :$197,100-$258,700 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit _. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: _ _

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Analyzes business and technical processes to formulate and develop new and modified business information processing systems. Develops, maintains, and establishes operational specifications for systems considering such things as information flow, volume, ad hoc reporting, analysis and document format. Represents the business unit to define requirements and business cases for the technology developments. Coordinates with business and technology teams ascertaining system requirements, such as program functions, output requirements, input data acquisition, execution of users acceptance and may coordinate testing, and system techniques and controls. Requires knowledge of computer system capabilities, business processes, and workflow. Essential Functions Systems Technologies Leadership Drive definition of future state solution architecture by establishing strong business relationships, creating a strategic roadmap for realizing the vision, and articulating technology impact to business processes and the overall function. Provide strategic oversight of relevant technologies and platforms. Monitor industry & technical trends and recommend appropriate technologies and platforms to accommodate evolving regulatory requirements, user needs and business and functional requirements. Lead the development, support and rollout of relevant technologies and platforms. Accountable for overall quality and delivery of technology solutions. Application Support and Operations Management Manage the development, deployment, monitoring, maintenance, upgrade, and support of relevant and platforms with business and IT and stakeholders as required. Oversee provision of end-user services, including technical support services. Coordinates and monitors support activity daily. Escalates major incidents within the IT organization and/or cloud provider. Communicates support status on a regular basis. Ensure managed service partners are meeting established SLAs. Oversees SaaS provider system and support performance. Manage IT assets and software components and liaise with infrastructure teams for hardware and equipment asset management, as required. Assist in negotiations and administer vendor, outsourcer, and consultant contracts and service agreements, as required. Requirements Education, Work Experience, and Domain Knowledge College diploma or university degree in the field of computer science, information science, management information systems, or business administration. 5-7 years related work experience in pharmaceutical domain designing, implementing, and supporting Enterprise-grade Revenue Management (Contracting, Gov't Pricing) oriented technical solutions (e.g., Model N Powered N) meeting complex business requirements. Minimum 4 years' experience supporting /administering Model N Power by N SaaS platform. Leadership and Teamwork Demonstrated skills in helping negotiate priorities and resolving conflicts among project and functional stakeholders. Demonstrated ability to influence and drive adoption of new technologies, processes, and solutions. Communication, Organization and Problem-Solving Skills Strong problem-solving and software triage skills with ability to work cross-functionally in a fast-paced and rapidly changing work environment to dissect root cause of issues creating the best solution for Eisai considering quality, cost, and speed requirements Excellent written and verbal communication skills and strong cognitive ability especially with respect to understanding, documenting, and describing complex technical subjects. Excellent interpersonalandcollaborativeskills with astrong customer-centricfocusare necessary. Strong project management with ability toplan,organize, prioritize, and work effectively in aconstantlyfast paced andchangingdynamicenvironment. Eisai Core Values Consistent demonstration and embodiment of Eisai company core values Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity. Information Technology Planning, Analysis, Design, Architecture and Management The ability to work at all levels of the organization to develop a vision for platform roadmaps and maintain consensus around the strategic direction allowing us to meet Eisai business needs. Strong understanding of project management principles and Systems Development Life Cycle standards and familiarity with agile software delivery methodologies such as Scrum. Experience in managing application / system changes in accordance with computer system validation, 21 CFR Part 11 and GxP policies and /or Regulatory Controls (e.g., SOX- Sarbanes-Oxley) Eisai Salary Transparency Language: The annual base salary range for the Manager, Americas Revenue Management Platform IT is from :$123,600-$162,200 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit _. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: _ _

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. JOB SUMMARY: As a member of the Data Analytics group, the Associate Director, Commercial Analytics is part of a high performing team that provides actionable, innovative solutions to address key business questions & opportunities. The position requires a person who can work independently with limited supervision and feel comfortable working across a complex matrix environment including interaction with third party vendors and consultants, Eisai management and current and potential partner companies. Documented expertise in a variety of disciplines is a plus in this position. KEY RESPONSIBILITIES: • This position will be responsible for providing analytics support and recommendations to senior sales, marketing, and market access leadership regarding various initiatives, targeting efforts, analyses and ad-hoc queries., • Proactively identify solutions to field needs with existing report data. Lead the review of recommended solutions with field leadership for confirmation and development of action plans. Build training documents to ensure optimal use of tools., • As "Subject Matter Expert" this position interprets key business reports providing business insights/cause effect pertaining to the reported information., • This position develops and maintains reporting and validation testing standards for the department, and monitors compliance with these standards., • Oversee data quality management process for assigned brand/s with external and internal data providers to ensure timely, accurate and complete patient and specialty pharmacy data., • Per assigned business responsibility, this position interacts with field and home office personnel to understand the business information needs, make recommendations and documents necessary reporting requirements. Additionally, this position acts as the key "go-to person" for resolving field reporting and data inquiries issues., • This position works closely with Field Sales through regular feedback meetings and surveys to continually improve systems and processes aimed at increasing Field effectiveness and company performance., • Develop & maintains business rules/ SOP documentation with internal stake- Lead Third Party Agreements and Vendor Management for assigned business group REQUIREMENTS: • Bachelor's Degree (BS/BA) in an analytic discipline - engineering, mathematics, statistics, economics, etc. Master's degree in a similar field or an MBA preferred, • Summarize, analyze, prepare, present various reports and findings in a clear/concise manner, • Strong Knowledge of third party pharmaceutical sales and script data (DDD, NSP, Xponent, DataView, longitudinal patient data, claims data, etc.), • A minimum of 10 years' experience in the pharmaceutical industry specific to commercial operations or related field is required, • Deals with concepts and complexity comfortably, • Excellent administrative, organizational, project management and analytical skills are required, • Customer focused with excellent communication skills and ability to work with all levels within organization, • Experience in working with IT staff as well as familiarity with Veeva and storage/organization, data access for organizational consumption, • MS Excel, PowerPoint and BI tools (MicroStrategy, Tableau, etc.) -Intermediate to Advanced user, • Prior consulting experience a plus, • Finely tuned attention to detail, • Excellent organizational skills and the ability to balance multiple demands, • Excellent communication, presentation and interpersonal skills, • Proven and successful team player, • This role is hybrid and requires working in our Nutley, NJ office 3 days per week (Tuesday, Wednesday and Thursday) Skills:Advanced Data Analytics, Business Acumen, Communication & Cross-functional Influence, Critical Thinking & Business Agility, Data Governance Expertise, Market Research Skills, Mentoring/ People Development Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Commercial Analytics is from :$174,900-$229,500 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit _. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: _ _

Job DescriptionField SuperintendentAbout the Company Our client is a well-established, growth-oriented commercial flooring contractor with a strong reputation for execution, professionalism, and long-term customer relationships. They partner with general contractors, developers, and end users on high-profile projects and are known for delivering quality work while maintaining a highly collaborative, team-driven culture. This is an organization that values accountability, attention to detail, and people who take pride in owning their projects from start to finish. Core Objective Serve as the professional face of the company in the field. Execute projects safely, strictly to manufacturer specifications, on schedule, and within budget to protect gross profit and exceed customer expectations. You own the physical jobsite and labor execution. Pre-Construction & Planning • Sales Support: Collaborate with Sales during the pricing phase to provide accurate labor estimates, identify logistical challenges, and recommend means and methods that improve profitability., • Site Validation: Conduct pre-job site walks to assess subfloor conditions and verify that material quantities align with actual field conditions., • Labor Buy-Out: Secure and manage qualified in-house and subcontract labor based on established project budgets.Field Execution & Professionalism, • Jobsite Excellence: Maintain a clean, organized, OSHA-compliant, and highly professional jobsite. Coordinate effectively with customers, general contractors, and other trades., • Quality Control: Monitor site conditions and installation methods to ensure all work aligns strictly with manufacturer specifications., • Material Management: Coordinate deliveries and oversee receipt, storage, and tracking of all materials to prevent loss, damage, or theft.Financial Oversight & Closeout, • Scope Protection: Identify out-of-scope work in real time. Do not proceed with additional work without proper approval and executed change orders., • Invoice Management: Review and approve subcontractor invoices based on verified progress and adherence to budget., • Project Closeout: Drive punch list completion, ensure proper documentation, and deliver attic stock to the customer, leaving a strong final impression.What They’re Looking For, • Strong field leadership with the ability to manage multiple projects and crews, • High attention to detail and commitment to quality execution, • Ability to communicate effectively with customers and internal teams, • Comfortable taking ownership and operating with minimal oversight, • Experience with commercial flooring installation and jobsite management

Crane Aerospace and Electronics has an exciting opportunity for a Sr. Manufacturing Engineer Managerat our West Caldwell, NJlocation. About Crane: Crane Aerospace & Electronics supplies critical systems and components to the aerospace and defense markets. You'll find Crane Aerospace & Electronics in some of the toughest environments: from engines to landing gear; from satellites to medical implants and from missiles to unmanned aerial systems (UAS). Every time you use phone navigation, make a bank transaction or have food delivered to your home, Crane Aerospace & Electronics Microwave product is hard at work. Located in the tight-knit, family-first West Caldwell, NJ., community, our West Caldwell facility supplies industry-leading microwave components and systems for use in space, defense and commercial applications, including GPS III satellites. With more than 60 years of expertise, our Microwave group has proven capabilities in major military, communications, electronic warfare, radar and satellite systems. Start the next chapter of your career with Crane Aerospace & Electronics! Job Summary: The Senior Manufacturing Engineer Manager leads the Manufacturing Engineering team, overseeing machining and special process development, CNC and CMM programming, tool and fixture design, and process validation. This role supports Value Stream leadership in productivity improvement, lead time reduction, and New Product Development (NPD) activities, ensuring all customer and internal cost requirements are met or exceeded. Key Responsibilities: • Oversee development and optimization of manufacturing processes including assembly, testing, tooling, fabrication, and SPC while ensuring compliance with company policies, customer requirements, and AS9100 standards., • Drive continuous improvement through setup reduction, visual standard work, cost-reduction initiatives, Value Stream Mapping, and Kaizen activities aligned with Crane Business Systems (CBS)., • Evaluate and approve engineering requests, determining feasibility, make/buy status, and workload priorities; collaborate cross-functionally to ensure cost-effective manufacturing for new and revised products., • Prepare and manage departmental budgets; oversee justification, selection, and acquisition of capital equipment to support operational efficiency., • Support New Product Introduction (NPI) activities through participation in IPTs and ensure successful internal manufacturing readiness., • Provide leadership and guidance to assigned personnel, ensuring adherence to company policies, work rules, and applicable Bargaining Unit Agreements. Minimum Qualifications: Experience: 8+ years of relevant experience demonstrating expertise in manufacturing engineering and process development. Knowledge: Strong understanding of continuous improvement tools, raw materials, production processes, quality control, and cost optimization techniques. Skills: Critical thinking, time management, decision-making, and excellent communication skills; ability to motivate and develop teams effectively. Education: Bachelor's degree in electrical, Electro-mechanical, Industrial, or Mechanical Eligibility Requirement: This position may require access to Controlled Data or Information. Where the position requires such access only US Persons will be considered. As a US Department of Defense contractor, we are bound by International Traffic in Arms Regulations (ITAR). Preferred Qualifications: • Advanced degree (MBA or MS) preferred. Working Conditions: • Working conditions are normal for a manufacturing environment, • Manufacturing operations may require the use of safety equipment to include but not limited to: eye safety glasses, gowning, masks, hearing protectors, heel/wrist straps and any other required PPE, • May be exposed to unusual environmental conditions such as loud noises, cold temperatures, confined spaces, dust or fumes, • Schedule will fluctuate depending on the needs of the business Standing: up to 100% *percentage is approximate and may vary depending on work task Sitting: up to 100% *percentage is approximate and may vary depending on work task Lifting (in pounds): up to 25 pounds Pushing (in pounds): up to 25 pounds Mental/Visual: use of computer Workspace (line, cube, etc):work bench Top Benefits: As a team member at Crane Aerospace and Electronics, you'll enjoy: Benefits: Health care, dental, vision, life and disability insurance starting the first day of the month Time Off: 15 days of paid time off that start accruing your first day at Crane and 12 paid holidays per year. 401k Retirement Plan: 401k plan with company match Education Reimbursement: eligible after 6 months of employment You can see a list of our benefits at https://www.craneae.com/company/careers or visit our website at www.CraneAE.com for more information on our company and great opportunities. We are committed to operational excellence and world class processes. We employ Lean manufacturing techniques to optimize manufacturing efficiency and accuracy on all product lines. Our products are known for their technical strength, proven reliability and overall value. In our efforts to maintain a safe and drug-free workplace, Crane Aerospace & Electronics requires that candidates complete a satisfactory background check. FAA sensitive positions require employees to participate in a random drug test pool. Salary range: $185,500.00 to $220,000.00. Several factors contribute to actual salary, including experience in a similar role or performing comparable job responsibilities, skills, training, and other qualifications. Some roles may be eligible for participation in performance-based bonus programs. This description has been designed to indicate the general nature and level of work being performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Crane Company. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, gender, sexual orientation, general identity, national origin, disability or veteran status.

We’re hiring a Senior Electrical Engineer to play a key role in the full product development lifecycle of commercial-grade equipment, from concept and design through validation, production, and continuous improvement. You’ll partner closely with engineering, sourcing, marketing, sales, a

Salary: $100,000 - $110,000 per year A bit about us: My client is a leading medical device manufacturing company and is growing! They are looking to add a Validation Engineer who will be responsible for Validation/PPAP Packages on new customer programs, as well as ensuring compliance is applicable r

Key Responsibilities** - Review and author payments risk and control assessments across payment capture and validation, authorization, tracking, funds control, smart routing, FX conversion, netting, prioritization, returns, and tokenization - Evaluate inherent risk, residual risk, and control effect

We’re hiring a Senior Electrical Engineer to play a key role in the full product development lifecycle of commercial-grade equipment, from concept and design through validation, production, and continuous improvement. Create and maintain CAD models, schematics, and technical documentation usin

This position directs and oversees the care provided by other caregivers through delegation, validation, evaluation, and coordination. At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and colla

Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change. The Registered Nurse functions as a caregiver for a specific patient population in order to achieve desired outcomes. This position focuses on expanding knowledge and skills, provides effective direct care as part of the interdisciplinary team to a variety of complex patients. This position directs and oversees the care provided by other caregivers through delegation, validation, evaluation, and coordination. This position effectively coordinates patient care/unit activities among nursing peers, physicians and support services. A minimum of an associate in Nursing or diploma of Nursing degree. BSN in progress and/or willing to acquire within three (3) years of hire. Must have a current and valid Registered Nurse license to work at the assigned HMH location by date of hire.BLS/CPR certification by American Heart Association is required within 60 days of hire. Must have six (6) or more months of relevant nursing experience OR must be an active participant with Hackensack Meridian Health's Nurse Residency Program. The ability to learn quickly and adapt to changing patient needs, a strong sense of accountability for improving the lives of our patients and their caregivers, an exceptional focus on teamwork, dedication to ongoing education and the ability and passion to deliver the highest quality of care based on a strong sense of patient focus are all required. National Certification in area of specialty preferred when eligible. 177786 Minimum rate of $48.18 Hourly HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to: Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. Experience: Years of relevant work experience. Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training. Skills: Demonstrated proficiency in relevant skills and competencies. Geographic Location: Cost of living and market rates for the specific location. Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization. Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts. In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits. HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.

Optum NY, is seeking a Medical Assistant to join our team in Rutherford, NJ. Optum is a clinician-led care organization that is changing the way clinicians work and live. As a member of the Optum Care Delivery team, you'll be an integral part of our vision to make healthcare better for everyone. At Optum, you'll have the clinical resources, data and support of a global organization behind you so you can help your patients live healthier lives. Experience the fulfillment of advancing the health of your community with the excitement of contributing new practice ideas and initiatives that could help improve care for millions of patients across the country. Because together, we have the power to make health care better for everyone. Join us and discover how rewarding medicine can be while Caring. Connecting. Growing together. The role of the Medical Assistant is to provide care to patients/significant others via direct and/or telephone contact, following established standards and practices. S/he coordinates with other members of the care team to ensure seamless care delivery, maximal coordination of efforts, and active patient participation in planning and care. Assists physician or other provider with clinical procedures. Hours of Operation: Mon-Fri 7a-8p, Sat-Sun 8a-8p (extended hours - 13 hours daily, 7 days per week 365 days) Primary Responsibilities: • Demonstrates clinical competence in the direct care of patients in established area(s) of practice, and assisting MDs with procedures, • Performs clinical duties within scope of practice complying with the accepted CareMount Medical and/or individual department standards, policies, and protocols, • Demonstrates a proactive approach to patient care, focusing on addressing each patient's individual and family needs at the time of service; communicates identified needs in a timely manner, • Directs and/or escorts patients to exam rooms in a timely manner, • Demonstrated clinical competence when assisting physician/mid-level healthcare professional and/or nurse during exams and office diagnostic procedures/treatments, • Performs authorized procedures competently (i.e. vital signs, vision screening, selected laboratory tests) as directed by physician or nurse in clinical practice area, • Seeks validation/guidance from physicians, mid-level healthcare professional and/or nurse when necessary, • Prepares e-prescriptions for processing to pharmacies when instructed to do so by physician per CareMount Medical policy, • Inspects, cleans/prepares and processes instruments/equipment according to manufacturers' or CareMount Medical guidelines, • Processes specimens for transport to laboratory, ensuring that specimens are properly labeled and appropriate orders have been placed in NextGen You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in. Required Qualifications: • Current Nationally Recognized Medical Assistant Certification, • 2+ years of clinical experience in a medical office, clinic or hospital setting Preferred Qualifications: • Graduate of an accredited medical assistant program with 1+ years of recent experience as a medical assistant, • Current CPR / BLS certification Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). The hourly pay for this role will range from $16.15 to $28.80 per hour based on full-time employment. We comply with all minimum wage laws as applicable. At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. UnitedHealth Group is an Equal Employment Opportunity employer and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status. UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.

Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change. The Registered Nurse functions as a caregiver for a specific patient population in order to achieve desired outcomes. This position focuses on expanding knowledge and skills, provides effective direct care as part of the interdisciplinary team to a variety of complex patients. This position directs and oversees the care provided by other caregivers through delegation, validation, evaluation, and coordination. This position effectively coordinates patient care/unit activities among nursing peers, physicians and support services. A minimum of an associate in Nursing or diploma of Nursing degree. BSN in progress and/or willing to acquire within three (3) years of hire. Must have a current and valid Registered Nurse license to work at the assigned HMH location by date of hire.BLS/CPR certification by American Heart Association is required within 60 days of hire. Must have six (6) or more months of relevant nursing experience OR must be an active participant with Hackensack Meridian Health's Nurse Residency Program. The ability to learn quickly and adapt to changing patient needs, a strong sense of accountability for improving the lives of our patients and their caregivers, an exceptional focus on teamwork, dedication to ongoing education and the ability and passion to deliver the highest quality of care based on a strong sense of patient focus are all required. National Certification in area of specialty preferred when eligible. 180937 Minimum rate of $47.64 Hourly HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to: Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. Experience: Years of relevant work experience. Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training. Skills: Demonstrated proficiency in relevant skills and competencies. Geographic Location: Cost of living and market rates for the specific location. Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization. Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts. In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits. HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.

Job DescriptionJOB DESCRIPTION:The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. RESPONSIBILITIES:Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc. Review CRF, database design, and edit check specs Review study quality surveillance plan and monitor study conduct Prepare and/or review SAP, TFL shells and specifications for variable derivation Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables Provide statistical and validation support for statistical analysis, analysis datasets and TFL Review study report, manuscripts and other documents related to statistics Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents Perform other ad-hoc statistical activities as needed Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming Participates in monitoring CRO activities and reviewing CRO deliverables Other duties as assigned QUALIFICATIONS:Education: Ph.D. or MS in Statistics or Biostatistics Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience Excellent knowledge of SAS computer package Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines Excellent organizational skills, time management, and ability to meet established deadlines. Excellent communication and interpersonal skills to effectively interface with others Exceptional interpersonal skills and problem-solving capabilities Ability to work independently and collaboratively Ability to provide leadership for the CRO statisticians and statistical programmers PHYSICAL AND MENTAL REQUIREMENTS:Ability to multitask Adapts to change Maintain composure under pressure Ability to follow verbal or written instructions and use of effective verbal communications Adapts change, adjust change and grasps information quickly Examine and observe details

Job DescriptionQuality Control Microbiology SupervisorAllendale, NJ The Quality Control Microbiology Supervisor organizes, and directs staff to meet and exceed cGMP requirements, establish KPI’s, while adhering to quality control-microbiological and technical standards. Provides oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Team Leadership - Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervised the following roles: QC Microbiology Associates, • Investigate and document non-confirming events and environmental excursions., • Troubleshoot and recommend process improvements to achieve greater efficiency ad meet quality goals., • Interact with other Microbiology departments on a regularly scheduled basis to discuss and harmonize best practices, procedures and processes between the sites., • Participate in department and cross functional meetings., • Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Author and revise Standard Operating Procedures, Work Instructions, forms and Protocols to reflect current practices., • Perform microbiological and environmental monitoring data review. Compile and issue quarterly and annual Environmental Monitoring trending reports., • Provide staff development through feedback aimed towards performance development and review., • Ability to remain focused and effective in high stress situations., • Builds constructive working relationships characterized by a high level of acceptance, cooperation, and mutual respect., • Able to handle challenging interpersonal relationships., • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Aseptic Processing StandardsREQUIREMENTS, • BS in Microbiology or relevant field required., • Biotechnology Certificate and/or cGMP experience, • Minimum of 3 years of experience with environmental monitoring or within the biopharmaceutical industry., • Strong knowledge of microbiological test methods, philosophies, method validation and method transfer., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office, Excel, and MODA., • Must have ability to work in a team-oriented environment and with vendors., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The employee must be able to comply with personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role., • An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects., • Must be physically capable to stand, walk, sit, bend, stretch, use hands to handle or feel, reach with hands and arms, and talk or hear., • The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance), • Heavy cryo-gloves must be used when working with liquid nitrogen, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately 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 DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for 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., • Track and trend relevant quality metrics including environmental monitoring data., • 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., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • Computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. 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 Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. Japan. Job Summary: Responsible for the management and execution of various aspects of translational and early-stage clinical studies (implementation, site selection, patient recruitment, vendor selection and oversight, tracking clinical data, etc.) for global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. This is a hybrid position that requires to be in the Paramus office twice a week. Essential Duties and Responsibilities: • Develop and deliver program level translational and early-stage clinical drug development strategy, • Design, plan and execute biomarker strategies to inform indication priorities, commercial differentiation, regulatory strategies, biomarker qualification plan, and that achieve biomarker-driven milestones, such as target engagement, measurement assay development and validation, pharmacodynamic activity, and other biomarker contexts of use in clinical-stage programs, • Integrate with colleagues in discovery research and research-stage project teams to identify translational biomarkers and demonstrate preclinical target engagement, methodology of detection and measurement, proof-of-mechanism, pharmacodynamic activity, PK/PD relationships., • Plan, implement, manage and report for regional or global clinical studies., • Manage and Lead selection process of CROs for regional or global clinical studies., • Direct, oversight and manage the performance of study vendors (e.g. CROs and central labs)., • Provide direction and guidance with the Clinical Lead to achieve project objectives., • Manage and resolve project performance issues (issue management) if they arise., • Manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans., • Responsible for the creation of study related documentation (protocol, ICF, CRF, operations manuals etc.)., • Tracking clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans., • Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols., • Manage negotiation of clinical trial contracts between investigational sites and CROs., • Oversight of data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan., • Responsible for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites., • Implement project specific training program and training materials, • Create and maintain clinical SOPs and TMF as part of global QMS and TMF processes., • As needed and required perform other tasks and functions. Supervisory Responsibility: • Provide advice, professional development, and conduct performance management with cross-functional groups if applicable. Qualifications: • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, NS Pharma Japan (HQ), external partners and vendors., • Experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets., • Good cross-functional team leader who fosters team spirit and team motivation (teamwork), • Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies., • Ability to anticipate and timely escalate issues and to define appropriate action plans, • Decision-making and problem-solving skills, • Ability to handle multiple tasks and prioritize, • Strong organizational, communication and presentation skills, • Team player, flexible, ability to adapt to change Education and/or Experience: • PhD and/or MD with 8+ years of experience in pharmaceutical or biotech R&D. MS or BS with 12+ years of R&D experience with progressive levels of team leadership also considered., • Preference for those with 5+ years’ experience as a Translational lead for clinical programs. Experience with Ph2/3 or registrational programs desired., • Excellent understanding of drug development, regulatory processes and clinical development, • Must have rare disease experience, • Strong leadership abilities and proven abilities to lead a team within a matrix organization as well as able to work independently and be proactive. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $175,000 to $220, 000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training, • Flexible Work Arrangement Programs Applications will be accepted until July 1, 2026 or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Job DescriptionQuality Control Analytical ScientistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a Senior Member of the team the QC Analytical Scientist will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle. • Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients., • Support routine GMP testing as assigned. Mentor and train team members, • Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements., • Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports., • Create validation project plan i.e., timelines and resources and provides status updates to management. Utilize statistical tools for evaluation of method validation and trending data., • Identify, evaluate, and implement continuous business process improvements., • Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS)., • Provide support during laboratory investigations., • Train QC personnel during method transfer and validation. Provide support during equipment qualification., • Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices., • Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures., • Indirectly may supervise cross functional teams including product development, QA, PMP, and Manufacturing.REQUIREMENT, • B.S Analytical Chemistry or other scientific field or MS/Ph.D. in Analytical Chemistry or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products., • 8-10 years of experience in the areas of method development, validation, and transfer., • Direct GMP Experience., • Proficiency in project management skills and tools., • Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc., • Extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs., • Strong Quality orientation with attention to detail required. Analytical and problem-solving skills required., • Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution., • Excellent presentation skills. Ability to communicate to upper management, across departments and within the immediate QC team., • Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction., • Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external., • Must be familiar with GMP lab environment and Aseptic techniques.Working EnvironmentMust have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays, or overtime and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facilityMay work with hazardous materials and chemicals 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 Description Expect Success at Bridgeway! We make a difference in people’s lives by supporting their life goals - our employees and the people we serve alike. We invest in our employees through competitive compensation and benefits, best practice training, and fostering a team-oriented culture that promotes career development. We nurture an environment that values diversity, where inclusivity, equity, and belonging thrive. At Bridgeway, Everyone Learns and Grows together. We give you our best, so you can unleash your full potential. Make a Future at Bridgeway! Who we are: Bridgeway values and promotes quality clinical and administrative practices to foster the best outcomes for persons who come to us for behavioral healthcare. We offer a work environment that supports teamwork, creativity, innovation, professional growth and dedication to the work. At Bridgeway, we never stop growing and innovating our vision of behavioral healthcare for the future. Why you should apply: As a Wellness Specialist-Peer Professional, you will join an evidence-based program and a dynamic team for the opportunity to learn and refine your clinical and engagement skills and accomplish your dream of helping people to make progress on their unique recovery journeys. The work is sometimes challenging and always rewarding by engaging with persons we serve and co-workers as we all learn, grow, and thrive. Department: PACT TEAM 9 Salary: $44,000 - $51,000 annually 5,000 Sign-on Bonus Location: Elmwood Park, NJ Work hours: Monday-Friday 8:00am - 4:30pm Position Overview: As part of a multi-disciplinary, core services team, provides wellness assessment and direct services to people who have serious mental illness and who are enrolled in the PACT Program. Participates: • As a team member in the frequent monitoring and assessment of the mental health status of persons receiving services as well as related variables, including significant others, the home and the community in which the person served lives, • With the team, in the development of psychosocial and comprehensive assessments and individualized recovery plans. Ensures documentation is done on time and with quality to ensure adherence to all DMHAS/Medicaid standards., • In clinical and non-clinical team meetings, including individual and team supervision. Actively seeks out monthly supervision from supervisor. Provides: • Teaching of skills to support each persons’ individualized recovery journey and community integration, • Peer perspective to the team during meetings/interactions, • Clinically-appropriate disclosure of personal life experience to enhance engagement/validation with individuals, • Direct assistance to secure safe, clean, affordable housing, food and clothing, medical and dental services, and appropriate financial support., • Observation and informs team of service recipients stated concerns, mental illness symptoms, and behavior in response to medication and monitors for medication side-effects during the provision of observed self-administration and during ongoing face-to-face contacts, • Coordination of services with other community mental health and non-mental health providers, as well as other medical professionals, • Linkage to entitlement benefits such as Medicaid/NJFamilyCare, social security, rental assistance, and other public assistance (social services, transportation, legal advocacy and representation), • Training and instruction to individuals at home and in the community, including individual support, problem solving, skill development, modeling and supervision to perform personal hygiene tasks, perform household chores, develop and improve money management skills, use community transportation, and locate, finance and maintain safe, clean, affordable housing, • Symptom assessment and management, medication monitoring, medication education and monitoring of side effects for both individuals and families/significant others with service recipients consent., • Wellness services including education and cognitive/behavioral interventions on nutrition, diet, exercise, stress reduction strategies and other wellness tools, • Rapid and flexible response to crisis, including but not limited to: accompanying the individual to the screening center/psychiatric emergency center and remaining with the person during the assessment process, • Use of Illness Management and Recovery (IMR) and development of WRAP and Psychiatric Advance Directives which includes stage wise treatment utilizing Motivational Interviewing, Cognitive Behavioral Interventions and Teaching Strategies, 24-hour rotating on-call coverage with the ability to respond immediately to individuals by phone or in person, • Utilizes evidenced based practices as assigned which may include motivational interviewing, IDDT, CBT skills, IMR, Trauma Informed Care, Permanent Supportive Housing and Career Development when engaging individuals with their recovery, • Technical assistance and education to members of the team in the area of recovery and wellness. Works with the team to develop materials and strategies for teaching wellness strategies including Wellness Recovery Action Plans, instilling hope, promoting choice and empowerment, and spirituality, in conjunction with the team, • Support to assist persons served to find and maintain employment and/or education/training, • Support to the service recipient’s family and other members of his/her social network to help them manage the symptoms and related consequences of the service recipient’s illness, reduce the level of family and social stress associated with the illness, and achieve wellness. Will provide education to assist the service recipient and family to relate in a positive and supportive manner Requirements: Education/Experience: • Bachelor’s degree preferred. A person who is receiving or has received mental health services may substitute demonstrated volunteer or paid experience working with individuals with serious and persistent mental illness in lieu of a Bachelor’s degree., • Two or more individuals may share the Wellness Specialist-Peer Professional position. Driver’s License, Vehicle: • Valid driver’s license required, • No more than one moving violation within the past 12 months, • Vehicle required EXCELLENT BENEFITS: • Benefits: Medical, Dental, Vision, 403b, basic life and AD&D, flexible spending accounts, EAP, • Eligible for medical benefits after 30 days of employment, • Flexible work schedules, clinical training series, leadership development program, • 10 paid holidays (an 11th after 2 years of employment), generous vacation and sick time Bridgeway Behavioral Health Services was founded on a strong desire to fight disparity and injustice alongside people living with behavioral health conditions. We are dedicated to providing a multicultural workplace where everyone feels a sense of purpose and belonging. We provide equal opportunity for employees and applicants in all aspects of the employment relationship, without regard to race, color, national origin, sex, sexual orientation, gender, marital status, military or veteran status, disability, age, religion, or any other classification protected by law. #HP

Job Description Our client in Fairfield, NJ is looking for a Validation Engineer for a Full time position. Pay is $80k-$95k annually DOE • Responsible for Validation/PPAP Packages on new customer programs, as well as ensuring compliance is applicable regulatory bodies and standards (ISO13485, 21 CFR 820, GMP). Requirements: • Requires a 4-yr engineering degree or substitute experience; a graduate degree in engineering, technical, or management discipline is preferred., • Minimum of 5 yrs. (equivalent) experience in product quality position, with direct experience PPAP/Validation Deliverables., • Experience in the medical device/ (GxP) industry is required., • Validation (IQ, OQ, PQ) or PPAP (Production Part Approval Process) required, • Must have knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance Benefits: The company offers a competitive benefits package that includes medical, dental, vision, 401k, pet insurance, etc... Company DescriptionPrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company.PrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company.

Job DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • 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 team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-O-Vator available for use., • Small breakroom available. No on-site cafeteria available.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 DescriptionJob Title: Manufacturing / Integration Engineer II Job Description The Manufacturing / Integration Engineer II supports the engineering and development activities of new and existing products, with a strong focus on manufacturing processes, process validation, and design for manufacturability. This role works across the full product lifecycle, from initial concept and prototyping through scale-up, validation, and transfer to full manufacturing, while collaborating closely with cross-functional teams and external customers. Responsibilities • Support new product launches from initial concept through completion, including prototyping, testing, and transfer of processes to manufacturing., • Develop and maintain detailed project timelines for new product introductions and ensure project tasks are completed through launch., • Create and execute Master Validation Plans and Validation Protocols/Batch Records for new and existing products., • Independently troubleshoot and resolve technical issues encountered during prototyping, scale-up, and manufacturing activities., • Prepare Bills of Materials for new product lines and processes, collaborating with production, quality control, and ERP teams to develop cost of goods estimates., • Write, revise, and maintain batch records and standard operating procedures to support new product introductions and process changes., • Work closely with cross-functional teams such as R&D, Quality, Manufacturing, and Regulatory to make data-driven decisions that align projects with business goals., • Drive scale-up and process optimization initiatives for existing products to improve performance, robustness, and efficiency., • Ensure business continuity by providing prompt investigation and resolution of process performance drifts and supporting CAPA activities., • Apply structured problem-solving methods, including root cause investigations, to address process and product issues., • Support and, when appropriate, lead various special projects and ad hoc assignments related to process development, validation, and improvement., • Engage with customers in a professional and collaborative manner to understand requirements, communicate technical information, and support successful product integration.Essential Skills, • B.S. degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or Biomedical Engineering., • 3–5 years of experience in an engineering role, preferably in development, manufacturing engineering, or process engineering., • Hands-on experience with process validation, including developing and executing validation protocols and batch records., • Experience in process development and process optimization, with the ability to translate pilot or lab-scale processes into robust, manufacturable processes., • Fundamental understanding of manufacturing processes and manufacturing process improvement., • Strong communication skills, including the ability to clearly convey technical information verbally, in writing, and in person to stakeholders at various levels., • Demonstrated ability to execute project deliverables according to schedule and manage multiple tasks in a dynamic environment., • Proven ability to work effectively within a team environment and build productive relationships with cross-functional partners such as R&D, Quality, Manufacturing, and Regulatory., • Experience with structured problem-solving, including issue resolution, root cause investigations, and CAPA activities., • Proficiency in Microsoft Word, Excel, and PowerPoint., • Customer-facing communication skills and professionalism suitable for representing engineering and manufacturing capabilities to external stakeholders.Additional Skills & Qualifications, • Experience in the medical device or similar regulated manufacturing environment., • Background in development, manufacturing engineering, process improvement, and process engineering., • Familiarity with process engineering tools and methodologies for scale-up and process optimization., • Experience with Minitab or other statistical analysis software., • Experience with SolidWorks or similar CAD tools., • Experience with Microsoft Project or other project management software., • Ability to make data-driven decisions and present findings and recommendations to cross-functional teams., • High degree of professionalism, maturity, and ownership over assigned projects and responsibilities., • Comfort working in a fast-paced environment with a constant level of activity and diverse project work.Work Environment You will work on-site as part of a growing engineering team of approximately 9–10 engineers, collaborating closely with an Associate Integration Engineer while also working independently on assigned projects. The role follows a standard daytime schedule of approximately 8:30 a.m. to 5:00 p.m. You may need to travel to New York City 1–2 times per week during the first two months to support integration and collaboration activities. The environment offers a steady flow of diverse projects, opportunities to lead initiatives, and the chance to grow your responsibilities as the engineering team and capabilities expand. The company provides comprehensive benefits, including medical coverage starting on the first day of employment, a 401(k) plan with employer contributions, and frequent employee activities that support a collaborative and engaging culture. The work setting is professional and engineering-focused, with regular interaction across production, quality control, ERP, R&D, Quality, Manufacturing, and Regulatory functions. Job Type & Location This is a Contract position based out of Allendale, NJ. Pay and Benefits The pay range for this position is $48.08 - $65.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Jun 5, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Job DescriptionSalary: Role and Core Responsibilities 1. Market & Consumer Insight • Conduct indepth market research, studying customer needs, pain points, usage behavior, and buying trends., • Analyze competitors (features, pricing, performance, innovation cycles) to identify gaps and opportunities. 1. Product Strategy & Roadmap • Define a clear product vision, positioning, and longterm strategy for the washing machine lineup., • Build and update the product roadmap based on market trends, sales input, and competitive evolution. 1. Product Definition & Requirements • Translate market insights into Product Requirement Documents (PRDs) with detailed feature definitions, performance expectations, and user experience targets., • Determine product specifications such as capacity, efficiency class, motor type, wash programs, connected features, energy requirements, and regulatory compliance. 1. CrossFunctional Leadership • Work closely with R&D to guide product development from concept, prototype testing, and validation to certification., • Collaborate with manufacturing, supply chain, and quality teams to ensure cost optimization, stable production, and product reliability., • Partner with marketing and sales for gotomarket planning, messaging, and launch readiness. 1. Product Development & Innovation • Lead the end-to-end development process, ensuring timely delivery, cost targets, and product performance KPIs., • Promote innovation in functional areas such as washing performance, smart connectivity, energy efficiency, water usage, noise reduction, and user interface design., • Evaluate new technologies (motors, materials, sensors, algorithms, AIdriven cycles). 1. Launch Management • Develop and execute product launch plans, coordinating marketing assets, training materials, retail strategies, and pricing., • Align with channel partners and sales teams for launch volume, forecasts, and promotional activities. 1. Product Lifecycle Management (PLM) • Monitor the performance of each model: sellout, margin, consumer reviews, failure rates, and return reasons., • Adjust strategy based on performance (phasein/phaseout, midcycle feature upgrades, cost engineering). 1. AfterSales Feedback Loop • Collaborate with aftersales and service teams to understand top failure modes, spare parts issues, and user complaints., • Use data to drive product improvements and reduce warranty cost. 1. Pricing & Business Management • Own the products financial performance: cost targets, margin analysis, pricing strategy, and profitability optimization., • Conduct feasibility studies and manage business cases for new models. 1. Stakeholder Communication • Regularly update management and crossfunctional teams with reports, analysis, dashboards, and risk assessments., • Ensure alignment on strategies, timelines, and decisions. Technical and Functional Skills • Strong understanding of washing machine technologies (motors, detergent systems, wash algorithms, safety, regulations)., • Experience in R&D coordination, testing, and quality validation., • Knowledge of energy efficiency standards and compliance requirements., • Business & Analytical Skills: Market research and competitive analysis, financial modeling and pricing, Road mapping & strategic planning., • Soft Skills: Leadership and crossfunctional influence, clear communication and technical storytelling, problemsolving, negotiation, and prioritization. Preferred Skills • MS Office Suite experience a plus, • Power BI, • Supply Chain Management, • International Business Additional Notes • Work shift Monday to Friday Business hours, • Location Costa del Este, Panam, • Available for traveling across the region

Job Description Title: Sr Electrical Engineer Location: Lodi, NJ (Relocation available) Compensation: $120–150k Benefits: Medical, Dental, Vision, 401k matching, product discounts, annual bonus potential Preferred Skills: Consumer product (CPG) electrical design and testing Overview: We’re hiring a Senior Electrical Engineer to play a key role in the full product development lifecycle of commercial-grade equipment, from concept and design through validation, production, and continuous improvement. This role combines hands-on testing, electromechanical troubleshooting, and cross-functional collaboration. You’ll partner closely with engineering, sourcing, marketing, sales, and production teams to ensure products meet real-world performance, reliability, and durability requirements. Job Duties: • Support electrical and electromechanical design throughout the full product development lifecycle, including concept, prototyping, validation, and production release., • Work with electromechanical components (motors, solenoids, sensors, etc.) across multiple product lines., • Lead product durability, performance testing, failure analysis, and continuous improvement initiatives., • Perform hands-on testing and validation in the Lodi workshop and provide technical guidance to in-house technicians., • Collaborate with overseas manufacturing partners to support design for manufacturability, quality standards, and production efficiency., • Conduct competitive benchmarking and translate findings into actionable design and performance improvements., • Create and maintain CAD models, schematics, and technical documentation using SolidWorks or Pro/Engineer (Creo)., • Provide cross-disciplinary troubleshooting support, including mechanical-focused issues when required., • Occasional travel (2–3 trips/year) for supplier visits, manufacturing support, and team collaboration. Qualifications: • 5–8 years of electrical or electromechanical engineering experience supporting mass-produced products., • Demonstrated experience working through the full product development lifecycle in a commercial or consumer product environment., • Background in rugged, commercial-grade, high-volume products., • Proficiency in SolidWorks or Pro/Engineer (Creo)., • Strong communicator with the ability to collaborate across engineering, manufacturing, and business teams., • Passion for designing and delivering durable, reliable, and high-performing products. Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

Job Description Are you the kind of person who loves taking things apart just to see how they work? Do you thrive on designing, building, and pushing the boundaries of what's possible? If so, we'd love to meet you! We are a collaborative-oriented team dedicated to innovation, excellence, and making a difference. Our desire is not to be the biggest but the best. We are looking to create cutting-edge packaging solutions that impact industries and improve lives. Every day, we challenge ourselves to design better, smarter machines - striving to be the best. Position Summary: We are seeking a skilled and motivated Mechanical Engineer to support the design, development, and improvement of our products and systems. The ideal candidate has a strong foundation in mechanical design, problem-solving skills, and a passion for innovation. Key Responsibilities: • Design, develop, and test mechanical systems and products., • Create detailed 3D models, engineering drawings, and specifications., • Collaborate with cross-functional teams, including manufacturing, quality, and sales., • Research materials and processes to enhance product performance and efficiency., • Analyze project requirements, identify technical challenges, and propose solutions., • Participate in prototyping, testing, and validation of new products., • Support continuous improvement initiatives on existing equipment and designs., • Ensure designs comply with applicable codes, standards, and regulations. Qualifications: • Bachelor’s degree in Mechanical Engineering or related field., • 3+ years of mechanical design experience, including hands-on machine design (required), • Prior experience leading design efforts or supporting junior engineers is a plus, • Proficient in CAD software (Inventor, SolidWorks, AutoCAD, or similar)., • Strong understanding of mechanical systems, materials, and manufacturing processes., • Knowledge of GD&T (Geometric Dimensioning and Tolerancing) principles., • Excellent analytical and problem-solving abilities., • Strong communication skills and ability to work both independently and in a team., • Experience with FEA analysis, PDM systems, or ISO 9001 processes is a plus. Why Join AZCO Corp? • Competitive salary and comprehensive benefits package, • Collaborative, innovative, and supportive team environment, • Opportunities for career growth and professional development, • Work on challenging and rewarding projects that make a real impact.Company DescriptionAZCO Corp has over 40 years of experience developing solutions for a wide range of feeding, cutting, and dispensing applications. It offers cutting-edge, field-proven systems and components.AZCO Corp has over 40 years of experience developing solutions for a wide range of feeding, cutting, and dispensing applications. It offers cutting-edge, field-proven systems and components.

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 looking for a dynamic and experienced Integration and Conversion Engineer with Epic certification and a strong understanding of Epic Historical Data Conversions and Bridges to lead complex healthcare integration projects. In this role, you will manage endto- end delivery of interfaces between Epic and third-party systems via Bridge, ensuring alignment across technical, client, and internal teams. This is a full-time, computer-professional exempt position. The Engineer in this position will be responsible for delivering project(s) that span across multiple software solutions in the ELLKAY product suite to support our growing laboratory and hospital client base. This includes the full project management cycle, including management of issues, risks, and project change requests to ensure successful and on-time project delivery. The Engineer has the authority to run each project on a day-to-day basis and is ultimately responsible for establishing and cultivating a positive working relationship with each laboratory or hospital client from an Operations perspective. Essential Duties & Responsibilities: • Lead and support Epic historical data conversion projects, including planning, execution,and validation, • Migrate interfaces and data from legacy systems to Epic (Bridges, HL7, APIs), • Assist with other non-conversions interface build and testing as required, • Own project delivery for Epic integration initiatives involving the Bridges engine., • Coordinate with Epic-certified analysts, technical teams, client stakeholders, and vendors., • Develop and maintain project plans, timelines, and deliverables across multiple concurrent projects., • Facilitate Kick-off, status, and escalation calls with internal and client teams., • Identify and mitigate project risks while keeping stakeholders informed., • Oversee testing and validation phases (interface functional testing, conversions small/large/full scale testing)., • Ensure projects meet client requirements, Epic standards, and company SLAs., • Maintain documentation, including specifications, mapping sheets, and change logs., • Manage the day-to-day project activities and resources and lead the regular project status update meetings with the customer, • Demonstrate the functional acumen to explain how solutions will address client goals Qualifications: • Epic Bridges Certification ., • 2+ years of project management experience, including tracking and planning projects., • 2+ years of experience with Epic Conversions projects., • Strong knowledge of HL7, Epic Bridges, and EHR/PM interoperability., • Proven experience leading technical or interface teams in client-facing roles., • Excellent communication, organizational, and problem-solving skills., • Ability to manage competing priorities in a fast-paced environment., • Participate in or oversee on-call rotations, supporting critical production incidents and ensuring rapid resolution. Benefits: 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, • Parental Leave Our awesome culture includes: • Working with talented, collaborative, and friendly people who love what they do, • Professional growth within, • Innovation environment, • On site in HQ Free daily lunches Additional information 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 www.ELLKAY.com. 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 DescriptionDescriptionWho We Are: Red Clover, a New Jersey–based HR consulting firm, is hiring on behalf of a client in the logistics and technology solutions industry. This organization is an established, internationally operating provider that supports U.S.-based businesses with global delivery solutions. With a strong focus on innovation, technology, and operational excellence, the company has spent more than two decades helping brands expand their international reach, strengthen their global presence, and scale efficiently. As the organization continues to grow its footprint, it remains committed to investing in advanced delivery and technology solutions to better serve its customers worldwide About the Role: As our Technology Project Manager, you will take ownership of technology-driven projects, ensuring they are executed efficiently, within budget, and on schedule. You will lead the planning and coordination of technical resources, timelines, integrations, and deliverables, working closely with cross-functional teams to meet project goals. Your role involves proactively identifying technical and operational risks and resolving any issues that arise during the project lifecycle, ensuring that quality standards are consistently met. Reporting directly to the Head of Technology, you will maintain clear and consistent communication with all stakeholders, translating technical details into actionable insights, and ensuring alignment across teams. This role requires strong technical acumen, leadership, and the ability to manage competing priorities in a fast-paced environment. About the Candidate: The ideal candidate for the Technology Project Manager role is a highly organized, results-driven professional with a proven track record in managing technical, e-commerce-focused projects from initiation through delivery. They are comfortable working across technical and non-technical teams, managing multiple priorities, and driving execution in fast-paced environments. The individual should be an effective communicator who can translate complex technical concepts for diverse stakeholders and build strong working relationships with internal teams, senior leadership, and external partners. They bring a detail-oriented mindset, strong problem-solving skills, and a commitment to delivering high quality solutions on time. Key Responsibilities • Develop and manage end-to-end technical project plans, timelines, and resources, ensuring smooth execution across systems and teams., • Oversee technical requirements, systems integrations, APIs, and platform dependencies related to e-commerce and fulfillment workflows., • Monitor budgets and allocate resources to meet project goals, deadlines, and technical requirements., • Identify and resolve risks or issues to keep the project on track., • Maintain clear communication with stakeholders and provide regular progress updates., • Ensure that project deliverables meet the required quality standards and are aligned with company expectations., • Work closely with all other departments, including senior management, logistics, customer service and operations, to ensure seamless project execution., • Maintain accurate and up-to-date project documentation, including scope, requirements, and change requests. Document lessons learned and best practices for future projects., • Oversee project closure activities, including final delivery, validation, SOP rollout, and sign-off., • Conduct post-project reviews to evaluate success, capture lessons learned, and identify areas for process and system improvements. Skills, Knowledge and Expertise • Bachelor’s degree or equivalent experience, • 5 years of experience in technical project management, with demonstrated success leading complex, cross-functional initiatives., • Hands-on experience managing projects involving e-commerce platforms, integrations, or digital commerce initiatives required, • Strong experience within logistics, supply chain, fulfillment, or a related industry preferred, • Strong understanding of project management methodologies and best practices; PMP, Agile, or Scrum certification preferred, • Knowledge of PM tools (Monday.com, YouTrack) and familiarity with developer environments (Github, AWS)., • Understanding of technical concepts such as API’s, system integrations, data flows, and platform dependencies, with the ability to communicate effectively with both technical and non-technical stakeholders, • Experience managing project scope, timelines, budgets, and resources, • Strong written and verbal communication skills, • Ability to work collaboratively in a team environment with adaptability and responsiveness Benefits & Core CompetenciesCore Competencies: Communicates Effectively: Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences Customer Focus: Building strong customer relationships and delivering customer-centric solutions Business Insight: Applying knowledge of business goals and the marketplace to advance the organization’s goals

Job Description COMPANY CULTURE Our focus is to deliver world-class solutions to our customers, on time and of the highest quality, as the preferred supplier of highly engineered, energetic, and pyrotechnic devices while developing our associates and maximizing long-term value for our shareholders through organic growth and targeted acquisitions. GENERAL STATEMENT OF DUTIES: The Engineering Manager leads and oversees the engineering department for the design, development, project management, qualification and certification of pyrotechnic and high precision explosive devices, ensuring the development, safety, quality, and compliance of these products and systems. This role involves managing engineering projects, guiding technical teams, and collaborating with quality, manufacturing, safety, and regulatory teams to innovate and deliver reliable, compliant pyrotechnic and high precision explosive devices, solutions for defense, aerospace, and commercial applications. ESSENTIAL DUTIES AND RESPONSIBILITIES: The Engineering will be responsible leading the Engineering team, and executing the strategy aligned with the company's business objectives and growth plans. The Engineering duties and responsibilities are as follows: • Lead and manage a team of engineers specializing in pyrotechnic design, testing, and qualification, • Oversee the development of new pyrotechnic and high precision explosive devices products and systems, ensuring they meet technical specifications, safety standards, and customer requirements., • Oversee the formulation, manufacturing, testing, and validation of explosive and energetic materials, ensuring adherence to strict safety, environmental, and regulatory standards, including compliance with agencies such as the Department of Defense (DoD), DOT, OSHA, and EPA., • Ensure all products and processes comply with relevant industry standards, including MIL-STD, ISO, and safety regulations., • Establish and maintain rigorous safety protocols, handling procedures, and quality assurance processes for sensitive and hazardous energetic materials., • Manage project budgets, schedules, and resources to ensure timely, within-scope, and cost-effective delivery of critical defense and aerospace projects., • Collaborate with government agencies, regulatory bodies, and industry partners to obtain approvals, certifications, and compliance throughout product development and deployment., • Promote a culture of operational excellence, safety, and continuous improvement within the engineering organization., • Coordinate and oversee safety assessments, environmental testing, and certification activities for pyrotechnic devices., • Establish and maintain engineering processes, best practices, and documentation for design, testing, and production., • Manage project timelines, budgets, and resource planning for engineering initiatives., • Collaborate with regulatory, safety, quality, manufacturing, and supply chain teams to ensure compliance and product reliability., • Lead troubleshooting efforts for engineering-related issues, root cause analysis, and continuous improvement initiatives., • Stay current on advancements in pyrotechnic materials, safety standards, and industry regulations. PHYSICAL DEMANDS: Must possess sight/hearing senses or use prosthetics that will enable these senses to function adequately so that the requirements of this position can be fully met. Physical activity includes walking, standing, bending, squatting, reaching above shoulders and lifting up to 40lbs. Must be able to drive an automobile for short and long distances. The candidate for this position will have to spend long hours using a computer, which can cause eye strain. This position will have to manage a number of requests and situations at one time. Stress may be caused by the need to complete tasks within tight deadlines. WORK ENVIRONMENT: Performs office activities in a lighted and ventilated area. May be subject to changes in temperature and exposure to dust. Will be exposed to uncontrolled environmental conditions while driving. Will work in a normally acceptable office environment, with no abnormal hazards or risks. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Travel between two manufacturing sites, Byram NJ and Fairfield. QUALIFICATIONS, KNOWLEDGE, AND SKILLS: • Knowledge of energetic materials, explosives, propellants, and pyrotechnic systems used in aerospace and defense applications., • Strong understanding of aerospace engineering principles, safety protocols, and handling procedures for hazardous materials., • Demonstrated ability to manage large-scale projects, budgets, and cross-functional teams in a high-stakes environment., • Effective decision-making and strategic planning skills., • Strong knowledge of ERP systems, SAP, Sightline, Sage, Epicor., • Strong knowledge of Microsoft applications: Word, excel, power point, share point., • Excellent analytical, organizational, and problem-solving skills, • Excellent leadership, communication, and stakeholder management skills., • Effective leadership and team management abilities., • Project management experience or familiarity with aerospace development lifecycle., • Industry certifications related to aerospace engineering (e.g., ASQ certifications, IPC certifications)., • Strong understanding of testing, validation, manufacturing, and quality control processes for energetic products., • Ability to work effectively in cross-functional teams and meet critical deadlines., • Experience with compliance documentation and certification processes., • Ability to work under pressure and manage multiple tasks simultaneously. EDUCATION AND EXPERIENCE: • Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, Explosive Engineering, or a related discipline; advanced degrees are a plus., • 5+ years of experience in pyrotechnics, explosives, energetics, or related fields, with at least 5 years in a senior leadership role. · Experience in aerospace component development, testing, or systems integration. Strong understanding of aerospace design standards and regulations (e.g., AS9100, FAA, EASA, USG, DOD Requirements). Knowledge of explosive and energetic materials, chemistry, safety protocols, and regulatory standards. Proven ability to lead cross-functional teams and manage complex projects involving hazardous materials. Experience working with regulatory agencies and obtaining certifications or approvals for energetic products. Proficiency in CAD software (CATIA, SolidWorks), simulation tools (ANSYS, MATLAB), and test equipment. Knowledge of materials, manufacturing processes, and environmental testing. Knowledge of air worthiness certification, supplemental type certification, and parts manufacturing authority. DISCLAIMER The above information on this description has been designed to indicate the general nature and level of work performance by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Cartridge Actuated Devices is an Equal Opportunity Employer and encourages the application of female, minority, disabled, and veteran candidates. Due to the potential for exposure to ITAR controlled data, the incumbent in this role must be a US Person (US Citizen or US Permanent Resident). Due to the nature of our products, to the extent applicable to an employee's role, each employee must be able to obtain (and maintain) the ATF Possessor License as a condition of employment.

Job DescriptionTitle: Quality Systems Engineer Reports to: Quality Systems Manager Department: Quality Assurance / Quality Control Supervises: Validation Technician (s) and Quality Associates Organizational Relationships: Contact with all areas of QA/QC, R&D, Purchasing, Operations, Process Engineering, Warehouse, Customers, and other area personnel. Responsibility Summary: The Quality Systems Engineer will perform Process Validation and Cleaning & Sanitization Validation under quality systems to ensure compliance. They will maintain formal drug stability programs, bulk hold studies, product compatibility, SOP binders, supplier and vendor qualification programs, and participate in IQOQ including Risk Assessment of Quality Systems. Responsibilities: The Quality Systems Engineer is responsible for supporting the company's business events through a variety of tasks, including: • Reviews and approves/confirms all new formulas in the Quality Systems., • Design and author protocols and reports to support qualifications, validation and designs of experiments., • Perform capability analysis and trending to support validation and qualifications., • Co-ordinates process validation and product stability programs and maintain associated reports., • Conducts Annual Drug Reviews and Device History Reviews., • Maintains regulatory documents and all documents of external origin., • Maintains Change Control Notices (CC) and effects changes to product specifications for raw materials, bulks, intermediates and finished goods., • Participates in internal and external audit process., • Participates in product recall audits., • Complies with 21 CFR Part 210, 211 & 820.Perform other duties as assigned by the manager., • Perform Process Validation and Cleaning & Sanitization Validation under the quality systems to ensure compliance., • Maintains formal drug stability program, bulk hold studies, and product compatibility by coordinating samples submission, testing, result retrieval and program review., • Maintains files and database of customer-approvals and documents as evidence of authenticity., • Effects changes to specification sheets as approved through proper change control requests., • Initiate Change Control Requests for Customer requested changes to raw material, intermediate/bulk, FGs, specifications., • Maintains copies of approved change controls as applicable to product specification updates/revisions., • Maintains SOP binders and updates such through approved CCs., • Communicates new and updated SOPs to all employees at EWL., • Maintain suppliers and vendors qualification program., • Participate in IQOQ including Risk Assessment of Quality Systems., • Perform annual drug and device history reviews., • Any other special projects and duties at the discretion of the immediate supervisor. Qualifications: • Associate’s degree (2-year college degree) required., • Previous experience in Pharma, Cosmetics, food, medical device, or allied profession preferred., • Good Technical Writing ability., • Excellent knowledge of Word, Excel, Access, and other Windows-based programs., • Good record-keeping skills., • Knowledge of FDA Regulations under FD&C Act is a plus. This position is Full-Time, Onsite in Totowa, New Jersey, five days per week in the office (9:00AM - 6:00PM) Compensation & Benefits: The approximate pay range for this position is $50,000 - $60,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. The benefit package includes: • Medical, Dental, Vision, Life, • PTO, • Special Paid Leave for employees’ personal events, • Company Paid Holidays, • 401(k) employer match, • Year-End Gift Powered by JazzHR w53EO6ptBL

Job Description We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall Responsibilities For Quality Operations And Initiatives, Including • Quality Assurance management:, • Documentation control (master batch record, specification and method), • Batch record review and product disposition, • Investigations, complaints, deviations, CAPAs, APRs, • Production and Pharmaceutical Development support, • APRs, GMP training and SOP review, • Validation / qualification documentation review and approval, • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site, • Develop, maintain, and enhance training programs and systems, • Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives., • Must be able to move about the facility, • Experience with FDA Audit, • Extensive knowledge of US and EU current Good Manufacturing Practices, • Experience with a CDMO would be preferable, • In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for: i). Quality Compliance management: ii). All audits, internal, external - regulatory, client and vendor iii). Vendor management program iv). QA Agreements with clients & contractors v). License renewals Company DescriptionWe are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..

Job DescriptionBenefits: • 401(k), • 401(k) matching, • Dental insurance, • Health insurance, • Paid time off JOB DESCRIPTION Reports to: Director of Engineering and International Sales Manager Location: Cedar Grove, NJ Position Summary: We are seeking a highly motivated Technical Enablement & Solutions Engineer to serve as a strategic technical resource supporting both Engineering and Sales. This role is responsible for evaluating customer applications, supporting pre-sales technical activities, and ensuring opportunities are properly qualified before Engineering engagement. The ideal candidate will combine strong technical knowledge, problem-solving ability, and cross-functional collaboration skills to help improve sales efficiency, technical accuracy, and customer experience. In addition to customer and sales support, this role will actively contribute to engineering initiatives including research and development (R&D), product improvement projects, testing, and validation activities. This position offers an opportunity to directly influence both customer success and product innovation. Essential Functions: Technical Sales & Application Support • Partner with Sales to evaluate customer requirements, specifications, and applications, • Recommend appropriate product solutions based on technical fit and feasibility, • Support complex technical discussions during pre-sales opportunities, • Review opportunities to ensure proper qualification before Engineering involvementEngineering Coordination, • Serve as a technical bridge between Sales and Engineering, • Ensure Engineering resources are focused on qualified, high-value opportunities, • Communicate technical requirements clearly across teamsTechnical Support & Troubleshooting, • Provide advanced technical support to customers, distributors, and internal teams, • Troubleshoot application and product-related issues, • Escalate complex technical challenges as appropriate, • Support distributor technical enablement by identifying recurring knowledge gaps and contributing to the development of application-based training resourcesAdvanced Quoting & Proposal Support, • Assist with technically complex quotations and configurations, • Validate technical accuracy of proposals and product selectionsRMA Analysis & Product Evaluation, • Support investigation of returned products and root cause analysis, • Partner with Quality and Engineering on corrective actions and continuous improvementEngineering Projects & Innovation, • Participate in engineering projects, including but not limited to:, • Research & Development (R&D), • Product enhancements and optimization, • Product testing and validation, • Technical documentation and process improvement initiatives, • Training & Technical Enablement, • Develop technical documentation, product guides, and FAQs, • Support training initiatives for internal teams, customers, and channel partners, • Help create scalable resources that improve efficiency and reduce repetitive inquiriesSystems & Cross-Functional Collaboration, • Maintain technical activity and key insights in HubSpot, • Collaborate closely with Engineering, Sales, Operations, and Customer Care Skills/Qualifications: • Bachelors degree in Engineering or related technical discipline, • 3+ years of experience in applications engineering, technical support, solutions engineering, or similar role, • Strong technical aptitude with ability to evaluate complex applications, • Excellent analytical, troubleshooting, and problem-solving skills, • Ability to communicate technical concepts clearly to technical and non-technical audiences, • Experience working cross-functionally in fast-paced environments, • Experience with CRM systems; HubSpot experience preferred, • Strong organizational skills and ability to manage multiple priorities Performed other duties as directed. Physical Requirements: • Ability to sit, stand, and operate a computer for extended periods of time, • Ability to lift up to 50 pounds, with or without reasonable accommodation

Job DescriptionValidation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device IT & Human Resources disciplines in New Jersey. The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing and QC lab equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. • Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc., • Execute IQ/OQ and /or PQ protocols, • Prepare final reports for executed protocols, • Prepare final reports for vendor IQ, OQ and/or PQ protocols, • Review of executed IQ/OQ/PQ protocols and raw data, • Perform periodic review/requalification of validated equipment, systems and cleanrooms, • Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met, • Assembling validation related documents; and filing/archiving approved documents, • Maintaining electronic records.REQUIREMENTS, • BS/BA in engineering or a related Science discipline, • 3-7 + years of validation experience, • Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc., • Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11., • Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary., • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management., • Must be a dedicated self-starter with a high energy level and able to achieve results., • Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution., • Good time management skills to manage and meet deadlines., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment., • Good computer skills and Microsoft Office knowledge., • Ability to multi-task team is essential., • Flexible and able to adapt to company growth and evolving responsibilities., • Highly organized, detail oriented, and ability to manage multiple priorities., • Ability to perform the job under direct or indirect supervision, • Must have the ability to work in a team-oriented environment and with clients, • Must have the ability to work with specialized equipmentMay occasionally work with pressurized systems. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.Ability to work in cleanroom environment for a moderate amount of time.Ability to lift, transfer, or ship validation equipment or related accessories.While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, or crouch. Must where PPE when appropriate. 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 DescriptionDescription: The Key Objective of the QC Inspector is to contribute to the growth and profitability of Multi-Pak by effectively executing the functions of Quality while providing additional support to the other senior managers. Specifically, under the general direction of the QC Assistant Manager, he/she is responsible and has commensurate authority for the following: RESPONSIBILITIES: Essential Functions: -Effectively monitoring and enforcing compliance with the company's SOPs and cGMPs. -Overseeing and approving the clearing of production lines for the startup of production. -Overseeing that the requirements for Level I or Level II cleaning are met. -Execute validation activities as required by Protocols and Master Batch Records. -Perform Swab Testing on Packaging Equipment and Samples as per Multi-Pak, Client, Certification and Cleaning Validation requirements. -Verifying that the correct bulk and components were issued. -Confirm that packaging is completed according to specifications. -Responsible for completing quality checks. -Completing paperwork per SOP and Client’s requirements. -Responsible for accepting or rejecting all in process or finished goods during inspections. -Ensuring that all quality and production documentation is properly completed and signed. -Investigating any production or inventory discrepancies when they arise. -Responsible for collecting and labeling Multi-Pak and Client samples as specified on the Master Packaging Specifications and Master Batch Record for each lot. Collected samples must be issued to the quality office or when required, shipped with the finished product. -Audits packaging lines to ensure all personnel are adhering to Multi-Pak procedures and policies; including but not limited to, following Personal Hygiene and PPE requirements, cGMP’s and Good Documentation Practices. Nonessential Functions/Demands: -Training line operators on quality requirements and properly executing the requirements of the job. -Working on the production line, when required. -Perform other related duties as assigned. Requirements: -A high school graduate with experience in quality in a packaging company. -Bi-lingual is a plus (English/Spanish). -Attention to detail a must. REPORTING RELATIONSHIP: -Manager: QC Assistant Manager -Managerial Responsibility: None PHYSICAL/MENTAL DEMANDS: -Must be able to lift-up to 20 pounds on occasion. -Must be able to remain in the stationary position for up to 30% of the time. -Must be able to walk or stand up to 100% of the time. -The person in this position is sometimes required to function in narrow aisles or passageways while walking throughout the production area. -The person in this position will need to occasionally kneel, climb, crawl, climb and/or reach to complete their job duties. -The person in this position is required to communicate with all other departments and must be able to exchange accurate information in these circumstances.

Job DescriptionProviding Engineering and Manufacturing solutions since 1955, Triangle specializes in precision engineering and manufacturing of highly complex, tight-tolerance machined parts and assemblies. Triangle continues to thrive in more than 107,000 square feet over four state-of-the-art facilities at our Upper Saddle River, NJ campus. As a family-owned company, we foster a workplace that supports customer-driven, growth-oriented values and has a passion for surpassing expectations. We invest in our associates and create a supportive, team-based environment for learning, innovation, and advancement. Triangle is not only a family-run business; it's also a place where our associates feel like family. We believe in the same values and bring the same passion to our work each day to make a difference in people's lives. SUMMARY Develop and implement custom software solutions that drive business objectives through process automation and the synergies of interconnected systems. Work with cross-functional teams to solve operational challenges and translate business requirements into application design and features while providing the organization with a platform for making data-driven decisions. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. • Develop, implement, and support custom software applications., • Manage an application through the entire software development lifecycle., • Work cross-functionally with SME teams to develop processes and translate business requirements into application design and features., • Work strategically to automate internal processes and solve operational challenges that drive business objectives through technology., • Foster an environment of collaboration and continuous improvement by establishing feedback loops with internal customers and users., • Ensure solutions are performant, scalable and follow best practices., • Thoroughly test and debug applications including managing the software validation process., • Work with IT and others to promote technology within the organization and integrate with other systems as needed., • Continue to develop and enhance knowledge and proficiency in applicable technologies and platforms. Remain up to date on industry trends and best practices., • Simultaneously manage multiple priorities while supporting current applications. SUPERVISORY RESPONSIBILITIES This position has no supervisory responsibilities. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience Bachelor's degree from a four-year college or university and 2-3 years of experience (depending on job-level), or an equivalent combination of education and experience. • Ability to read, write and speak English fluently., • Knowledge of at least one programming language and related frameworks/libraries (JavaScript, Python, Ruby, .NET, etc.), • Experience with software design and development., • Experience with data-driven applications and relational databases (SQL Server, MySQL, FileMaker, etc.), • Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams., • Data-driven and curious, with a passion for problem solving and learning., • Detail-oriented and organized with the ability to multi-task and establish priorities in a fast-paced, changing environment.Desired, • Experience with modern web development tech stacks., • Experience developing dashboards and other BI tools., • Experience with ERP systems and ERP integrations., • Experience with Microsoft based development environments (.Net, SQL Server)., • Experience with FileMaker Pro., • Experience developing software in the manufacturing industry. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; sit; and use hands to finger, handle, or feel. The employee is occasionally required to reach with hands and arms. Specific vision abilities required by this job include close vision, depth perception, and color vision. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet and occasionally loud. Triangle does not sponsor for employment visa status. Triangle is proud to be an equal opportunity employer. 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. Powered by JazzHR tGcoElLTvC

Job Description Full-time tenure track faculty member in the Dental Hygiene program that includes didactic, clinical, laboratory, simulation instruction. Coordinates, plans, organizes, and teaches through classroom instruction and online education for selected areas of discipline. Creates and delivers engaging learning experiences for students to stimulate interest in subjects taught and to foster effective knowledge acquisition and communication. Promotes active inquiry, problem solving, digital literacy, and related decision making through the design and implementation of courses and teaching methodologies. Advises students and provides instructional support outside of class time as needed to foster student success Position Summary Responsibilities include but are not limited to: • Coordinates, plans, organizes, and teaches through classroom, lab and/or clinical instruction, simulation, and online education for the Dental Hygiene Program; teaching schedule may include courses in the day, evening, or on weekends on any College campus as assigned., • Creates and delivers engaging learning experiences tailored to students’ learning styles to stimulate interest in subjects taught and to foster effective knowledge acquisition and communication., • Promotes active inquiry, problem solving, information validation and related decision making through the design and implementation of courses and teaching methodologies., • Assesses student success and learning outcomes; serves as an academic advisor and provides instructional support outside of class time as needed to foster student success., • Participates in program and curriculum review, assessment, development and student learning outcomes initiatives., • Recommends textbooks and other instructional materials including classroom and laboratory equipment to the Academic Department Chair; assists in the College’s library collection development by selecting, evaluating, and weeding library resources in each appropriate discipline., • Keeps students continually informed and updated concerning feedback on their progress and work produced, course content, requirements, evaluation procedures and attendance requirements., • Demonstrated experience utilizing technology and on-line management systems and simulation to enhance student learning objectives and program assessment outcomes., • Participates in the development of the documentation for the Commission on Dental Accreditation self-study and annual reports and site visits., • Maintains accurate and complete scholastic records and other appropriate documentation., • Assists with the recruitment, retention and registration of students., • Participates on various committees and in selected local, state, regional, and national professional activities and organizations., • Maintains active involvement in the co-curricular activities of the College., • Participates in the tenure process as defined by the faculty contract., • Performs additional tasks or duties as assigned by the Dean of Health Professions or other designated management. SPECIAL SKILLS AND QUALIFICATIONS Education: Master's degree in Dental Hygiene or related area required. Graduate of a CODA accredited Dental Hygiene Program. Experience: Minimum of five years of current experience as a registered dental hygienist and teaching experience in a CODA accredited Dental Hygiene program. Licenses: Current NJ Dental Hygiene license required. Current BLS-Healthcare Provider with AED Certification. Other: Position will require ability to work at any of the College’s locations – Paramus, Lyndhurst and Hackensack. Knowledge, Skills and Abilities: Demonstrates experience utilizing technology and on-line management systems and simulation to enhance student learning objectives and program assessment outcomes Current CODA Accreditation experience Knowledge of competency-based education Commitment to continuous assessment of the teaching and learning process and outcomes Demonstrated experience with the Typhon clinical tracking software or willingness to learn Demonstrated experience with the CANVAS learning management platform or willingness to learn Demonstrated experience with Eaglesoft practice management software or willingness to learn Commitment to continual professional growth and development Current Educational Methodology as required by CODA SALARY AND BENEFITS • Annual Salary ranges from $65,643.64-$96,567.21, • NJ Educator's Health Plan with Free Dental and Vision, • NJ State Pension Plan, • 403B Plan, • Tuition Reimbursement, • 15 sick days, 5 personal days, 3 partial sick days Bergen Community College 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 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 DescriptionTitle: Stability Coordinator Reports to: Manager, Quality Systems/Validations Department: Quality Assurance Organizational Relationships: Batching & Filling/Assembly areas, Customer Reps, Customers, Approved Testing Labs and Warehouse/Shipping personnel. Responsibility Summary: The Stability Coordinator is responsible for managing all aspects of stability sample preparation, submission, and documentation in compliance with approved protocols and cGMP standards. Key duties include coordinating with testing laboratories, maintaining accurate logs, monitoring stability chambers, and preparing detailed reports for quality review. The role ensures timely tracking of test results, supports regulatory requirements, and promptly reports any out-of-specification findings to the Quality team. Responsibilities: The Stability Coordinator is responsible for supporting the company's business events through a variety of tasks, including: • Reviews batch and finished product stability samples using approved stability protocol, current product specifications and sample submission forms., • Prepares stability samples and submission documents., • Co-ordinates with testing labs as required., • Facilitates maintenance of awareness and compliance with cGMP and safety regulations in production, manufacturing and related areas., • Maintain current logs (with sent dates, result due dates, result receipt dates, etc) for all stability samples to support approved protocols., • Daily / Periodic monitoring and documentation of (a) Walk-in; (b) Reach-in; and (c) Freeze/Thaw chambers and their parameters such as temperature and humidity, PM, calibration, Water supply, etc., • Must be familiar and current with Englewood SOP 1-050 (Operating, Maintaining and Monitoring of Stability Chambers); SOP 1-033 (Stability Testing for Drug Products) and Englewood Lab Quality Form, EQF 206, 207, 022 and EQF 121., • Prepares stability sample submission documents to cover long term, accelerated, freeze-thaw, intermediate (if applicable), preservative challenge test (PET)., • Maintains stability reports including compatibility, analytical method validation, and PET., • Assemble on-going, in-progress, and completed reports for review by QC Manager or designee., • Maintain tracking logs and correspondence to support stability sample submission to approved labs and for customer evaluation., • Immediately notify Quality personnel if out-of-specification (OOS) is observed in stability test results., • Periodically review stability logs for completeness., • Ensure that only most current versions of product specifications are used for product testing by the approved labs., • Ensure on-time submission of samples and receipt of results/customer approvals., • Maintains awareness and compliance with US FDA, ICH Stability, GMP and safety regulations in performing job duties., • All other functions and duties as may be assigned by immediate supervisor. Qualifications: • Associate’s degree (2-year college degree) required., • Experience in cosmetic, device, food or pharmaceutical inspection process preferred., • Good math skills., • Ability to read and interpret internal and external sampling plans and effectively report results., • Effective communication skills with internal and external customers., • Ability to lift and carry up to 10-15 pounds. This position is Full-Time, Onsite in Totowa, New Jersey, five days per week in the office (9:00AM - 6:00PM) Compensation & Benefits: The approximate pay range for this position is $50,000 - $60,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. The benefit package includes: • Medical, Dental, Vision, Life, • PTO, • Special Paid Leave for employees’ personal events, • Company Paid Holidays, • 401(k) employer match, • Year-End Gift Powered by JazzHR CsigK53ac5

Job Description Welcome to Outerspace's official job board, where opportunities are endless. Explore career openings and join our dynamic team. Discover fulfilling roles across various functions and locations within Outerspace. Your next career move starts here - apply today! Inventory Control & Warehouse Operations Supervisor Outerspace is a new type of Ops Center. We come from the brand side and have built and led operations for companies like Steve Madden, Prada and Nice Laundry. We leverage the latest technology to support our high growth brands and their daily operations. Outerspace provides a number of services including, but not limited to, warehousing and fulfillment, customization and light manufacturing, and product photography. We are seeking a highly motivated and detail-oriented Inventory Control & Warehouse Operations Supervisor to join the team. This role is responsible for overseeing inventory accuracy, warehouse optimization, replenishment processes, system integrity, and operational efficiency within a fast-paced warehouse and distribution environment. The Inventory Control & Warehouse Operations Supervisor leads inventory-related activities, warehouse organization initiatives, and continuous improvement projects to ensure operational excellence and customer satisfaction Reports to: Senior Operations Manager/Operations Manager Compensation: $65,000 - $75,000 DOE Responsibilities: Warehouse Operations: • Oversee and manage replenishment activities to ensure pick locations maintain optimal inventory levels., • Perform pick location stock validation to ensure inventory accuracy and product availability., • Manage slotting optimization to maximize warehouse efficiency and improve travel paths., • Coordinate pick consolidation and reserve consolidation activities to improve operational flow and space utilization., • Lead and support 5S implementation initiatives throughout warehouse operations., • Monitor warehouse organization and storage utilization to improve operational productivity., • Support inbound and outbound operations through warehouse process optimization., • Collaborate with Operations, Inventory Control, and Customer Service teams to support daily workflow execution. Inventory Control: • Develop, manage, and execute the Cycle Count Program to maintain high inventory accuracy levels., • Supervise cycle counting activities, including empty location validations., • Coordinate and execute Wall-to-Wall Inventory activities as required., • Manage damage control processes and ensure proper disposition of damaged inventory., • Perform system reconciliations between physical inventory and WMS/system records., • Review and approve inventory adjustments while maintaining inventory adjustment control procedures., • Generate and analyze daily inventory and operational reports., • Monitor product aging, including lot-controlled inventory and expiration-sensitive products., • Monitor SQF measurements and inventory compliance standards., • Validate warehouse space utilization and inbound capacity availability., • Maintain and update SOPs, work instructions, and process flow documentation. Operational Excellence: • Track and monitor KPIs related to inventory accuracy, replenishment efficiency, location utilization, productivity, and operational compliance., • Identify operational bottlenecks and implement corrective actions and process improvements., • Ensure compliance with company policies, SOPs, safety procedures, and inventory control standards., • Conduct audits and validations to maintain system and physical inventory accuracy., • Support peak season planning, operational scaling, and cross-functional projects. Safety: • Ensure work areas are safe, clean, and compliant with OSHA and warehouse safety standards., • Conduct daily safety observations and promote safe work practices., • Support warehouse housekeeping and 5S standards across all operational areas. People Management: • Communicate effectively with warehouse associates, leads, supervisors, and management teams., • Train, coach, and mentor associates on inventory processes and warehouse procedures., • Monitor attendance, productivity, and compliance with company policies., • Support conflict resolution and escalate operational or personnel concerns when needed., • Lead team meetings, performance discussions, and operational updates.d Qualifications and Education Requirements: • High School Diploma / GED required; associate or bachelor's degree in supply chain, logistics, or a related field preferred., • 2–5 years of warehouse or fulfillment center experience, with at least 1 year in a supervisory role, • Proficiency with warehouse management systems (WMS), RF scanners, handheld android devices, • Strong leadership, communication, organizational, and problem-solving skills., • Ability to work in a fast-paced environment with a sense of urgency and attention to detail., • Comfortable with physical demands including standing, walking, and lifting up to 50 lbs., • Ability to work flexible hours, including weekends and holidays, as needed, • Proficient with technology and software, such as Google Suite, Microsoft Office, Slack, • Bilingual (English, Spanish), strongly preferred Benefits: • Paid Time Off, • Paid Holidays, • Insurance (medical, dental, vision), • HSA & FSA, • 401(K) matching, • and more! Outerspace will never extend a job offer without first conducting a formal interview process, which includes multiple virtual and/or in-person interviews. We will never request sensitive personal information — including Social Security numbers or banking details — prior to making a formal offer. All legitimate Outerspace job postings are listed exclusively on this page. Any posting not found here is not authorized by Outerspace and should be treated as fraudulent.

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)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.