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Description: 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 Clinical Research Nursing Instructor is responsible for the orientation, continuing education, staff development and continuous process improvement of clinical research nursing staff, team members, patients, and the network research community, as applicable, across the health network and in collaboration throughout the NCI Consortium designation with Georgetown University, when applicable. Responsibilties: • Results and identifies training opportunities based on ongoing needs assessment and analysis., • Develops and designs educational offerings based on needs assessments and/or organizational/departmental requirements, the educational process, and principles of adult education., • Promotes and facilitates performance improvement initiatives consistent with the goals and missions of the health network., • Integrates educational opportunities and develops ongoing education relevant to the coordination of research-related regulations and guidelines., • Supports staff and provides education specific to the development, maintenance, and reporting of findings for clinical trials., • Supports and trains research staff in developing, applying and maintaining research computerized provider order entry sets., • Evaluates the effectiveness of educational offerings, including, but not limited to, ensuring that knowledge and/or skills learned are being applied on the job and have an impact on staff performance in meeting departmental/ organizational goals; conducting surveys to gauge team members` knowledge of various topics; collaborating with the compliance team to discuss audit findings., • Participates in annual review and revision of staff orientation., • Coordinates comprehensive, unit-specific programs for research team members, inclusive of core competencies for staff in assigned areas, as needed., • Monitors completion of educational requirements and validation of skills, as necessary, and records/files appropriately., • Communicates progress and performance to manager, as appropriate., • Assists in an annual review of mandatory education and core competencies based upon requirements of NJDOH, JCAHO, Hackensack Meridian Health, and any other applicable state, federal, or institutional agencies., • Documents all educational events, inclusive of objectives, evaluations, and attendance, and develops metrics to track them., • Assists staff in planning and developing grand rounds and professional journal clubs, as requested., • Participates in the coordination of education programs generated by the HMH Research Institute and/or assigned department., • Collaborates with team members to enhance educational support in assigned areas., • Collaborates with team members in other areas to address any research or clinically related educational needs and facilitate staff education., • Acts as a mentor for students, interns, or other individuals, as applicable., • Evaluates, with input from preceptors, the performance of new staff., • Trains and/or coordinates research team members on various clinical skills, including CPR, EKG administration, phlebotomy, and potential other areas., • Assists in drafting and disseminating research-related announcements, memos, website content, and newsletter articles., • Assists in identifying and applying for educational grants, when applicable., • Other duties and/or projects as assigned., • BSN Graduate of a NLN/AACN accredited program in nursing., • 3 years clinical research experience., • Adheres to the American Nurses Association standards., • Strong attention to detail and customer service focus is required., • Excellent communication, organizational, presentation, documentation, and interpersonal skills are required., • Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential., • Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms. and voicemail is required., • Review and comply with all relevant HMH and Business Unit policies and procedures, and local, state, and Federal laws and regulations. Education, Knowledge, Skills and Abilities Preferred: • Education on human subject research and GCP (CITI Training and Certification)., • Knowledge of clinical trials and the regulation (local, state, and federal) of such., • Familiarity with basic scientific and healthcare principles and terminology., • Ability to work in a fast-paced environment and manage competing tasks and demands. Licenses and Certifications Required: • NJ State Professional Registered Nurse License., • AHA Basic Health Care Life Support HCP Certification within 60 days of entering position. Licenses and Certifications Preferred: • Certified Clinical Research Professional or Certified Clinical Research Professional or Certified Clinical Research Coordinator.

ABMG/ABP-certified, specifically in Molecular Genetics. The successful candidate will have experience in molecular genetic laboratory testing, clinical assay development and validation, equity control and quality assurance, interpretation of lab test results, reporting and consultation with physicia

A company is looking for a Manager, Data Science and Analytics to lead analytics initiatives and build scalable models that drive business impact. Key Responsibilities Lead the development, validation, and deployment of predictive and statistical models Analyze structured and unstructured data us

A company is looking for a Senior Test Engineer to support the Grants Management Modernization program by performing Independent Verification and Validation and third-party Agile testing services. Key Responsibilities Execute independent verification and validation (IV&V) activities for the GM

Key Responsibilities Own the hardware test & validation domain, including automated test systems and production-line validation Develop end-to-end production test sequences and maintain scalable validation tools from prototype to mass production Collaborate with cross-functional teams to align t

A company is looking for a Clinical DRG Auditor who is responsible for performing DRG validation reviews of medical records to ensure accuracy in coding and documentation.Key Responsibilities Perform audits of medical record documentation to determine the accuracy of diagnosis and procedure codes

Key Responsibilities: Lead and mentor a high-performing team of product marketers focused on delivering customer-centric solutions Collaborate cross-functionally to develop, position, and launch products globally Drive go-to-market excellence, overseeing market validation, messaging, positioning

A company is looking for a Project Manager Non Tech 1.Key Responsibilities Coordinate data operations, reporting, and cross-functional project activities for business planning and monetization initiatives Support launch data validation, system updates, and operational compliance reporting Develo

Job Description Our client in Fairfield, NJ is looking for a Validation Engineer for a Full time position. Pay is $80k-$95k annually DOE • 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 Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. • Develop and maintain training program within Quality Control which includes, onboarding and continuous training, • Manage deviations, CAPAs, change controls and document review to ensure compliance, • Ensure OOS investigations are completed adequately., • Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories, • Identify resources needed for training and compliance and build team accordingly, • Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements., • Monitor effectiveness of CAPAs, change control activities, and audit observation closure., • Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators, • Responsibilities include 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. REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory experience in a cGMP environment a must, • 3-5 years’ experience in the pharmaceutical, biologics ore related industry, • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position, • Sound understanding of cGMPs, • Experience in laboratory training and compliance, • External laboratory management experience, • Strong knowledge of testing methodologies, philosophies, method validation and method transfers., • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Experience with laboratory training programs, • Knowledge of GMP requirements, • Excellent organizational and leadership skills, • Outstanding analytical problem-solving abilitiesWhile 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. 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 UI/UX Designer (Web & App) Location: Newark, NJ (On-site, Full Time) Salary: $80,000 - $120,000 About the Role We're looking for a junior-to-mid UI/UX Designer who loves creating clean, modern, user-friendly digital experiences. You'll help design both web and mobile interfaces for internal tools, customer-facing platforms, and new digital features. This is a great fit for someone who enjoys bringing ideas to life visually, working with cross-functional teams, and creating designs that are not only beautiful but also practical and intuitive. If you're creative, organized, and excited to grow in a fast-moving environment — we'd love to see your work. Portfolio required with application. What You'll Do • Turn ideas and requirements into simple, clear wireframes and workflows, • Create polished mockups and prototypes using Figma, • Work with product owners and developers to ensure designs are realistic and buildable, • Keep designs consistent, reusable, and aligned with existing style patterns, • Participate in planning sessions to clarify user needs and design constraints, • Test your designs, gather feedback, and make improvements as needed, • Support small UX research tasks, usability checks, and quick validation loops What You Bring • Experience designing web or mobile UI in Figma, • Strong eye for clean layouts, typography, spacing, and visual hierarchy, • Ability to understand user flows and translate them into simple experiences, • Good communication skills — comfortable discussing ideas with different teams, • Organized, detail-oriented, and able to handle feedback well, • Bonus: experience creating test cases, scenarios, or basic UX validation work Why You'll Love This Role • Hands-on work with real products and real users, • Room to grow your design and UX skills, • Friendly, collaborative environment, • Opportunity to leave your mark on multiple digital platforms How to Apply If you're excited about UI/UX, love designing clean experiences, and want to grow your career — send us your resume and portfolio. Email Resume + Portfolio: Apply Online: Refer a friend, get up to $1000!

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

Job DescriptionQuality 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 Public Safety RF Engineer Location: Clifton NJ Description C Squared Systems, LLC is an RF engineering, consulting, and software development company specializing in providing services for seamless wireless coverage from RF analysis to design and implementation of DAS systems and Wi-Fi networks to remote monitoring and management of complex multi-vendor environments. Site Portal®, a customizable Web-based software, was engineered by C Squared Systems to remotely monitor and manage these complex multi-vendor environments. Since 1999, C Squared Systems has executed turnkey in-building wireless solutions using state-of-the-art analysis tools to deliver RF solutions that exceed project scope and customer expectations. Our experience, technical expertise, and diverse projects in the wireless realm have allowed C Squared Systems to continually evolve as new technologies are developed and the demands of our customers change. C Squared Systems is currently seeking a Public Safety RF Engineer responsible for public safety system engineering functions relating to RF/Wireless communications pertaining to In-Building and outdoor, passive and active (Distributed Antenna System) systems. The incumbent will work hand in hand with senior public safety RF engineers in various aspects of DAS design, installation, commissioning, testing, troubleshooting and remote monitoring. The incumbent will also perform various operational support functions such as parts procurement, equipment repair/return, inventory, and documentation. Domestic travel will be expected approximately 25-50% of the time, with the majority of that being within the Greater New York area, but does include other markets as needed. Primary Responsibilities: • Design of Radio Frequency (RF) wireless communication systems and technology, • Experience working with large county or statewide P-25T, P-25C, and analog systems, • Develop Request for Information (RFIs) and Requests for Proposals (RFPs) evaluate solutions, manage implementations, and perform Independent Verification & Validation, • Coordinating with AHJ’s, FCC License holders, Carriers, End Users, Facility Managers, and Equipment Vendors, • Supporting the efforts of our technicians and engineers and directly supporting customers, • Ensuring customer satisfaction, • Work hands on with system components such as antennas, fiber optics, coax, and RF amplifiers and receivers, • Radio Frequency Exposure Studies, Intermodulation and Interference Analysis, • Multi-task projects on a day-to-day basis, • Travel to various job sites within Greater New York and other markets., • Strong background in public safety wireless communications, • Experience working with large county or statewide P-25T, P-25C, and analog systems, • Experience with RF Coverage modeling, RF design, and optimization, • Experience with LMR site equipment configuration and test, • Experience in land mobile radio, project management skills, knowledge of database reporting tools., • Familiarity with Public Safety organization operations, • Knowledge of other wireless technologies such as TETRA, GSM, UMTS, CDMA, WiFi, LTE and embedded systems, • Knowledge of microwave, circuit based, and fiber backhaul., • Knowledge of IP-based dispatch consoles and voice recorders, • Professional level certification in Wireless Communications (e.g., ETA, CWNA, Microsoft Wireless Communications Engineering Technologies, GROL Certification), • Experience or familiarity with radio frequency devices and/or systems is highly desirable., • Experience troubleshooting public safety DAS systems including ADRF, Comba, Zinwave, etc., • Familiar with the basics of IP Networking, • Multifaceted Professional capable interfacing with customers, • Proficient in basic computer applications (MS Outlook, MS Word, MS Excel, etc.), • Ability to learn quickly and understand technical materials, • Ability to shift gears quickly as priorities change, • A solid understanding of fundamental engineering principles and the ability to effectively work on multiple engineering projects simultaneously, • Requires knowledge of radio frequency and fiber optic communication technology, • Must be able to work effectively within a diverse work force including engineers, project managers, skilled craft workers, consultants, customers, and regulatory agency personnel, • Must have strong interpersonal and communications skills to be able to effectively communicate complex issues with peers, supervisors, and managers. Must be authorized to work in the US, be willing to travel up to 50%, have a clean driving record and be able to pass a company background check., • A minimum of a bachelor’s degree, preferably in electrical engineering or similar discipline with at least 5 years Land Mobile Radio (LMR) engineering experience. Master’s degree preferred. An equivalent combination of advanced education, training, and experience will be considered.

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

Job DescriptionCoreWeave is The Essential Cloud for AI™. Built for pioneers by pioneers, CoreWeave delivers a platform of technology, tools, and teams that enables innovators to build and scale AI with confidence. Trusted by leading AI labs, startups, and global enterprises, CoreWeave combines superior infrastructure performance with deep technical expertise to accelerate breakthroughs and turn compute into capability. Founded in 2017, CoreWeave became a publicly traded company (Nasdaq: CRWV) in March 2025. Learn more at You'll Do: The Fleet Reliability Operations team is responsible for the day-to-day provisioning, management and uptime of CoreWeave's ever-expanding fleet of server nodes. Playing a central role in CoreWeave's growth strategy, this team is on the front line for configuration, updates and remote troubleshooting of our highest tier of supercomputing clusters and their networking, delivery platforms and tools dependencies. You will be in a daily battle with the forces of entropy to maximize the number of nodes CoreWeave can deliver to customers. We are seeking curious, creative and persistent problem solvers to join our Fleet Reliability Operations team to help us drive batches of server nodes through our provisioning and validation processes while efficiently and effectively troubleshooting node or cluster problems as they arise. This individual will join a team of committed engineers working to deploy nodes as fast as they can be racked and turned on. • Configure and maintain large-scale high-performance supercomputing clusters running state-of-the-art GPUs, • Troubleshoot hardware and software issues; escalate and coordinate as needed with data center, network, hardware and platform teams to drive resolution, • Monitor and analyze system performance and take appropriate remediation actions for cloud health, • Approach your work with flexibility and optimism anticipating shifting business and technical priorities, • Create and maintain documentation of team processes, knowledge and best practices for system management, • Think critically about your day-to-day work and work collaboratively to improve team processes and efficiency, • Strong understanding of Linux system administration and internals, • Ability to troubleshoot hardware and software issues and perform system maintenance tasks consistently and reliably, • 2 + years of experience troubleshooting or administering data center or on-prem infrastructure (servers, storage, network or a mix), • Grafana, Prometheus, promsql queries or similar observability platforms, • Data center environments including server racks, HVAC systems, fiber trays, • Kubernetes administration, • HPC - administering GPU-related workloads What We Offer The range we've posted represents the typical compensation range for this role. To determine actual compensation, we review the market rate for each candidate which can include a variety of factors. These include qualifications, experience, interview performance, and location. In addition to a competitive salary, we offer a variety of benefits to support your needs, including: • Medical, dental, and vision insurance - 100% paid for by CoreWeave, • Company-paid Life Insurance, • Voluntary supplemental life insurance, • Short and long-term disability insurance, • Flexible Spending Account, • Health Savings Account, • Tuition Reimbursement, • Ability to Participate in Employee Stock Purchase Program (ESPP), • Mental Wellness Benefits through Spring Health, • Family-Forming support provided by Carrot, • Paid Parental Leave, • Flexible, full-service childcare support with Kinside, • 401(k) with a generous employer match, • Flexible PTO, • Catered lunch each day in our office and data center locations, • A casual work environment While we prioritize a hybrid work environment, remote work may be considered for candidates located more than 30 miles from an office, based on role requirements for specialized skill sets. New hires will be invited to attend onboarding at one of our hubs within their first month. Teams also gather quarterly to support collaboration California Consumer Privacy Act - California applicants only CoreWeave is an equal opportunity employer, committed to fostering an inclusive and supportive workplace. All qualified applicants and candidates will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information. As part of this commitment and consistent with the Americans with Disabilities Act (ADA), CoreWeave will ensure that qualified applicants and candidates with disabilities are provided reasonable accommodations for the hiring process, unless such accommodation would cause an undue hardship. If reasonable accommodation is needed, please contact: . Export Control Compliance This position requires access to export controlled information. To conform to U.S. Government export regulations applicable to that information, applicant must either be (A) a U.S. person, defined as a (i) U.S. citizen or national, (ii) U.S. lawful permanent resident (green card holder), (iii) refugee under 8 U.S.C. § 1157, or (iv) asylee under 8 U.S.C. § 1158, (B) eligible to access the export controlled information without a required export authorization, or (C) eligible and reasonably likely to obtain the required export authorization from the applicable U.S. government agency. CoreWeave may, for legitimate business reasons, decline to pursue any export licensing process.

Job DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional 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.Able to utilize equipment in manufacturing are as well QC laboratories.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 Senior Health Economics Analyst Location: Remote Supervisor/Reporting to: Director, Performance Reliability Job Purpose: The Senior Health Economics Analyst is responsible for identifying and delivering data-driven insights and analytical support to senior leadership of IVIRMA North America. Success in the role will be achieved through the ability to leverage both qualitative and quantitative data to create business intelligence to guide strategic execution. This role serves to create and deliver reliable, insightful and actionable insight to improvements and opportunities for performance reliability – supporting our teammates in delivering a world-class patient experience. Essential Functions and Accountabilities: • Supports the design, development, and implementation of reporting to support data-driven decision making and insight. Partners with finance, commercial and business leaders to translate needs and requirements into dashboards and reporting with high utility., • Assists in the design and evaluation of organizational KPIs for potential replacement or evolution as the organization grows., • Prepares and analyzes medical cost and leading indicator data to develop presentations for executive and senior leadership. Interpret results and articulate actionable recommendations that maximize outcomes and ensures organizational targets are met., • Tracks performance of key performance indicators for outlined regions and teams as requested., • Supports finance, commercial and operations in the annual and multi-year planning processes including market durability, • Performs data validation to ensure completeness and accuracy of queries and reports and reconciles discrepancies., • Participates in the maintenance of existing queries and reports, re-writing and enhancing these queries as needed., • Participates in the presentation of complex concepts and results to end users and stakeholders Academic Training: • Bachelor’s degree in Computer Science, Information Services, or other technical or healthcare field – highly preferred, • Studies level: University Education (Bachelor’s Degree), • Studies area: Computer Science/Engineering or other related field Position Requirements/Experience: • Experience working in medical/healthcare industry - preferred, • Knowledge of data collection, storage, and maintenance concepts - required, • Knowledge in predictive modeling - a plus, • Database organization, design, and maintenance skills., • Ability to troubleshoot database programs Technical Skills: • Knowledge of PowerBI - required, • Knowledge of Microsoft Office Suite: Word, Excel (Pivot Tables/Look-Ups), Access, and OneNote – required, • Knowledge of Tableau - preferred IVI-RMA offers a comprehensive benefits package to all employees who work a minimum of 30 hours per week. • Medical, Dental, Vision Insurance Options, • Retirement 401K Plan, • Paid Time Off & Paid Holidays, • Company Paid: Life Insurance & Long-Term Disability & AD&D, • Flexible Spending Accounts, • Employee Assistance Program, • Tuition Reimbursement About IVIRMA Global: IVIRMA is the largest group in the world devoted exclusively to human Assisted Reproduction Technology. Along with the great privilege of providing fertility care to our patients, IVIRMA embraces the great responsibility of advancing the field of human reproduction. IVIRMA Innovation, as one of the pillars of IVIRMA Global, is a renowned leader in fertility research and science. Check out our websites at: & EEO “IVIRMA is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind: IVIRMA is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at IVIRMA are based on business needs, job requirements and individual qualifications, without regard to race, color, religion and/or belief, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. IVIRMA will not tolerate discrimination or harassment based on any of these characteristics. IVIRMA encourages applicants of all ages.”

Job DescriptionCompany Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is safer and more secure than the one before. We are a company built on the foundation of challenging and disrupting the way things are done, and we’re looking for innovators who are as committed to shaping the future of cybersecurity as we are. Who We Are This role is remote, but distance is no barrier to impact. Our hybrid teams collaborate across geographies to solve big problems, stay close to our customers, and grow together. You will be part of a culture that values trust, accountability, and shared success where your work truly matters. Job Description Your Career The Solutions Consultant is the evolution of the traditional Sales Engineering role, aligning how we best serve our customers in understanding their environment, providing solution guidance and ensuring value realization in their investment with Palo Alto Networks. As a Solutions Consultant you provide technical leadership and expertise and guidance in your customer’s security transformation journey. You will play a key role in defining technical solutions that secure a customer’s key business imperatives and ensuring value realization of their investment with Palo Alto Networks. You evangelize our industry leadership in on-prem, cloud, and security operations services that establish PANW as your customer’s cybersecurity partner of choice. Your Impact • Curiosity is core to the Solutions Consultant role, and you see complex problems as opportunities to learn and deliver innovative solutions! You define your impact by:, • Meeting and exceeding sales quotas by building and implementing strategic, technical account plans that target cross-platform solutions, • Understands Key customer business requirements and has the ability to position, demonstrate and create high level designs across the entire PANW portfolio solutions creating business value for customers, • Ability to drive customer adoption of Palo Alto Networks Platform. Building customer relationships by helping customers achieve increased productivity, operational efficiency, security efficacy, and greater flexibility to innovate, • Conducting discovery to understand and articulate the key technical, operational, and commercial imperatives of your prospects and customers, • Working closely with Professional Services, Customer Success and Specialist teams to ensure overall customer implementation and adoption of solutions, • Demonstrating strong communication skills, influencing through effective presentations and customer-specific demos, and conducts technical engagements and workshops that are clear and impactful, simplifying complex ideas for various audiences, • Leading successful technical validation efforts based on best practices to ensure technical win in assigned opportunities, • Demonstrates Cross functional leadership driving collaboration and orchestrating supporting resources (Specialists, Channel Resources, Customer Support) to ensure a one-team approach that demonstrates a cohesive strategy, • Promoting end-to-end solutions that include PANW and/or partner professional services to ensure customers realize business value sooner, • Understanding the competitive landscape and effectively differentiating PANW's leadership in the cybersecurity space, • Continuously investing in yourself to develop technical and professional skills that drive your ever-increasing contributions to success of our customers while actively participating within the Solutions Consultant community and at industry events, • Identifying technical stakeholders and cultivating relationships with key personas to build and drive a security architecture transformation roadmapQualifications Your Experience • 6+ years experience in pre-sales/sales engineering, • Understanding of data networking and/or modern application design and cloud architectures, • Experience in delivering cybersecurity solutions that solve technical challenges and influence new business initiatives is preferred, • Influencing and gaining buy-in from key stakeholders, either in a customer-facing or internal role; prior experience in a pre-sales role is ideal, • Creating and delivering technical presentations, workshops, or technical validation engagements, • Experience in selling, designing, implementing, or managing one or more of the following solutions: Network Security, SASE, SaaS, CNAPP and/or SOC Transformation Technologies, • Partnering with Customer Support functions to ensure successful implementation and adoption of sold solutions, • Experience in complex sales involving long sales processes with multiple buying centers and multi-product solutions are preferred, • This is a field sales position where travel requirements may be required to support in person customer meetings, please discuss with the recruiter on the specifics for this position., • Proficient in English Additional Information The Team Our Solutions Consultant team members work hand-in-hand with large organizations around the world to keep their digital environments protected. We educate, inspire, and empower our potential clients in their journey to transform their security architectures. You are empowered with unmatched systems and tools and a team built on joint success. You won’t find someone at Palo Alto Networks who isn’t committed to your success, with everyone pitching in to assist when it comes to solutions, selling, learning, and development. Our Solutions Consulting community is driven by the mission to be our customers’ cybersecurity partner of choice, protecting their digital way of life. Compensation Disclosure The compensation offered for this position will depend on qualifications, experience, and work location. For candidates who receive an offer at the posted level, the starting base salary (for non-sales roles) or base salary + commission target (for sales/commissioned roles) is expected to be between $198000/YR - $273000/YR. The offered compensation may also include restricted stock units and a bonus. A description of our employee benefits may be found here. Our Commitment We’re problem solvers that take risks and challenge cybersecurity’s status quo. It’s simple: we can’t accomplish our mission without diverse teams innovating, together. We are committed to providing reasonable accommodations for all qualified individuals with a disability. If you require assistance or accommodation due to a disability or special need, please contact us at . Palo Alto Networks is an equal opportunity employer. We celebrate diversity in our workplace, and all qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or other legally protected characteristics. All your information will be kept confidential according to EEO guidelines.

Job Description We are looking for a skilled Staff Accountant to join our team in Livingston, New Jersey. This is a long-term contract position that offers the opportunity to work on-site Monday through Friday. The role involves handling a variety of accounting tasks, ensuring accuracy in financial processes, and supporting month-end close activities. Responsibilities: • Manage accounts payable processes, including invoice validation and payment processing., • Perform general accounting duties, such as journal entries and reconciliation., • Support inventory-related financial tasks, ensuring accurate record-keeping., • Handle month-end close procedures to ensure timely and accurate reporting., • Maintain and reconcile the general ledger to ensure data integrity., • Utilize Sage X3 and Microsoft Excel for accounting and reporting purposes., • Ensure compliance with company policies and accounting standards., • Assist with financial audits and prepare necessary documentation., • Provide insights and recommendations for process improvements within the accounting function., • Proven experience in accounts payable processes and general accounting., • Proficiency in journal entries and general ledger management., • Strong knowledge of month-end close procedures and financial reporting., • Expertise in using Sage X3 and Microsoft Excel for accounting tasks., • Familiarity with inventory-related accounting processes., • Ability to work independently and collaboratively in an environment that values attention to detail., • Excellent attention to detail and organizational skills., • Strong communication abilities to interact effectively with team members and stakeholders.

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 Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile 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 noisy. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility 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 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 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 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., • 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, • 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 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 NS Pharma is an EEO employer.

Job Description Cibo Vita, a leading food manufacturing company specializing in trail mixes, is seeking a detail-oriented and analytical Payroll Specialist to manage the company’s weekly payroll process for all hourly employees. This role is responsible for ensuring payroll accuracy, timeliness, and compliance, while also helping to streamline and automate payroll workflows to reduce manual process Requirements Payroll Management · Process and verify weekly payroll for all hourly employees across multiple departments and locations. · Review and approve employee timecards, ensuring accuracy in hours worked, overtime, and pay rates. · Prepare and validate payroll data, deductions, and adjustments prior to submission. · Handle off-cycle payments, pay corrections, and retroactive adjustments when necessary. Automation & Process Improvement · Identify manual payroll tasks that can be automated to improve efficiency and accuracy. · Develop templates, checklists, and audit tools to minimize errors and streamline recurring payroll processes. Data Management & Reporting · Maintain employee data within the payroll and HRIS systems, ensuring accuracy and confidentiality. · Prepare weekly payroll summaries and reports for HR and Finance leadership. · Conduct periodic audits to ensure compliance with wage and hour laws and internal policies. Compliance & Support · Ensure payroll practices comply with federal, state, and local laws and regulations. · Maintain proper documentation of all payroll transactions and approvals. · Serve as the primary point of contact for employee payroll inquiries, ensuring prompt and professional communication. Collaboration & HR Support · Coordinate with HR on employee onboarding, terminations, and changes that affect payroll. · Support HR projects related to timekeeping, attendance tracking, and data consistency. Qualifications: · Education: Bachelor’s degree in Accounting, Business Administration, or Human Resources preferred. · Experience: Minimum 3+ years of payroll experience (manufacturing environment preferred). · Skills: o Strong understanding of payroll principles, wage and hour laws, and tax regulations. o Proficiency in Paychex or other payroll systems. o Advanced Excel skills (formulas, pivot tables, and data validation). o Excellent organizational skills and strong attention to detail. o Ability to maintain confidentiality of sensitive information. o Bilingual in English and Spanish preferre

Job Description Our client is seeking a CMC Writer to join their team. & SUMMARY: • Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. JOB DESCRIPTION: • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files KEY RESPONSIBILITIES: • Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format., • Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals., • Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions., • Ensure compliance with FDA, EMA, and ICH guidelines and internal processes., • Collaborate with cross-functional teams to gather accurate technical information., • Identify and communicate potential regulatory risks; propose mitigation strategies. QUALIFICATIONS: • Education: Bachelor’s or advanced degree in Chemistry, Pharmaceutical Sciences, or related field., • Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management., • Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities., • Familiarity with global regulatory frameworks and eCTD submissions., • Excellent technical writing, communication, and organizational skills., • Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint). PREFERRED SKILLS: • Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings., • Ability to interpret and apply regulatory guidelines effectively., • Strong project management and stakeholder communication skills.

Job Description SUMMARY: • Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities., • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files, • Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format., • Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals., • Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions., • Ensure compliance with FDA, EMA, and ICH guidelines and internal processes., • Collaborate with cross-functional teams to gather accurate technical information., • Identify and communicate potential regulatory risks; propose mitigation strategies., • Education: Bachelors or advanced degree in Chemistry, Pharmaceutical Sciences, or related field., • Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management., • Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities., • Familiarity with global regulatory frameworks and eCTD submissions., • Excellent technical writing, communication, and organizational skills., • Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint)., • Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings., • Ability to interpret and apply regulatory guidelines effectively., • Strong project management and stakeholder communication skills.

Job DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to conduct investigation and CAPA processes., • Conduct investigation and identify true root cause using appropriate tools., • Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates., • Reviews and approves investigations and CAPAs when required;, • Collaborate with cross functional department to develop and track CAPA plans., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Other duties as assigned.REQUIREMENTS, • B.S in biological sciences or other relevant field of study., • Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Competencies/Candidate Profile, • Relevant 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 be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to work in a team-oriented environment., • Must be able to work occasional 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. 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 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 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 DescriptionCompany Description Vichara is a Financial Services focused products and services firm headquartered in NY and building systems for some of the largest i-banks and hedge funds in the world. Job Description Key Responsibilities Architecture & System Design * Architect, design, and lead multi-agent LLM systems using LangGraph, LangChain, and Promptfoo for prompt lifecycle management and benchmarking. * Build Retrieval-Augmented Generation (RAG) pipelines leveraging hybrid vector search (dense + keyword) using LanceDB, Pinecone, or Elasticsearch. * Define system workflows for summarization, query routing, retrieval, and response generation, ensuring minimal latency and high precision. * Develop RAG evaluation frameworks combining retrieval precision/recall, hallucination detection, and latency metrics — aligned with analyst and business use cases. AI Model Integration & Fine-Tuning * Integrate GPT-4o, PaLM 2, and open-weight models (LLaMA, Mistral) for task-specific contextual Q&A. * Fine-tune transformer models (BERT, SentenceTransformers) for document classification, summarization, and sentiment analysis. * Manage prompt routing and variant testing using Promptfoo or equivalent tools. Agentic AI & Orchestration * Implement multi-agent architectures with modular flows — enabling task-specific agents for summarization, retrieval, classification, and reasoning. * Design fallback and recovery behaviors to ensure robustness in production. * Employ LangGraph for parallel and stateful agent orchestration, error recovery, and deterministic flow control. Data Engineering & RAG Infrastructure * Architect ingestion pipelines for structured and unstructured data — including financial statements, filings, and PDF documents. * Leverage MongoDB for metadata storage and Redis Streams for async task execution and caching. * Implement vector-based search and retrieval layers for high-throughput and low-latency AI systems. Observability & Production Deployment * Deploy end-to-end AI systems on AWS EKS / Azure Kubernetes Service, integrated with CI/CD pipelines (Azure DevOps). * Build comprehensive monitoring dashboards using OpenTelemetry and Signoz, tracking latency, retrieval precision, and application health. * Enforce testing and regression validation using golden datasets and structured assertion checks for all LLM responses. Cross-functional Collaboration * Collaborate with DevOps, MLOps, and application development teams to integrate AI APIs with React / FastAPI-based user interfaces. * Work with business analysts to translate credit, compliance, and customer-support requirements into actionable AI agent workflows. * Mentor a small team of GenAI developers and data engineers in RAG, embeddings, and orchestration techniques. Qualifications • Experience:, • 5+ years as an AI or ML Engineer Required Skills & Experience * LLMs & GenAI: GPT-4o, PaLM 2, LangGraph, LangChain, Promptfoo, SentenceTransformers * RAG Frameworks: LanceDB, Pinecone, ElasticSearch, FAISS, MongoDB * Agentic AI: LangGraph multi-agent orchestration, routing logic, task decomposition * Fine-Tuning: BERT / domain-specific transformer tuning, evaluation framework design * Infra & MLOps: FastAPI, Docker, Kubernetes (EKS/AKS), Redis Streams, Azure DevOps CI/CD * Monitoring: OpenTelemetry, Signoz, Prometheus * Languages & Tools: Python, SQL, REST APIs, Git, Pandas, NumPy * Nice-to-Have Skills * Knowledge of Reranker-based retrieval (MiniLM / CrossEncoder) * Familiarity with Prompt evaluation and scoring (BLEU, ROUGE, Faithfulness) * Domain exposure to Credit Risk, Banking, and Investment Analytics * Experience with RAG benchmark automation and model evaluation dashboards Additional Information

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 Description Role Overview: The Regional Nursing Lead will contribute to the company’s quality and growth by training and coaching Infusion Nurses in their region on clinical topics. This role will also ensure ongoing competency proficiency and answer clinical questions from nurses in the Region. The Regional Nursing Lead will make sure our patients receive the highest level of care possible in infusion therapy by ensuring clinical staff are trained and re-trained appropriately. Location: Remote, with ~50% travel to centers for training and coaching Job Description: * Train new Infusion Nurse hires on-site, providing feedback where necessary * Drive ongoing clinical effectiveness through competency validation, clinical quality measurement, coaching, and feedback * Identify additional training needs across the Region and pilot new initiatives * Serve as initial point of contact for clinical questions from others in Region * Provide clinical care, as necessary Key Qualifications: * Current RN licensure in all states within Region (or ability to gain licensure in all states) * 3+ years of infusion nursing experience and expert infusion clinical knowledge (or strong internal performance that indicates this level of experience) * Ability to travel up to 50% of the time for hands on training and re-training of nurses As part of our team, full-time team members get: * Medical, dental, and vision insurance through our employer plan * Short and long-term disability coverage, life insurance * 401(k) — as an early stage startup, and we match! * 15 Days PTO — and we want you to take it! * Competitive paid parental leave and flexible return to work policy. * We invest in your career. Our company is growing quickly, and we'll give you the opportunity to do the same. You'll have access to a number of professional development opportunities so that you can keep up with the company's evolving needs and grow your career along the way. We don’t discriminate—Local Infusion is an Equal Employment Opportunity (EEO) Employer. We fundamentally believe that a more diverse and inclusive team leads to a stronger company more able to achieve our vision. Join our dynamic team and make a difference in the lives of patients by leading the successful operation of our regional infusion centers. Apply today to be considered for the role of Regional Nursing Lead.

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

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

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

Job Description Company Overview: NRS is a leading provider of transportation & supply chain management services, and a family-owned and operated company that has been providing smart logistics solutions for the world's leading retailers and manufacturers for 70+ years. Whether it’s NRT, Keystone, Keystone Fresh, or Keystone Capacity, our innovative energy drives us towards new and valuable solutions for our clients, even as we continuously grow and strengthen our network. We are dedicated to creating a culture that empowers the individual and offers our associates the opportunity to apply their unique skill to the challenges facing our clients. In the office, the warehouse, or on the road, it is this commitment to our innovative spirit that unites us in common mission to push boundaries in the logistics industry. Join our team at NRS, Inc. and contribute to our mission of providing exceptional transportation and logistics services. We offer a competitive salary and benefits package, and we are committed to providing our employees with a positive work environment and opportunities for growth and development. Apply now and be a part of our success story! This role is onsite and based in Lyndhurst, NJ. Job Overview: As a member of the Full Stack Development team within the Information Technology organization, the Application Developer II works closely with leading experts on our IT teams and across our business units to define, develop, maintain, modify, and support custom software solutions. This role plays a crucial part in ensuring our customers’ needs are met through the deployment and updates of business-critical solutions. Duties & Responsibilities: Leadership & Communication • Support and promote the company values, culture, and HR processes, • Analyze customer requirements to determine feasibility of design within time and cost constraints, • Consult with internal staff and external vendors to evaluate overall system performance and proactively identify areas for improvement, • Participate in project activities, providing status updates, resource estimates, and guidance on software solution scope and requirements, • Document all aspects of the software solution for future upgrades and maintenance, • Learn and apply NRS’s established standards for technology, tools, and techniques, • Maintain and improve existing codebases; peer-review code changes, • Provide solution support for escalated issues across all stages of the SDLC, • Use experience and industry knowledge to propose and evaluate new technologies that align with current and future business needs, • Build trust and strong working relationships with Technology and Business stakeholders, • Bachelor’s degree in Computer Science or related field, or equivalent practical experience, • Strong problem-solving skills and attention to detail, • Excellent organizational, interpersonal, and communication skills, • Strong business acumen and ability to adapt to change, • Continuous Learning — staying updated with emerging integration technologies and techniques • Back-end Engineering (Java + Spring Boot): 4–8 years – Production experience with Java 17/21 and Spring Boot 3+, building and maintaining REST/SOAP services; JSON/XML, pagination, versioning, concurrency, robust error handling. • API Integrations: 3+ years – End-to-end integrations via webhooks and polling; schema/data mapping and validation; file-based flows (CSV/XML/JSON over SFTP) when APIs aren’t available; translating vendor specs into production solutions. • Authentication & Security: 2+ years – OAuth2/OIDC, API Keys/HMAC, mTLS; input validation and audit logging; secrets and IAM hygiene with least-privilege access. • AWS Integration Stack: 2–4+ years – Hands-on with API Gateway (incl. VPC Link), Lambda or ECS/Fargate workers, SQS/SNS/EventBridge, Step Functions, Secrets Manager, CloudWatch/X-Ray; private connectivity to on‑prem/partner systems. • Data Layer & Performance: 3+ years – SQL (Postgres/MySQL/DB2), JDBC/JPA, query tuning and indexing, transaction boundaries; caching (Redis) and reliability patterns (outbox, idempotency, DLQ). • CI/CD & Quality: 3+ years – Git workflows and code reviews; JUnit 5/Mockito; Maven/Gradle; pipelines (Jenkins/GitHub Actions); safe deploys (blue/green or canary). • Stakeholder & Vendor Collaboration: 2+ years – Author mapping docs, test plans, and UAT scripts; clear communication with business partners and third-party vendors. Preferred / Nice to Have • IBM i (AS/400): DB2 for i via JDBC/ODBC, JT400, calling RPG programs, SFTP flat-file exchanges — 1+ year, • This position may require travel to various company locations on the East and West Coast, • Extended sitting: primarily desk-based with prolonged computer use, • Computer use: frequent operation of computers and office equipment, requiring manual dexterity, • Eye strain and repetitive motion: risk from continuous screen use and repetitive tasks like typing, • Office navigation: light walking and standing for meetings and tasks within the office NRS is an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #NRSIND

Job DescriptionSalary: 65,000-80,000 Essential Duties and Responsibilities The below statements are intended to describe the general nature and scope of work being performed by this position. This is not a complete listing of all responsibilities, duties and/or skills required. Other duties may be assigned. Compliance and Records Management • Plans development and implementation of legal records management policies intended to standardize the filing, protecting, and retrieval of records, reports, and other paper-based and/or electronic information, ensuring that records are classified, maintained, retained, and destroyed in accordance with policies as established by the New Jersey State Archives Bureau., • Ensures that effective and efficient storing, arranging, indexing, classifying, inventory, retention, and legal records disposal systems are established that meet administrative, legal, and financial requirements., • Utilizes knowledge of principles of records and information management, administrative processes and systems, cost control, governmental recordkeeping requirements, and organizational objectives; coordinates and directs activities of other departments involved with records management analysis, reports analysis, cataloging, inventory, retention, and destruction of records; and confers with those departments to assure compliance with policies, procedures, and practices of records management., • Identifies the most appropriate records management resources needed to establish and maintain legal filing and classification systems., • Schedules and participates in training seminars and sessions designed to provide a policy framework for the management of legal records., • Resolves problems with legal information management through effective use of software and other information management resources., • Enables appropriate access to information within the Legal Department., • Responds to internal and/or external inquiries for legal information, including formal requests to access Public Records pursuant to the Open Public Records Act (OPRA)., • Monitor and assess adherence to policies and recommend improvements to governance practices. Property and Casualty Insurance Management • Conducts, oversees, and arranges a full range of appraisal inspections and inventories, including financial and operating data, and establishes information which serves as a basis for identifying assets, liability, and determining extent of coverage and premiums., • Advises management on all matters related to loss amounts and types of insurance needed to provide proper coverage and reserves in case of loss., • Recommends the selection of insurance brokers and carries out alternate methods of insurance by analyzing/comparing coverage, premiums, policy terms, and other provisions; and arranges for adequate insurance protection for assets of the jurisdiction., • Purchases casualty and property insurance coverage by developing invitations-for-bid and requests for proposal or quotations; facilitates the selection of the most economical source of insurance protection; and coordinates and arranges the implementation of various insurance programs., • Arranges bonding and insurance of public property and personnel., • Examines leases, contracts, and rental agreements for liability clauses included in insurance policy., • Appraises value of government properties to determine appropriate insurance policy and coverage., • Arranges special public institutional property insurance coverage after determining if institutions are eligible for coverage., • Maintains claim procedures for use in claim investigations., • Aids Legal Department in negotiations with government entity as lessor or lessee by determining contract liability contained in leases and liability insurance coverage., • Arranges for bonding of public employees by researching statutes, setting up terms of bond, and contracts with bonding companies., • Collects information and materials required for review, evaluation, and analysis by insurance consultants and insurance fund commission., • Coordinates processing of claims against the policies held by the jurisdiction., • Acts as liaison between the claimants, insurance administrators and the jurisdiction., • Processes and checks claim forms filed with the insurance administrator in connection with the entitys self insured fund., • Maintains records of policies, premiums, losses, recoveries, types of contracts and expiration dates. Notices of Claim Processing • Oversees and administers all aspects of claims intake, investigation, processing, and resolution, ensuring efficiency, compliance, and quality throughout the claims lifecycle., • Conducts claims intake & processing, as well as oversees the receipt, review, validation, and adjudication of claims submissions, ensuring accuracy and compliance with policy and regulatory requirements., • Conducts evaluation and investigation of claims, collaborate with internal teams and external parties, and determine liability or coverage., • Ensure all claims are handled in accordance with NHAs procedures and relevant legal/regulatory standards, performing regular audits and risk assessments., • Prepare and analyze claims data, identify trends, generate reports, and provide recommendations for process improvements and loss reduction. Office Management and Administrative Support • Assists in supervising the business operations of the Legal Department, including: financial and personnel records; purchase, receipt, and issuing of equipment, materials, and supplies; and collection, analysis, and interpretation of data pertaining to collections, expenditures, budgets, stores, and other operational procedures., • Serves as liaison with other departments and agencies to alleviate management and administrative problems and fulfill organizational needs and requirements., • Monitors and reviews legislation and regulations affecting the needs and interest of the jurisdiction, and analyzes the impact of legislation and regulations on the jurisdiction., • Receives, reviews, and addresses complaints from constituents; participates in or performs special studies or investigations involving constituent complaints which require the review of information in highly sensitive areas; and makes recommendations regarding appropriate action(s)., • Confers with the Chief Legal Officer concerning workload and/or emergency periods., • Prepares monthly, annual and other reports., • Carries out administrative assignments received from the Chief Legal Officer., • Performs other related duties as requested. Job Competencies • Risk Management Strong understanding of enterprise risk principles, property/casualty coverage, loss prevention, and claims handling including processing and investigating notices of claims., • Compliance & Governance Knowledge of state and federal regulatory frameworks affecting public housing operations., • Analytical Thinking Ability to assess financial, operational, and legal risk factors using qualitative and quantitative methods., • Communication Ability to clearly communicate findings, risks, and recommendations to executives, department heads, and external partners., • Decision-Making Strong judgment in developing and implementing risk mitigation strategies., • Extensive knowledge of the principles of archival, records and information management principles and practices, records retention and disposition., • Ability to create and implement standard operating procedures for archival collection, storage and protection., • Practical knowledge of legislation governing information and records (OPRA, etc.)., • Experience in monitoring and assessing compliance in the area of records retention., • Experience in quality control operations/activities., • Extensive knowledge of property and casualty insurance principles and practices, as well as Federal, State and Local regulations and programs regarding property and casualty insurance., • Experience analyzing internal office workflow and establishing procedures to improve effectiveness and efficiency of operations. Education and/or Experience Bachelor's degree from an accredited college or university, with at least five (5) years of professional experience in the administration of a comprehensive workplace standards and enforcement program, professional experience in risk management, insurance administration, compliance, or operations analysis, including supervisory or project leadership responsibilities. Experience with property and casualty insurance, claims management, bonding procedures, and risk analysis in a government or housing authority or public entity setting strongly preferred. Proficiency in Microsoft Office Suite (Excel, Word) and risk/records management systems.

Job Description Electrical, Controls Engineer - Industrial Electro-Mechanical Machinery Industry Focus: Industrial Machinery I Electromechanical Equipment I Custom Automation Systems Robotics I Industrial Controls I Food and Beverage Manufacturing I Packaging Equipment I Water and Wastewater Treatment I Process Equipment I OEM Machine Building We are currently seeking to identify (2) Electrical Controls Engineers to join a well-established and growing industrial equipment manufacturer with over 50 years of engineering excellence. One opportunity is ideal for a junior to mid-level candidate with at least 2+ years of relevant experience, and the other is targeted for a senior-level engineer with more years of hands-on experience in electrical design, programming, controls, and industrial automation. This is your chance to join a team that builds large-scale electromechanical systems from concept through completion. From food production lines to custom process and water treatment equipment, you'll be working on machinery that makes a real-world impact. Responsibilities: · Design, develop, and program industrial electrical control systems to meet engineering and client requirements · Create electrical schematics, wiring diagrams, and panel layouts using AutoCAD Electrical or similar design software · Specify, select, and configure control system components such as PLCs, VFDs, relays, sensors, and breakers · Program PLCs and HMIs (Allen-Bradley, Siemens, or similar platforms preferred) · Layout and design control panels and motor control centers (MCCs) · Perform validation testing and troubleshoot electrical systems during build and final assembly · Collaborate closely with mechanical engineers, software engineers, and production teams to ensure full integration · Provide technical documentation including BOMs, manuals, wiring lists, and startup procedures · Travel as needed for commissioning and system validation (minimal and planned in advance) · Stay current with evolving industry technology, best practices, and safety standards Qualifications: We are hiring for two experience levels. Candidates must meet the criteria for one of the following profiles: Junior to Mid-Level Role: · Minimum 2 years of experience in electrical controls, panel design, or related engineering environment · Experience with AutoCAD Electrical or similar drafting tools · Working knowledge of industrial components and safety regulations · Basic PLC programming knowledge or exposure to automation software · Strong interest in hands-on engineering, testing, and troubleshooting · Bachelor's degree in Electrical Engineering or equivalent hands-on experience Senior-Level Role: · Experience in electrical controls and industrial automation · Proficiency in AutoCAD Electrical and strong PLC/HMI programming experience · Deep understanding of UL, NEC, NFPA 70E, and electrical safety standards · Demonstrated success leading projects or contributing to complex custom machinery builds · Ability to mentor junior team members and drive design improvements · Background in electromechanical system design and manufacturing support What Makes This Opportunity Unique: · Privately owned and financially strong company with over 50 years of proven success · All engineering and manufacturing is done in-house at our US-based facilities · Recession-resistant with projects in food processing, water treatment, packaging, and more · Work directly on high-impact custom systems from design to completion · Short lead times and an integrated design-build process · Access to a seasoned engineering team for mentorship and collaboration · Competitive salary structure with performance bonuses · Opportunities for growth into technical leadership or project management · Continued access to learning and development in electrical, automation, and mechanical engineering · Team-focused culture that values practical problem-solving, quality, and innovation Traits That Set You Up for Success: · Detail-oriented and self-driven with a strong sense of accountability · Hands-on mindset and curiosity to understand how systems work · Enjoy working on one-off and custom systems that challenge your engineering creativity · Collaborative and open communicator, ready to share and receive feedback · Willing to dive into troubleshooting and help bring machines across the finish line · Honest, reliable, and committed to continuous improvement Take the Next Step in Your Career: If you are passionate about industrial electrical systems and automation, whether you are building your skills or bringing a wealth of experience, we want to hear from you. These roles offer the chance to work on meaningful projects with a stable, growing company where your contributions matter every day. Apply now to explore how you can be a part of building the next generation of industrial automation and electromechanical systems. Equal Opportunity Commitment: We and our client are equal opportunity employers and welcome all qualified applicants regardless of race, religion, gender, age, disability, veteran status, or any other protected classification.

Job Description Senior Mechanical Engineer Electromechanical Systems and Industrial Machinery Employment Type: Full-Time Industry Focus: Electromechanical Equipment I Automation Systems I Industrial Manufacturing I Robotics I Custom Machinery I Food and Beverage I Packaging I Water and Wastewater I Processing Equipment A privately owned, highly respected manufacturer with over 50+ years of success delivering complex, high-quality custom and benchmark electromechanical systems for critical infrastructure. Seeking to add to our engineering team a seasoned professional to help us build custom machinery used across the food and beverage, water treatment, packaging, energy, and automation sectors. Every system is designed, fabricated, and assembled on-site in their U.S.-based facilities. A financially stable, customer-trusted, and operates with speed, precision, and integrity. With low turnover, strong leadership, and a tight-knit, collaborative team, this is a rare opportunity for a senior-level engineer looking to make a real impact. Why Work Here • A privately-owned, financially secure, stable organization with a bold growth plan, your contributions matter here, • Recession-resistant with a strong, diverse client base, • All manufacturing and engineering done on-site in the U.S., • Short lead times and fully integrated workflow, • Diverse vertical markets including food processing, automated packaging, and industrial systems, • Long-tenured team with low turnover and deep technical experience, • Real mentorship from senior engineers and technical leadership, • A collaborative, team-first culture that values craftsmanship, integrity, and innovation, • Competitive salary + performance-based bonuses, • Clear pathways for career advancement into operations, technical leadership, or project management, • Access to ongoing technical training and development resources, • Opportunities to work on meaningful projects that impact essential industries, • Flexibility, autonomy, and a culture where good ideas get traction What You Will Do • Lead the design and development of mechanical and electromechanical systems, • Engineer custom industrial machinery, motion systems, and integration for real-world automation, • Create detailed 3D CAD models and drawings using Autodesk Inventor, SolidWorks, and AutoCAD, • Play a key role in the transition to Autodesk Inventor as the core design platform, • Collaborate with sales, drafting, production, service, and R&D teams to ensure design feasibility and performance, • Attend Factory Acceptance Tests, system demos, and customer meetings, • Conduct hands-on testing and root cause analysis to solve engineering challenges, • Recommend improvements to enhance reliability, manufacturability, and cost-efficiency, • Generate full technical documentation including BOMs, manuals, and assembly instructions, • Provide limited on-site support for commissioning and validation, travel is minimal (0 to 2 percent) What You Bring to the Role • Experience designing electromechanical equipment, custom machinery, and automated systems, • High-level proficiency in Autodesk Inventor preferred, along with SolidWorks and AutoCAD, • Solid understanding of GD&T, tolerance analysis, mechanical fasteners, motion control, and pneumatics, • Familiarity with PLM systems and NPI workflows, • Hands-on background and mechanical aptitude is strongly valued. Candidates who enjoy working on cars, engines, machines, or DIY projects often excel here, • Strong communication and collaboration skills with the ability to present technical information clearly to both internal teams and clients, • Associate or bachelor’s degree in Mechanical Engineering or a related discipline, or equivalent hands-on experience, • Proficiency in Microsoft Office and collaboration tools like SharePoint and Microsoft Teams Nice to Have ~But Not Required While not required, familiarity with the following codes and standards is considered a plus: • ASME Section VIII for pressure vessel design and inspection, • ASME B31.1 and B31.3 for power and process piping, • ASME Y14.5 for geometric dimensioning and tolerancing, • ASME B16.5, B36.10M for flanges, pipes, and fittings, • ASME PTC 4 and PTC 46 for boiler and plant performance testing Traits That Help Engineers Thrive Here • Curiosity and a hands-on mindset, • Creative approach to solving practical engineering problems, • Ability to see the big picture while staying detail-oriented, • Integrity, loyalty, and a team-first attitude, • Enjoys challenging workflow, with fresh projects, • Adaptability in a fast-paced manufacturing environment Let’s Build What’s Next – Together If you’re driven by precision, purpose, and the challenge of making great ideas real, we’d love to hear from you. Looking forward getting to know you… We are as well as our client are an equal opportunity employer and welcome all qualified applicants regardless of race, gender, age, disability, veteran status, or other protected classification.

Job Description Providing Engineering and Manufacturing solutions since 1955, Triangle specializes in the 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 Responsible for the successful outcome of the development and implementation of the complete part-specific process by effectively translating the customer’s requirements to the company and suppliers, and adhering to the Quality Management System, all applicable regulations, and Lean Manufacturing principles. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. • Manages all aspects of the part-specific process, including resource planning, project timelines, and establishing priorities to ensure customer requirements and quoted standards are met., • Evaluates and improves process documentation protocols for engineering and manufacturing, as well as creates, updates, and maintains the item masters, bills of material, and routers, etc., • Reviews requests for quotes (RFQs) and helps determine the feasibility of projects, estimates labor and related costs, and prepares formal quotes for submission to customers., • Teams with customers to review designs for manufacturability and to understand the functionality of the part and its features, adds specifications as needed, and verifies GD&T was properly applied., • Clarifies, confirms, and correlates acceptance criteria with customers, company, and suppliers., • Develops manufacturing methods for new and existing projects by reviewing customer specifications and quality agreements, adhering to all applicable requirements, and effectively translating them into instructions., • Performs initial sourcing and qualifies suppliers from a technical perspective, as well as effectively communicates the customer requirements through training and auditing of the supplier’s performance on a regular basis., • Ensures product quality through the development and implementation of complete quality plans including CMM programming, gage design and procurement, and inspection plans., • Coordinates and/or performs validation activities (IQ, OQ, PQ) designed to qualify the equipment and the process as required., • Teams with the CNC Engineer to design work-holding devices and tooling as needed to ensure the desired outcome., • Investigates root cause of customer and/or supplier rejections and internal quality failures, dispositions non-conforming parts, recommends and implements effective corrective action as required, and provides accurate and timely responses to customers., • Determines the impact of ECNs on bills of material, routing, and spares, and coordinates any change., • Leads the post-production review and evaluation of the part-specific process, including equipment performance and product quality, recommends improvements, and coordinates their implementation., • Provides direction and on-the-job training to engineering and production associates regarding manufacturing methods and practices, as well as recommends, develops, and implements complete training programs, including materials and assessments., • Champions lean manufacturing principles by encouraging lean thinking in all aspects of development and production, as well as conducting and/or coordinating training and implementation with managers and associates., • Understands and complies with company policies, safety guidelines, quality system procedures, and housekeeping standards.Additional Duties and Responsibilities:, • Program, troubleshoot, and manage the Universal Robots arms., • Oversee the fixture designs, programs, prove outs, operation, and maintenance of the automated blasters., • Identify opportunities for automation within the organization and develop solutions to enhance productivity., • Collaborate with various departments to implement automation projects., • Ensure all automated systems comply with safety and quality standards., • Provide training and support to staff on the use of automated equipment. 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 Manufacturing Engineer Certification and 8-10 years related experience and/or training; or equivalent combination of education and experience. Required Skills, Knowledge, and Abilities: • Ability to read, write, and speak English. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, customers, and the general public., • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations., • Experience with computer applications, including word-processing, spreadsheets, graphs, databases, CAD, and presentations., • Experience with process capability, Gage R&R, and statistical techniques., • Experience in using basic and advanced measuring tools and equipment., • Applied knowledge of Geometric Dimensioning & Tolerancing (GD&T)., • Capable of working independently as well as collaborating and coordinating efforts with colleagues., • Ability to establish priorities and manage multiple activities and requirements in a changing, fast-paced environment., • Experience with manufacturing materials, manufacturing processes, and secondary processes., • Project management skills.Desired Skills, Knowledge, and Abilities:, • Advanced metrology (CMM programming, vision system, etc.)., • Lean/Six Sigma. 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 QvoSIKq1TI

Job DescriptionCompany Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is safer and more secure than the one before. We are a company built on the foundation of challenging and disrupting the way things are done, and we’re looking for innovators who are as committed to shaping the future of cybersecurity as we are. Who We Are We believe collaboration thrives in person. That’s why most of our teams work from the office full time, with flexibility when it’s needed. This model supports real-time problem-solving, stronger relationships, and the kind of precision that drives great outcomes. Job Description Your Career The Solutions Consultant Manager is the evolution of the traditional Sales Engineer Manager role, aligning how we lead teams to best serve our customers in understanding their environment, providing solution guidance and ensuring value realization in their investment with Palo Alto Networks. As our Solutions Consultant Manager, you are the technical leader for your District Solutions Consulting team. You will work closely with the District Sales Manager and, along with your team, build relationships with your customers with the goal of helping them detect and prevent advanced cyberattacks and breaches. Our customers need guidance on what applications to deploy from our platform. Your guidance, expertise, and mentorship of your team will keep them ahead of the latest cyberthreats and stay on the leading edge of prevention. As the technical leader for your assigned territory, you will guide and develop your team to define innovative technical solutions that secure customers' key business imperatives and maximize the value of their investment with Palo Alto Networks. You will champion our industry leadership in on-premises, cloud, and security operations services, establishing Palo Alto Networks as the preferred cybersecurity partner for your customers. You will also nurture talent within your team and provide valuable feedback to the product management team on new feature requests and product improvements based on insights gained from your customer interaction. Your team will play a key role in defining technical solutions that secure a customer’s key business imperatives and ensuring value realization of their investment with Palo Alto Networks. Your Impact * Recruit and hire new Solutions Consultants into the territory, hiring the best talent in the industry * Responsible for training, mentoring, and reviewing employees on your team, keeping them engaged and successful in their careers * Support field Solutions Consultant team in complex evaluations, problem-solving and challenging customer environments * Leads and coaches team on successful technical validation efforts based on best practices to ensure technical win in assigned opportunities. * Define, create and monitor individual development plans for your team * Works closely with Professional Services, Customer Success and Specialist teams to ensure overall customer implementation and adoption of solutions. * Provide effective technical leadership in customer interactions to include sharing security trends and standard methodologies employed by other customers to actively be part of the selling process * Drive Palo Alto Networks Platformization efforts within your accounts. * Work closely with the Domain Specialist Manager to ensure optimal use of resources and align the required resources to the projects you are handling * Act as an escalation point to collaborate with pre-sales and post-sales teams for any issues that arise * Build and maintain relationships with key customers to solidify reference accounts and to assist the account teams with defining plans to drive more business * Present to customers as our expert in your area at all levels in the customer hierarchy from technician to CIO * Discuss competitor products in the marketplace and positions ours as the best alternative * Working with Product Management, Technical Marketing, and R&D to build requirements and product features for our large customers and provide feedback from customers * 50-75% travel within the region * Work with your sales counterpart (DSM) to develop a technical strategy that accelerates growth. Identify key verticals, markets, use cases, and solutions to focus on, and devise a comprehensive strategy and engagement model tailored to your region or district. Qualifications Your Experience * Experience as a pre-sales System Engineer Manager * Experience as a Senior System Engineer/Specialist * Industry knowledge of security product market trends and directional awareness of our roadmap and technology development efforts, knowledge of competitor offerings and products * Knowledge of how to deliver comprehensive security solutions to Palo Alto Networks customer base * Experience in selling, designing, implementing or managing one or more of the following solutions: Network Security, SASE, SaaS, CNAPP and/or SOC Transformation Technologies * Partnering with Customer Support functions to ensure successful implementation and adoption of sold solutions * Strong communication (written and verbal) and presentation skills * Quota driven attitude focused on client's best solution by being a trusted advisor * Proficient in English Additional Information The Team Our Solutions Consultant team members work hand-in-hand with large organizations around the world to keep their digital environments protected. We educate, inspire, and empower our potential clients in their journey to security. You are empowered with unmatched systems and tools and a team built on joint success. You won’t find someone at Palo Alto Networks that isn’t committed to your success – with everyone pitching in to assist when it comes to solutions selling, learning, and development. Our Solutions Consulting community is driven by the mission to be our customers’ cybersecurity partner of choice, protecting their digital way of life. Compensation Disclosure The compensation offered for this position will depend on qualifications, experience, and work location. For candidates who receive an offer at the posted level, the starting base salary (for non-sales roles) or base salary + commission target (for sales/commissioned roles) is expected to be between $224000 - $308000/YR. The offered compensation may also include restricted stock units and a bonus. A description of our employee benefits may be found here. Our Commitment We’re problem solvers that take risks and challenge cybersecurity’s status quo. It’s simple: we can’t accomplish our mission without diverse teams innovating, together. We are committed to providing reasonable accommodations for all qualified individuals with a disability. If you require assistance or accommodation due to a disability or special need, please contact us at . Palo Alto Networks is an equal opportunity employer. We celebrate diversity in our workplace, and all qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or other legally protected characteristics. All your information will be kept confidential according to EEO guidelines.

Job DescriptionLocation: Hackensack, NJ Employment Type: Full-time About the Role: We are seeking a detail-oriented and motivated QA Coordinatorto join our team. The ideal candidate will be responsible for creating, documenting, and executing system test plans and test scripts, as well as validating data and analyzing test results. This role involves identifying, reporting, and tracking software issues, and communicating findings and progress updates with our software development team in Korea. Key Responsibilities: * Develop, document, and execute comprehensive system test plans and test scripts. * Perform data validation and analyze test results to ensure software quality. * Record, report, track, and retest bugs found during testing. * Collaborate and communicate effectively with software developers in Korea to resolve issues. * Support continuous improvement of testing processes and documentation. Qualifications: * Bachelor’s degree in Computer Science or a related field. * Bilingual proficiency in Korean and English (both written and verbal). * 1–2 years of experience in system testing of Windows-based Point of Sales (POS) software. * Hands-on experience with PC POS peripherals such as printers, barcode scanners, customer displays (CDP), and dot matrix printers. * Strong analytical, problem-solving, and communication skills. * High attention to detail and ability to work in a fast-paced environment. Benefits: Group Health Insurance (Medical, Dental, Vision) Employer paid Life Insurance Paid Sick and Vacation 401K with 3% matching Gym Reimbursement Company Lunch Please visit our website for more information

Key Responsibilities Conduct comprehensive validations of model components to ensure accuracy and regulatory compliance Evaluate model frameworks, including design, variable selection, and testing procedures Produce validation reports and assist in audit and regulatory review support Required Q

POSITION SUMMARY: Looking for candidates at Chemist I, II and III levels responsible for carrying out analytical method validation/verification activities and testing for Oral Solids, Oral Liquids, Topicals and Powders. MAJOR DUTIES/RESPONSIBILITIES: • Develop/Validate/Verify analytical (HPLC, GC, ICP-MS/OES, other) methods for assay and impurities determination in drug substances and drug products., • Perform wet chemistry and chromatographic testing for raw materials and products under development phase, • Perform stability studies for drug products in development phase and generate reports, • Develop and validate cleaning methods and generated study protocols and reports, • Prepare relevant protocols, reports, and final methods, • Maintain proper instrument calibration status, • Ensure that work is carried out safely and in compliance with the organization’s quality system, • Ensure that quality documentation is generated and updated to reflect current best practice in a timely manner., • Perform peer review at Chemist III level, not required if you’re applying for Chemist I/II levels., • Perform other duties as assigned. MINIMUM/PREFERRED REQUIREMENTS: Education: Bachelor or Master’s degree in science or Pharmaceutics. Experience: Bachelor’s with 2-7 years of experience in a generic pharmaceutical analytical lab. Master’s is preferred. Candidates shall be considered for different positions based on educational qualification and experience. Good understanding of cGMPs is a must for experienced candidates. PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS: • Laboratory and office environment, • Able to lift about 25 pounds., • Able to stand and or sit for longer period of time. On-site, Full-time, Day Shift

Company Description Stira Pharmaceuticals is a sterile injectable CDMO specializing in small molecules and peptides, with deep expertise in pharmaceutical product development and manufacturing. Our team of skilled scientists leverages proprietary technology platforms and extensive industry experience to develop innovative solutions for challenging products. We provide a comprehensive range of services, including Analytical R&D, Formulation Development, Stability Testing, Microbiology, Regulatory Support, and more. At Stira, we are committed to delivering high-quality, reliable solutions that meet the evolving needs of our global clients. Role Description This is a full-time, on-site Director of Business Development role based in Fairfield, NJ. The selected candidate will lead and expand business development initiatives for Stira Pharmaceuticals’ sterile Contract Development & Manufacturing Organization (CDMO) and Analytical Services. You will be responsible for identifying and acquiring new business opportunities, creating and executing strategic business plans, generating leads, managing key accounts, negotiating contracts, and fostering long-term client relationships. Close collaboration with internal teams to align business goals with client needs is a critical part of this role. Key Responsibilities • Develop and execute business development strategies to grow the sterile CDMO and analytical services business., • Identify, engage, and acquire new clients for development, tech transfer, analytical testing, and manufacturing programs., • Lead proposal development, pricing strategy, contract negotiation, and deal closure., • Build and maintain a strong pipeline of opportunities across peptides, long-acting injectables, ophthalmic products, small-molecule injectables, and other complex formulations., • Represent Stira at conferences, client meetings, and industry events to promote capabilities and generate leads., • Collaborate with internal cross-functional teams (R&D, Analytical, QC, Manufacturing, Regulatory) to develop tailored client solutions., • Understand client program requirements and translate them into actionable scopes of work., • Monitor industry trends, competitor activities, and market dynamics to support strategic decisions., • Maintain CRM tracking, forecasting, reporting, and KPI management to support executive leadership., • Support the creation and refinement of marketing materials, capability decks, and external communications. Qualifications • Bachelor’s or Master’s degree in Life Sciences, Chemistry, Pharmacy, or a related field; advanced degree preferred., • 10+ years of experience in business development within a sterile injectable CDMO, pharma outsourcing, or analytical services environment., • Strong knowledge of sterile manufacturing processes, analytical method development/validation, and CMC workflows., • Proven track record in securing new business, managing client accounts, and achieving revenue targets., • Excellent communication, negotiation, and relationship-building skills., • Ability to work independently in a fast-paced, growing organization., • Willingness to travel for client visits and industry events. How to Apply Interested candidates may submit their resume and a brief cover letter via LinkedIn or email • with the subject line: Director, Business Development Application.

A company is looking for a Business Planning & Data Operations PM.Key Responsibilities Develop and implement SQL data pipeline setup plans and maintain dashboards for actionable insights Execute launch data validation checklists and manage system updates for new product introductions Coordinate