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INTERNAL CONTROLS OFFICER SENIOR WHAT IS THE OPPORTUNITY?Internal Controls Officer is responsible for providing independent and objective oversight of the management of risks arising from City National Bank's business processes, people, systems or external events. The team is responsible for providing governance and oversight to enhance the control environment to ensure successful remediation of operational risk exposures. This includes providing practical guidance, functional expertise, strategic direction, and execution rigor to significant operational risk remediation activities. The Senior Officer is responsible for challenging the quality, sufficiency, and completeness of 1LOD risk remediation and control management activities for moderate to high-risk initiatives in compliance with the Issue Management Policy and Standard and the Internal Controls Management Policy (ICMP) and Standard and for communication outcomes of objective assessment through escalation and reporting to Senior Management as necessary. WHAT WILL YOU DO? • Conduct review and challenge of remediation initiatives to ensure operational risk exposures associated with known control deficiencies are addressed. This includes providing challenge throughout the Issue Management Lifecycle, which may include issue data details; root cause analysis; action plan; material issue changes; management's completion of the required and/or committed corrective actions with supporting evidence; and sustainability., • Conduct review and challenge of controls implemented. This includes providing feedback to risk and control owners and control assessment teams related to the following control management activities: control identification to match appropriate controls with identified risk exposures to lower the residual risk level; completeness and robustness of control documentation; reasonableness of control assessment approach and sample selection; consistency of design effectiveness and operating effectiveness conclusions with supporting evidence; and appropriateness of documented issues and action plans to remediate identified control failure., • Ensures work is produced and documented in alignment with quality and content requirements., • Provides clear and transparent updates on remediation progress, • Exercises independent judgment in identifying and assessing risk., • Prepares, reviews, and presents review and challenge results to Leadership, including outlining the risk of control deficiencies, • Ensures observations and findings are documented and escalated to appropriate leadership., • Exercises effective communication and promotes positive client relations with business line colleagues and management, • Maintains authoritative knowledge and understanding of laws and regulations, regulatory guidance, policy, and procedures for operational functions covered., • Provides 2LOD audit and regulatory exam support., • Executes additional departmental initiatives and other duties as assigned. WHAT DO YOU NEED TO SUCCEED?Required Qualifications* • Bachelor's Degree or equivalent, • Minimum 7 years of experience in financial services industry, with at least five years in an operational risk management, internal audit, or compliance role, • Minimum 3 years of control assessment and validation experience, • Minimum 1 year of supervisory experienceAdditional Qualifications, • Bachelor's degree or higher and other professional qualifications such as a CPA, CA, etc., • Strong business knowledge of financial services, • Understanding of Risk Management/Operational Risk Management and Internal Controls testing methodology, • Strong knowledge of issue management practices with proven experience in issue management design and/or execution, • Ability to handle complexity and ambiguity, • Proven track record building strong relationships across multiple business functions, • Ability to deal effectively with conflict, • Well-developed influencing, analytical and problem solving skills, • Must be able to convey complex concepts in a clear and concise manner, • Ability to work independently with effective time and project management, • Ability to work in a matrix environment, • Strong interpersonal/teamwork skills, • Comprehensive healthcare coverage, including Medical, Dental and Vision plans, available the first of the month following start date, • Generous 401(k) company matching contribution, • Career Development through Tuition Reimbursement and other internal upskilling and training resources, • Valued Time Away benefits including vacation, sick and volunteer time, • Specialized health and family planning benefits including fertility benefits, and cancer, diabetes and musculoskeletal support programs, • Career Mobility support from a dedicated recruitment team It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. *Represents basic qualifications for the position. To be considered for this position, you must at least meet the required qualifications. careers.cnb.com accepts applications on an ongoing basis, until filled. Unless otherwise indicated as fully remote, reporting into a designated City National location is an essential function of the job.

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.

SR. AUDIT MANAGER- BSA/AML WHAT IS THE OPPORTUNITY?The Senior Audit Manager will lead a team of auditors to assess the design and operating effectiveness of internal controls, adherence to regulatory requirements and Bank policies, and the effectiveness of operations of the BSA/AML function. The Senior Manager will be responsible for all aspects of the audit, including the planning, execution, and reporting phases. The Senior Manager will also be involved in internal and external issue validation as well as audit continuous monitoring activities; along with Data Analytics to support continuous monitoring, leveraging the use of information analytics, business intelligence, data mining, and other technologies and tools. WHAT WILL YOU DO? • Providing independent and objective evaluation of the adequacy and effectiveness of Anti-Money Laundering (AML) and Office of Foreign Assets Control (OFAC) practices for City National Bank (CNB), • Championing a thorough understanding of the AML and BSA requirements, including but not limited to the Bank Secrecy Act and OFAC regulations, guidance, and regulatory expectations, • Support the Director of Audit AML BSA by helping to lead and execute CNB BSA/AML and OFAC audits, including through the audit planning, execution, reporting, and issue remediation phases., • Assists with the development of audit budget estimates for respective area of focus, • Assists with the development of the annual risk assessment and audit plan, • Leads and performs continuous monitoring activities periodically for the area assigned, • Maintains ongoing relationships with management of auditable units, • Keeps informed of new services, products and events that have a significant business and technology impact, • Keeps abreast of changes in the business, regulatory, and control environments in which City National Bank operates, especially for audit areas assigned, • Tracks and manages audit resources to meet the audit budget and audit plan mandates, • Supports a high-performance environment and implements a people strategy that attracts, retains, develops and motivates the team for continuous learning and improvement by fostering an inclusive work environment, communicating vison/ strategy, coaching, and supporting development goals., • Complies fully with all Bank policies and procedures as well as all regulatory requirements (e.g. Bank Secrecy Act, Know Your Client, Community Reinvestment Act, Fair Lending Practices, Code of Conduct, etc.). WHAT DO YOU NEED TO SUCCEED?Required Qualifications* • Bachelor's Degree or equivalent, • Minimum 7+ years of audit experience in an internal audit role within the banking or financial services industry, or with an public accounting firm., • Minimum 3 years' experience managing direct reports and demonstrated ability to develop peopleAdditional Qualifications, • CPA or CIA preferred. Other certifications (e.g., CRMA, CFA, CFE, CAMS, Chartered Accountant) are favorable, • A thorough understanding of regulatory and compliance policies and procedures., • Possess expert understanding of internal audit methodology and principles., • Ability to be resourceful, a self -starter, possessing a high degree of flexibility, creative thinking and confidence to carry out innovative solutions., • Well-developed judgment, management, decision-making and problem-solving skills are required in order to effectively deal with a rapidly changing, complex business environment., • Good time management skills in order to manage multi-functional accountabilities through prioritization, delegation, motivation, conflict resolution and the promotion of ideas., • Comprehensive healthcare coverage, including Medical, Dental and Vision plans, available the first of the month following start date, • Generous 401(k) company matching contribution, • Career Development through Tuition Reimbursement and other internal upskilling and training resources, • Valued Time Away benefits including vacation, sick and volunteer time, • Specialized health and family planning benefits including fertility benefits, and cancer, diabetes and musculoskeletal support programs, • Career Mobility support from a dedicated recruitment team It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. *Represents basic qualifications for the position. To be considered for this position, you must at least meet the required qualifications. careers.cnb.com accepts applications on an ongoing basis, until filled. Unless otherwise indicated as fully remote, reporting into a designated City National location is an essential function of the job. #LI-KTB #CA-KTB

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

Key Responsibilities Refine and implement the QA strategy for Engineering teams Establish test automation frameworks to validate correctness, security, and performance Integrate QA into the CI/CD pipeline for pre-deployment validation of updates Required Qualifications 3+ years in QA engineer

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 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

A company is looking for a Senior Actuarial & Analytics Consultant. Key Responsibilities Develop and deliver financial analyses and actuarial insights to support client decision-making Prepare reports and dashboards, coordinating with various stakeholders for data validation and analysis Manage

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

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

A company is looking for a DRG Validation Educator and Trainer.Key Responsibilities Train new staff on DRG Validation and system processes, including conducting audits and feedback sessions Create and deliver ongoing coding education and collaborate with physician leaders for content development

Job DescriptionPosition Summary Tire Agent is seeking a dedicated and analytical Pricing Analyst to join our team. The Pricing Analyst will play a crucial role in collaborating with the finance, supplier success, and marketing departments to develop effective pricing strategies and ensure competitive pricing while maximizing profitability. Tire Agent is looking for a curious, data-minded individual to produce high quality work in a fast-paced environment. The ideal candidate will possess strong quantitative skills, financial acumen, and the ability to work harmoniously across departments. Required: 2-4 years’ experience as a Pricing Analyst within the ecommerce or automotive aftermarket industry. General Responsibilities • Collaborate closely with the finance, supplier success, and marketing departments to formulate well-informed pricing strategies that align with financial objectives and market dynamics., • Analyze historical financial data, cost structures, and industry trends to provide informed recommendations for pricing decisions; work in SQL and Looker to analyze large sets of data., • Create financial models to assess the financial impact of various pricing scenarios on revenue, margin, and profitability; integrate cost components into pricing models to ensure precise pricing calculations., • Work in collaboration with finance professionals to evaluate the potential effect of pricing changes on overall profitability and the company's financial health., • Monitor the financial performance of implemented pricing strategies, analyzing actual outcomes against projected results; make recommendations for necessary adjustments based on observed performance., • Communicate pricing rationale and financial implications persuasively to stakeholders across functions., • Ensure the accuracy and integrity of financial and pricing data used in analysis and decision-making by implementing rigorous data validation processes and quality checks. Ideal Requirements • Bachelor's degree in finance, economics, business, or a related field., • Required: 2-4 years’ experience as a Pricing Analyst within the ecommerce or automotive aftermarket industry., • Strong understanding of BI technologies, particularly Looker, and data visualization best practices; knowledge of SQL or other coding languages is a plus, • Profound understanding of pricing methodologies, cost structures, and market dynamics., • Exceptional analytical and problem-solving capabilities., • Excellent interpersonal, communication, and collaboration skills with diverse teams., • Detail-oriented mindset to ensure precise financial calculations and analyses. BQrUFBCbj1

Job Description Job Title : Regulatory Support Location: Basking Ridge NJ Remote Option: Yes. But the candidate should be available to attend customer meetings twice in a month Requirements Mandatory skills: -experience in pharmaceutical environment. -Experience in regulatory environment is required. -High level exposure or knowledge about FDA inspection and internal audit process. -Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc. Job Title: Consultant JD details : -Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance. -Represents Regulatory Affairs on cross-functional project teams. -Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents. -Work with subject matter experts, and cross functional departments to support business needs. -Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation. -Gather and assemble information necessary for submissions in accordance with regulations/guidance. -Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary. -Conduct review of published submissions to ensure consistency and compliance with regulatory requirements. -Maintain knowledge of local and global regulatory submission requirements. -Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives. -Provide Regulatory Affairs support during internal and external audits and inspections. -Exposure in Change management process, requirement gathering, qualifying the changes etc., -Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc. -Consistently support for regulatory systems access and change management. -Responsible for communicating business process improvements, business related issues, status updates or opportunities. Qualifications: -Bachelors’ degree, preferably in a life science or a related field -5 to 10 years of experience in pharmaceutical environment. -Experience in regulatory environment is required. -Excellent written, verbal communication and presentation skills. -High level exposure or knowledge about FDA inspection and internal audit process.

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 SmartSource®, an ABCOM Technology Group company, has more than 35 years of experience serving clients' business technology needs in the events, staffing, legal, government, finance, education, entertainment, and meeting production industries. The company provides service throughout North America through its fully staffed and equipped offices in major metropolitan markets. SmartSource draws from its extensive inventory of IT, AV, and interactive technologies to deliver solutions as varied as computers for contract staff, office equipment for temporary spaces, or multi-story video walls for trade shows and events. The SmartSource team is passionate about leveraging its expertise to empower clients to excel. SmartSource will afford you an exciting career opportunity. We offer a fast-paced and dynamic work environment. Most importantly, you will be provided the support and environment to excel and succeed with an industry leading company. If you are enthusiastic, highly motivated and looking for a great opportunity, we encourage you to apply today. Job Summary: The Technical Specialist is a regionally assigned technical resource focused on high-demand event areas such as General Session Audio, General Session Video, and/or complex tradeshow booths including LED technology. This role ensures technical excellence and operational efficiency across regional events and serves as a developmental pathway toward Project Management. Key Responsibilities: • Operate independently in a specialized technical area after completing internal certifications and field validation., • Support the sales team by preparing accurate and technically sound proposals within their area of expertise., • Provide on-site technical execution for events, ensuring quality and consistency across deliverables., • Collaborate with Project Managers, Technical Leads, and fulfillment branches to align technical execution with event goals., • Assist with event logistics including labor coordination, equipment packaging, rentals, and freight services., • Troubleshoot and resolve AV and IT-related issues during setup and execution., • Maintain open communication with Account Executives and Project Management staff., • Occasionally fill other roles as needed, maintaining flexibility while prioritizing their core specialty., • Contribute to regional KPIs including proposal turnaround, personnel utilization, customer satisfaction, and event profitability., • Participate in cross-regional knowledge sharing and best practice alignment. Requirements: Must Haves: • Minimum 3 years of experience in the event industry, including hands-on project execution., • Strong background in area of focus (AV, IT, LED Walls), • Proficiency in configuring, networking, and troubleshooting computers, printers, and related hardware., • Strong problem-solving skills and ability to thrive under pressure., • Excellent interpersonal and communication skills., • Ability to work independently and as part of a team., • Technically savvy with MS Windows, Outlook, Word, Excel, and cloud-based applications., • Expect to travel regionally and occasionally support other regions (up to 70%) (Approx 20-25 events) Nice to Haves: • Bachelor’s degree., • Management and/or AV Rental Industry experience., • Specialized knowledge in AV applications, i.e. LED walls, Audio, Video, with appropriate certifications as appropriate Career Path: This role is designed as a stepping stone toward Project Management, offering exposure to proposal development, event execution, and cross-functional collaboration. SmartSource is an equal opportunity/affirmative action employer. SmartSource does not discriminate on the basis of race, color, religion, gender (including non-binary/third gender), transgender, gender identity or expression, sexual orientation or affectional preference, national origin, citizenship, age, disability, status as a protected veteran, military status, marital status, or status in any group or class protected by applicable federal, state, or local law. SmartSource makes reasonable accommodations for qualified individuals with disabilities in accordance with the Americans with Disabilities Act, Rehabilitation Act, and applicable state and local laws.

Job Description Be Part Of A Dynamic Team This opportunity sits within a well-established financial institution recognized for its commitment to regulatory integrity, strong governance, and a disciplined approach to risk management across the Americas. The compliance organization is structured, collaborative, and known for its high standards in protecting the business from financial crime exposure. The team works closely with multiple business units to strengthen transparency, support safe business growth, and maintain the accuracy of customer information throughout all stages of the client lifecycle. They are currently advancing several initiatives that focus on modernizing review processes, enhancing data quality, and increasing operational efficiency across KYC and financial crime controls. What’s In Store For You This role offers meaningful exposure to enterprise-level compliance functions and a chance to develop specialized expertise in KYC, CDD, and financial crime prevention. The position provides hands-on experience in client onboarding, regulatory reviews, audit readiness, and end-to-end data validation. You will be working in a structured environment that values precision, accountability, and consistent learning. The role is based onsite and provides the opportunity to work alongside experienced compliance professionals who support cross-functional development and internal growth. How You Will Make an Impact • Support onboarding and periodic review activities by gathering and validating customer documentation for accuracy and completeness., • Conduct customer due diligence reviews and assign risk ratings based on regulatory standards and internal guidance., • Review alerts and assist with preliminary research into potential financial crime concerns., • Maintain accurate customer information across compliance systems to support audits, quality checks, and regulatory expectations., • Identify gaps, deficiencies, or inconsistencies in client records and coordinate with internal teams to drive timely resolution., • Contribute to data remediation efforts and support broader initiatives that strengthen financial crime controls., • Help create a smooth and compliant onboarding experience that strengthens customer trust and reduces risk exposure for the institution. Are You an Experienced KYC and Due Diligence Professional Ready to Make an Impact? • One to three years of experience in KYC, AML, financial crime compliance, client onboarding, or a related regulatory function within financial services., • Strong understanding of regulatory concepts such as BSA, AML, sanctions screening, customer due diligence, and financial crime risk indicators., • Skilled in reviewing customer documentation, validating data, and identifying inconsistencies or missing information., • Proficient with Microsoft Excel, Outlook, and workflow-driven compliance systems used for data and case management., • Detail-oriented mindset with the ability to manage multiple cases while maintaining a high standard of accuracy., • Strong communication skills with the ability to handle sensitive information professionally., • Capable of working in a structured, documentation-heavy environment that prioritizes correctness and compliance., • ACAMS certification or related compliance training is beneficial but not required., • Bachelor’s degree in Finance, Business, Accounting, Economics, or a related field preferred.

Job Description 3108 Strong Core Java Developer + Rest API + Microservices + Azure Experience + Strong SQL Database + Experience in Firco (Sanction Tool or Similar tool) is must Location: NYC 3days/week onsite Interview - 1 Round Video + 1 F2F at client location Overall 12+ years of experience and recent 2 projects in Banking with Fixed Income experience is Must. We are seeking a highly skilled Senior Core Java Developer with extensive experience in RestAPI development, Microservices architecture, and Azure Cloud. The ideal candidate will possess strong SQL database expertise and have hands-on experience with Firco (Sanction Tool) to support our compliance and sanctions screening operations. Key Responsibilities: Design, develop, and maintain scalable and robust core Java applications. Build and optimize RestAPI services for seamless integration and communication across microservices. Architect and implement microservices using industry best practices. Deploy and manage applications in Azure cloud environment, ensuring high availability and performance. Develop and optimize complex SQL queries and design database schemas. Integrate and work with Firco (Sanction Tool) for compliance screening and sanctions validation. Collaborate with cross-functional teams to analyze requirements and deliver high-quality solutions. Conduct code reviews, provide technical guidance, and ensure adherence to standards. Troubleshoot, debug, and resolve production issues efficiently. Required Skills & Qualifications: Overall 12+ years of IT experience is required Strong proficiency in Core Java (Java 8+). Hands-on experience developing and consuming RestAPIs. Extensive knowledge of Microservices architecture and design patterns. Experience deploying, managing, and scaling applications on Azure Cloud Services. Strong SQL database skills (e.g., Oracle, SQL Server, PostgreSQL) including writing complex queries, stored procedures. Proven experience working with Firco (Sanction Tool) or similar sanctions screening tools.

Job DescriptionThe Role: This is an exciting opportunity to join ION as a Technical Consultant. As a Technical Consultant, you will be responsible for supporting client requests as well as maintaining client’s extensions, interfaces, and processes following best practices. Key Responsibilities:● Assume hands-on Center of Excellence (COE) duties for Openlink Endur and/or Findur throughout the engagement. Those include but not limited to, Business as Usual (BAU) support, static data maintenance, managing of client’s custom code and interfaces, running End of Day (EOD) activities, performing minor enhancements, fixes, and configuration of the system, liaising with ION’s Support Services team on core bugs or enhancements. ● Attend Product trainings to gain knowledge of the system’s functionality, architecture, and technical components.● Gain proficiency in one or more business areas.● Follow documentation standards and resolution process flow for all deliverables.● Follow delivery methodology standards.● Track deliverables to estimates and deliver on time. ● Keep Manager and engagement owner(s) informed regarding the status of assigned responsibilities.● Maintain full chargeability on client account(s) as assigned.● Travel to customer site to work on projects as needed.● Participate in requirements analysis, custom code development (design/configuration/testing) and provide support for the client’s business needs with some assistance from the team lead.● Gather and document technical requirements with guidance from lead, code to specifications.● Demonstrate strong reporting and development skills.● Adhere to ION’s best practices. ● Participate in Product deployment and configuration at client site or ION Cloud with some assistance from the team lead.● Gather and document system requirements, test plans/results, and any other deliverables required by the engagement.● Gain proficiency in one or more technical area for the system (interfaces, deployment, performance tuning, database analysis, etc.)● Setup internal ION Product Environments for testing and validation as needed.● Some travel to client site may be required. ● For EOD support, must overlap with US clients’ EOD run hours typically from 6pm to 11pm US Central Time.● For BAU support, must completely overlap EMEA CET hours and some US Eastern time coverage up to 12pm ET. Required Skills, Experience and Qualifications: • Openlink Endur/Findur Product experience in BAU and EOD support activities per role profile, • BAU support for lower complexity items such as reports and running internal processes, • Running EOD and troubleshooting as needed, loading prices, familiar with Openlink troubleshooting steps, log viewer configurations, reruns, etc., • Connex message hospital troubleshooting and reprocessing is a plus, • Worked on at least Openlink V18+, • Some exposure to OpenJVS, • Java knowledge as a foundation is required., • Bachelor’s or Master’s degree in Computer Science, Engineering, Finance, Accounting, Economics, or a directly related IT field., • 2+ years’ industry experience in Software Design and Development or deployment, • Experience with one or more of the following technologies: C# .NET, Java, C++, Soap Webservices, • Minimum 2-year experience with one or more of the ION products or another ETRM/CTRM, • Experience in designing, configuring, and troubleshooting installations of enterprise software in client environments is preferred., • Experience with RDBMS such Oracle or MS SQL Server is required., • Experience with writing SQL scripts in Oracle or MS SQL, • Experience with Interface implementation following industry standard integration patterns., • Fundamental networking knowledge, • Ability to follow system deployment steps with little guidance from senior team members, • Ability to follow design specifications with little guidance from senior resources., • Experience working with Integrated Development environments such as Visual Studio, Eclipse, Visual Studio Code, • Experience with source control and continuous integration tools (GIT, TFS, Confluence, Bamboo) and issue tracking systems (Jira, NetSuite) is required., • Experience with office productivity tools such as Word, Excel, PowerPoint, and SharePoint, • Strong understanding of relational database concepts, • Strong Object-Oriented Skills, • Strong analytical and problem-solving skills, • Good written and oral communication skills, • For on-site consultants, ability to work onsite at client locations as needed., • Ability to work as part of a project team structure

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 Description The L2 Automation Plant Engineer (Sea Vision) is responsible for the ongoing support, maintenance, and optimization of the plant's automation and control systems, with a specific focus on the Sea Vision serialization platform and associated machine vision systems. This role ensures maximum efficiency, compliance with industry regulations (e.g., GMP, FDA), and minimal downtime in a high-volume manufacturing environment. The engineer operates as a subject matter expert for assigned automation areas and may lead small to medium-sized projects or support larger capital initiatives. Requirements System Support and Troubleshooting: Provide 24/7 technical support for L2 automation systems, performing root cause analysis and resolving hardware and software issues with minimal guidance. Sea Vision Expertise: Serve as the primary Subject Matter Expert (SME) for the Sea Vision serialization and vision inspection systems, including configuration, programming (if required by the specific system setup), and troubleshooting. Maintenance and Optimization: Develop and manage plans to maintain and improve existing process control systems and vision technologies to enhance performance, reliability, and efficiency. Project Execution: Lead or support the implementation of new automation solutions, system upgrades, and interfaces, ensuring all work is executed in coordination with production schedules and change management standards. Validation and Compliance: Assist in the preparation and execution of Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), commissioning, and validation protocols (CSV) to ensure compliance with cGMP and regulatory standards. Documentation and Training: Develop and maintain detailed documentation, including User Requirements Specifications (URS), Functional Specifications (FS), Detailed Specifications (DS), SOPs, and training materials for end-users and maintenance staff. Collaboration: Work closely with cross-functional teams, including Manufacturing, Quality Assurance, IT, and maintenance personnel, to ensure seamless integration and alignment of automation activities with business goals. Vendor Management: Manage vendor service contracts and coordinate with suppliers for technical clarifications, support, and new technology evaluation. Required Skills & Qualifications: Education: Bachelor’s degree in engineering (Electrical, Mechanical, Automation, or Computer Science) or a related technical field. Experience: 4-6 years of experience in an automation or manufacturing support role, preferably within the pharmaceutical, biotech, or similarly regulated industry. Technical Knowledge: Proficiency with industrial control systems (PLCs, SCADA, HMIs) (e.g., Allen-Bradley, Siemens). Direct experience with Sea Vision serialization software and associated machine vision hardware (cameras, lighting, optics). Strong understanding of network protocols and IT/OT integration in a plant environment. Problem-Solving: Strong problem-solving skills to identify and resolve operational and quality issues efficiently. Attention to Detail: A high level of attention to detail to ensure accuracy in serialization, documentation, and quality control. Communication: Excellent written and verbal communication skills to effectively communicate with team members and management. Compliance Knowledge: Understanding of safety regulations, GMP, and relevant industry standards (e.g., 21 CFR Part 11).

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 DescriptionManage the Fixed Income derivative pricing/valuations function for a Global Investment Bank Responsibilities: • Perform Independent Price Verification (IPV) processes for Fixed Income products with emphasis on credit, rates and LATAM products, • Lead projects, implementing new processes, re-engineering and industrializing current processes. Ensuring handover and methodology documentation on the parameter review processes are up to date and signed off by management., • Propose innovative enhancements to valuation methodologies. Implementation through consultation with and validation from local and global risk and financial control groups., • Effectively manage relationships with Front Office, Risk and Research., • Communicate effectively with senior management the results of the IPVs and highlight ongoing issues., • Contribute to the evolution of the price verification processes. This includes identification of the instruments that create risk in the corresponding parameters and the assessment of alternative checking methods and sources. Analyze and question current processes and contribute to their improvement. Requirements: • Masters degree in Mathematics, Statistics, Engineering or Finance, • Relevant industry experience dealing with valuation and Independent Price Valuation, • In-depth Knowledge of valuation of all Fixed Income instruments including complex derivatives, swaptions, CDS, Repos, Loans, Interest Rate and Currency Swaps, Bond options, Corporate bonds and LATAM financial instruments., • Knowledge and understanding of options basics (Pricing/Models, Greeks, P&L effects, etc), • Excellent IT skills including VBA, Excel, Python, Power BI. Quick to assimilate new technology/systems and adapt into processes., • Strong written and oral communication, listening skills, • Knowledge of the best practice control framework for derivative valuation. For immediate consideration, please forward resume and contact details to: Ashton Lane Group is a boutique executive recruitment firm serving the Banking, Insurance, and Alternative Investment sectors. For the latest opportunities, visit Ashton Lane Group® “A trusted advisor throughout your career”

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 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 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 DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for clinical trials as well as PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs. Responsibilities: • Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance, • Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products, • Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission – safety component, • Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents, • Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed, • Effectively write, review and provide input on technical documents independently, • Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.), • Responsible for implementing risk management strategies for assigned products, • Proactively engaging, inspiring, coaching and mentoring team and colleagues, • Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader, • Strong team player, able to adapt and work in a fast pace environment, • Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Qualifications, • MD / DO with 2+ years of medical residency with patient management experience required; PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required, • 5 - 8 years of Pharmacovigilance (PST lead role equivalent) / Clinical Development experience in the pharmaceutical industry required, • Oncology experience strongly preferred, • Effectively analyze and guide analysis of clinical data and epidemiological information, • Effectively present recommendations / opinions in group environment both internally and externally, • Write, review and provide input on technical documents, • Work collaboratively and lead cross-functional teams, • Ability to lead cross-functional teams in a collaborative environment Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionOn-site Position Who You Are You are an innovative and detail-oriented Full-Stack Engineer with a passion for building reliable, secure, and scalable applications. You thrive in complex enterprise environments, enjoy collaborating with diverse teams, and are committed to continuous learning and technical excellence. You’re someone who finds energy in problem-solving, optimizing cloud architectures, and delivering high-quality software that directly impacts millions of users. You take ownership of your work, enjoy mentoring others, and value process discipline — especially in environments that demand precision, performance, and compliance. If you want to grow with a mission-driven company, contribute to world-class projects with global clients like JP Morgan Chase, and help elevate Latin American tech talent to its fullest potential, this is the role for you. Who We Are MAS means “more” in Spanish — and that’s what we stand for. We believe in providing more opportunities, more inclusion, and more impact. Founded by a Latina engineer from Medellín and based in Tampa, Florida, MAS Global Consulting is a 100% Hispanic and woman-owned company, recognized as a Great Place to Work and one of the Fastest-Growing Companies in the US. We connect top Latin American talent with North American clients to build digital, data, and cloud solutions. Our teams are currently helping world-leading organizations like JP Morgan Chase, Johnson Controls, and Dell to modernize platforms, deliver innovation, and scale digital transformation. How You Will Make Impact As a Full-Stack Java Developer, you will design, build, and optimize microservices and customer-facing applications that process massive volumes of secure transactions daily. You will work directly with Chase engineers under a time-and-materials engagement, embedded in agile delivery teams. Your contributions will drive real impact by improving system performance, enhancing observability, and enabling data-driven financial solutions at scale. Key Responsibilities • Design and develop RESTful APIs and microservices using Java (11+), Spring Boot, and Spring Cloud frameworks., • Implement event-driven architectures with Kafka (producers, consumers, schema management, and streaming)., • Deploy and manage services on AWS ECS/Fargate, using Terraform or CloudFormation for Infrastructure-as-Code and Spinnaker for CI/CD automation., • Integrate and maintain data flows with Cassandra, AWS S3, or Spark-based pipelines., • Collaborate with frontend teams using React or Angular to deliver seamless, full-stack solutions., • Leverage Python for automation, data validation, or integration scripting (nice-to-have)., • Ensure quality through Test-Driven Development, automated testing, and continuous integration practices., • Partner with DevOps and QA teams to enhance resilience, scalability, and performance across distributed systems., • Participate in sprint planning, design reviews, and retrospectives while following Agile/Scrum practices., • Champion best practices in security, code quality, and documentation, ensuring compliance with Chase’s standards.You Have:, • BS/BA degree or equivalent experience in Computer Science, Engineering, or related field., • 7+ years of experience building enterprise-grade applications using Java / Spring Boot., • Proven experience developing and deploying microservices on AWS Cloud (ECS, Fargate, Lambda)., • Solid understanding of Kafka, Docker/Kubernetes, and distributed system design., • Hands-on experience with CI/CD pipelines (Spinnaker, Jenkins, or GitHub Actions)., • Experience with frontend frameworks like React or Angular for full-stack delivery., • Familiarity with Cassandra, SQL/NoSQL databases, and data streaming concepts., • Working knowledge of Python3 for automation or data processing (nice-to-have)., • Exposure to observability tools like Datadog, Splunk, or Dynatrace for monitoring and troubleshooting., • Experience working in Agile environments and collaborating in cross-functional teams., • Excellent communication skills — able to explain technical concepts to both engineers and product stakeholders.Bonus Skills (Nice to Have):, • Knowledge of Apache Spark, Flink, or data engineering concepts., • Familiarity with financial services, regulated environments, or compliance-heavy systems., • Experience integrating AI/ML-powered recommendation systems or event-driven personalization logic., • Awareness of performance testing, NFR validation, and resilience patterns (DLQ, retries, fallback).Benefits, • Health: Medical, dental, and vision coverage., • Time Away: Vacation, holidays, wellness days, and parental leave., • Financial: 401(k), basic life, and AD&D insurance. Powered by JazzHR 1Vxvxla96D

Job DescriptionThe Role: We are seeking a Business Analyst to support the development and delivery of our order routing products. The ideal candidate will have strong analytical skills, a good understanding of financial markets, and an interest in learning the technical components of complex trading systems. This role will work closely with the Senior Business Analyst and cross-functional teams to ensure high-quality, well-structured solutions.Key Responsibilities: • Assist in gathering and documenting business and technical requirements from internal and external stakeholders., • Support analysis and documentation related to:, • Messaging flows between routing components, clients, and exchanges, • API mapping requirements, • Data model for system entities, • Order processing logic and workflow rules., • Contribute to impact analysis, solution planning, and validation during testing and deployment cycles., • Assist in solution planning, impact analysis, and project implementation., • Maintain clear, structured documentation including requirements, workflow diagrams, use cases, and test scenarios., • Minimum of 2-4 years’ experience as a Business Analyst in a financial services, trading, or technology firm, • Foundational understanding of US equities and/or options, • Ability to manage multiple projects simultaneously in a high-pressure, time-sensitive environment., • Excellent communication skills with the ability to interact effectively with technical and non-technical teams., • Good understanding and experience with the software development lifecycle, • Exposure to networking concepts (TCP/IP, APIs etc.).

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 About Futu US Inc.: Futu US Inc. stands at the forefront of financial services, housing two SEC registered broker-dealers alongside a cryptocurrency brokerage — all operating under the reputable wing of Futu Holdings Limited (Nasdaq: FUTU). Our core mission revolves around innovating the investing landscape through a digitized brokerage and wealth management platform that's designed to elevate the investment experience. Here's a closer look at our key entities: • Futu Clearing Inc.: An SEC registered FINRA member dedicated to delivering top-tier clearing and execution services globally., • Moomoo Financial Inc.: As an SEC registered FINRA member, we provide retail investors access to both U.S. and Asian securities markets, ensuring your investment journey is backed by expertise. About the Role We are seeking a reliable, adaptive, and detail-oriented Cash Management Analyst to support our finance team. This entry level role is ideal for someone who thrives in a data-driven environment and is passionate about automation, accuracy, and financial systems. You’ll play a key role in maintaining smooth cash flow operations across multiple entities, banking portals, and internal systems. As a Cash Management Analyst, you will assist with daily cash operations, bank reconciliations, and automation initiatives. You’ll work across multiple banking platforms and internal systems to ensure liquidity and accuracy in financial transactions. This role offers exposure to treasury, operations, financial reporting, and cross-functional collaboration with Settlements, Operations, and Accounting teams. What You’ll Do • Perform daily cash position reporting and reconciliation across multiple bank portals., • Assist in automating cash management workflows using Excel, macros, and other tools., • Support data entry and validation for transactions and bank activities., • Monitor and maintain bank balances, ensuring sufficient funding for multiple accounts., • Collaborate with finance and other teams to resolve discrepancies and optimize processes., • Help maintain documentation and SOPs for cash management procedures. Qualifications • Bachelor’s degree in finance, accounting, business, or related field., • Strong proficiency in Excel (pivot tables, formulas, macros); experience with automation tools is a plus., • Detail-oriented with excellent organizational and time management skills, along with effective communication abilities, are essential for success in this role., • Reliable and adaptable in a fast-paced, evolving environment., • Experience with automation platforms (e.g. Python scripting)., • Familiarity with banking portals and/or financial reporting tools., • Understanding banking processes and or accounting. Benefits What We Offer: • Competitive salary and performance-based bonuses., • Comprehensive benefits package, including health, dental, and retirement plans., • Opportunities for professional growth and development. Disclaimer The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Futu Holdings Limited, including all subsidiaries, is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability status, protected veteran status, or any other characteristic protected by law. Warning about fake job posts Please be aware of fraudulent job postings by persons not affiliated with Futu, Moomoo, or their affiliates. Criminals may use fraudulent job postings to obtain your personally identifiable information and/or financial information to steal your identity and/or money. All communications to you will come from a business email address. We do not hire through text message, social media, or email alone, and any interviews will be conducted in person or through a video call. We will not ask you for bank account information nor ask you to pay anything during the hiring process. If you see suspicious activity or believe that you have been the victim of a job posting scam, you should report it to your local FBI field office or to the FBI’s Internet Crime Complaint Center.

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 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 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 DescriptionCompany Description WHO WE ARE fresh is a global company headquartered in New York offering a full lifestyle line spanning skincare, lip care, bodycare, and fragrance in over a dozen countries. But we don’t just aspire to make the best products on the market; we want to be the best beauty brand to work for. We’ve created a warm, inspiring environment with world-class benefits that encourages our teams to dream big, because that’s how we got here. Here at fresh, we intentionally foster a spirit of belonging. We celebrate our diversity and support every employee to feel welcomed, valued, respected, and heard. By embracing curiosity and collaboration, we recognize that our differences strengthen us. Job Description MAIN JOB OBJECTIVE The Associate Manager, Packaging Development will support the company growth by developing and implementing innovative packaging for the Promo Category. This includes, but not limited to, development of set boxes, GWP and collateral items. Reporting to the Vice President, Product Innovation, the Associate Manager will work cross-functionally with many Global partners inclusive of Marketing, Product Development, Packaging Design and Operations. Additionally, the Associate Manager, Packaging Development will be a key contact with external packaging vendors, a critical element of the position. With an excitement for sustainable packaging, the Associate Manager, Packaging Development will have exceptional project management skills and constantly operate with a solution-oriented mindset. Qualifications JOB RESPONSIBILITIES • Execute the development and qualification of packaging solutions for Promo category that meet the needs for brand aesthetics, consumer use, manufacturing capability, quality and cost, and market requirements, • Support the conceptualization, initiation, development, validation and implementation of new and improved packages and processes including design generation, engineering specifications, mold qualification, functionality and quality testing, • Support operations cost savings and efficiency initiatives, and quality investigations towards continuous improvement, • Fully own technical milestones in project timelines, • Troubleshoot technical issues (supplier, plant, distribution, quality, etc.), • Share and escalate roadblocks cross-functionally, • Create package component specifications, pre-Bills-of-Materials and Fill & Assembly specifications and quality control elements, • Collaborate with Marketing and Design on establishing feasibility for new packaging initiatives/concepts, • Validate artwork based on mandatory technical elements and subsequently validate proof per released artwork, • Ensure colors of packaging components meet Design expectations and are within molding and decorating process constraints outlined by external suppliers, • Understand and conduct package testing procedures and standards to support the effective design, validation, and implementation of new packages and packaging technology, • Manage external vendors/supplier relations to review project status, elevate technical solutions, and build innovation, • Attend Set Assembly startups as needed to ensure proper execution of design & function, • Support and drive engineering change initiatives, • Gain full understanding of Fresh procedures and processes in Gifting, New Product Development and ECR's (Engineering Change Request), • Work closely with Packaging Development team, understanding key packaging deliverables for new launches, • Build relationships with cross functional fresh teams, internal LVMH partners, and external vendors, • Optimize current packaging development processes and finding creative solutions for packaging innovation, • Partner with preferred vendors, track current and future offerings related to sustainability, innovation, supplier constraints, and capabilities, • Present to partners on innovative and sustainable packaging, • BS/BA degree in Package Engineering/Technology/Science or related engineering field, • Minimum 3 years relevant experience in Packaging Development (preferred in Gifting), • Demonstrated broad and in-depth knowledge of packaging materials and processes, • Demonstrated success of excellent communication skills, both oral and written, with internal partners and external vendors, • Self-motivated and self-disciplined individual, able to work in relative autonomy, • Proficient PC skills - MS Office software and capable of building presentations on Excel and/or PowerPoint., • CAD literacy will be a plus Additional Information WHAT WE OFFER YOU Training & Development and Culture • Fresh and LVMH Sponsored Trainings and Workshops for Personal and Professional Development, • Opportunities for networking and building relationships with LVMH Community and Network, • Free professional consultation, referrals and counseling through the Employee Assistance Program (EAP), • Comprehensive paid time off inclusive of Floating Holidays and Summer Fridays, • Fertility Services, Maternity and Newborn Support, Adoption and Surrogacy Assistance, including cryopreservation when part of fertility treatment, • Paid Parental Leave (Inclusive of Maternity, Paternity, Adoption, Surrogacy) at eligibility, • Travel & lodging for those who can’t access care, • Fresh In-Store Discounts and Gratis, • LVMH Group Friends and Family Sales across all divisions within LVMH: Wines and Spirits, Watches and Jewelry, Perfumes and Cosmetics, Fashion and Leather Goods, etc., • Pre-Tax Commuter Benefits through Wage Works The salary range for this role is $80,000 - $105,000 USD. This role is based in Jersey City, New Jersey. All your information will be kept confidential according to EEO guidelines.

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 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 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