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Job DescriptionBenefits: • 401(k), • Bonus based on performance, • Competitive salary, • Dental insurance, • Employee discounts, • Health insurance, • Opportunity for advancement, • Paid time off, • Training & development, • Vision insurance This is for the true rainmakers, the entrepreneurial spirits who thrive on autonomy and whose confidence is backed by a proven track record. If the idea of unlimited earning potential, tied directly to your performance without a safety net, excites you more than it intimidates you might be one of the rare individuals we seek. However, if the security of a base salary is essential, or if you doubt your ability to consistently generate significant results from day one, this path is not for you. Who We Are: We're Unblinded a movement empowering leaders and organizations globally. We offer proven frameworks that accelerate growth and deepen connection. This commission-only role is a strategic partnership for elite sales professionals who want complete control over their income and impact, leveraging our powerful brand and methodology. Who You Are: A Proven sales expert & Business Builder: You have a history of exceeding targets in high-ticket, commission-based environments. You don't just sell; you build relationships and create long-term value. Highly Autonomous & Resourceful: You excel without hand-holding, proactively identifying opportunities, crafting strategies, and overcoming obstacles. Master Communicator & Influencer: You articulate value propositions with exceptional clarity and build deep trust, navigating complex sales cycles with finesse. Financially Astute & Resilient: You understand the commission-only model and have the financial runway and mental fortitude to thrive in it. Intrinsically Motivated & Growth-Oriented: Your drive comes from within, fueled by a desire for mastery, impact, and uncapped success. You embrace continuous learning. What You'll Do: • Leverage your network and expertise to identify and engage high-potential prospects for Unblinded's programs (may involve both inbound qualification and outbound generation)., • Orchestrate the entire sales process, from initial contact through discovery, value demonstration, proposal, and closing agreements., • Master and embody Integrity-Based Human Influence in every interaction., • Build and nurture a robust pipeline, potentially developing strategic partnerships or referral networks., • Collaborate strategically with Unblinded leadership, accessing resources while driving your own results., • Take complete ownership of your performance and earnings. Why This Unique Partnership? Unlimited Earning Potential: Zero caps. Your income is a direct reflection of the value you create and the agreements you secure. Significant Residual Income: Build a growing, recurring revenue stream based on long-term client success. Maximum Autonomy: Define your own strategies, schedule, and approach within our ethical framework. Be your own boss, powered by our platform. Access to World-Class Training: Benefit from our intensive Integrity-Based Human Influence coaching to continuously sharpen your edge. Associate with a Premium Brand: Leverage Unblinded's reputation and transformative offerings to open doors and close deals. Profound Impact: Facilitate life-changing growth for clients while building your personal empire. Qualifications: • Extensive, documented track record of exceptional performance in commission-only or high-stakes B2B sales roles (e.g., high-ticket coaching, consulting, enterprise software)., • World-class negotiation, influence, and relationship-building skills., • Deep understanding of complex sales cycles and value-based selling., • Entrepreneurial mindset with outstanding self-discipline and resourcefulness., • Financial stability to support a commission-only ramp-up period. Apply Now and let's discuss building something extraordinary together.

The Food Scientist I reports directly to the Product Development & Commercialization Lead and is responsible for translating validated technical platforms into scalable, launch-ready commercial products within the snack and confectionery portfolio. This role focuses on formula finalization, scale-up execution, supplier coordination, and commercialization readiness. The position plays a critical role in ensuring products move efficiently from development to successful market launch while meeting performance, quality, and compliance requirements. The Food Scientist I operates within the Product Development & Commercialization Team and works cross-functionally with Technical & Research, QA, Operations, Procurement, Engineering and external suppliers. Key Responsibilities: 1. Formula Finalization & Optimization · Refine and finalize product formulations for commercial readiness. · Optimize formulas for manufacturability, cost targets, and sensory performance. · Align bench, pilot, and production formulations. · Maintain master formulas in designated systems (e.g., SpecRight). · Ensure formula accuracy aligning with NFP and artwork. 2. Pre-Launch Analytical Validation · Coordinate and verify required analytical testing prior to commercialization. · Establish internal product quality standards (texture, moisture range, sensory benchmarks). · Review analytical data to confirm product consistency and compliance with specification limits. · Ensure discrepancies between formula and analytical output are resolved prior to launch. · Support validation of NFP calculations through correct formula alignment. 3. Pre-Launch Compliance & Regulatory Validation · Ensure formula used for NFP matches production activities with allowed variations. · Confirm documentation required for audit and regulatory review is complete before launch. · Proactively identify compliance risks during development phase before artwork is finalized. 4. Scale-Up & Commercial Trials · Plan and execute pilot and commercial production trials. · Define and validate critical process parameters in collaboration with Operations. · Troubleshoot production challenges (texture variation, moisture migration, ingredient interactions). · Document trial outcomes and quality information. 5. Launch Execution & Cross-Functional Coordination · Coordinate cross-functional launch readiness activities. · Ensure all documentation (formula, specification, analytical validation, compliance review) is complete prior to commercialization. · Partner with QA Compliance for final label approval. · Participate in sprint reviews and escalation discussions led by the Project Manager. 6. Portfolio Management & Continuous Improvement · Support cost optimization and formula renovation initiatives. · Investigate product performance complaints (staleness, hardness, sensory deviation). · Implement corrective actions to maintain product quality and brand integrity. Qualifications: Master’s degree in Food Science, Food Engineering, or related field. 1–3+ years of experience in snack and/or confectionery product development. Experience supporting pilot and commercial production. Working knowledge of: Water activity & moisture control; Texture analysis; Nutrition labeling fundamentals; Basic FDA labeling and compliance requirements

Security Systems Technician Needed $34 - $42 an hour We are looking to hire a Lead Security Systems Technician for the Passaic County NJ market. We are a Security Systems and Life Safety solutions company supporting large scale enterprise level companies. Our team continues to grow. We are seeking an experienced Security Systems Technician to perform installation and maintenance of electronic Access Control Systems, CCTV, and related low-voltage security infrastructure. This role is hands-on and technical focused, serving as the technical expert on job sites and ensuring projects are delivered safely, on time, and to specification. The Lead technician will be considered as a Subject Matter Expert Required: • Must hold previous long term experiences with security system installations/servicing, • Must be willing to work in teamed environments, • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. About TEKsystems and TEKsystems Global Services We're a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We're a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We're strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We're building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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

Job Locations US-NJ-Paramus ID 2026-1963 Category Information Technology Type Regular Full-Time The Senior Manager, Commercial IT Data Engineer is a hands-on technical role responsible for designing, building, and maintaining enterprise data integrations and commercial data pipelines supporting life sciences operations. A strong foundation in SQL and relational data modeling is essential, as the role will regularly analyze, validate, transform, and optimize large commercial healthcare datasets. This role supports Snowflake analytics environments, IQVIA data ingestion (including Xponent, DDD, Prescriber/HCP, HCO, OneKey reference data, and affiliation datasets), and master data platforms including Reltio (preferred) or equivalent MDM solutions. The position partners closely with Commercial Operations, Data Operations, and managed service vendors to ensure reliable, scalable, and audit-ready data flows. Success in this role requires deep expertise in Reltio and/or on-premise MDM platforms, a strong understanding of Master Data Management principles, data governance, and data quality practices. Advanced SQL skills, experience with ETL tools, and familiarity with metadata management and data integration best practices are essential. Strong analytical thinking, problem-solving, and troubleshooting capabilities are also critical. Design, develop, and maintain enterprise data integrations across CRM, MDM, Snowflake, and external data providers. • Write, optimize, and troubleshoot complex SQL queries to support data ingestion, transformation, reconciliation, and validation., • Build and support ingestion pipelines for IQVIA datasets including Xponent prescription data, DDD datasets, OneKey reference data, Prescriber (HCP), and HCO data., • Process and integrate IQVIA affiliation datasets to support healthcare provider-to-organization relationships and hierarchy mapping., • Use SQL to investigate data issues, reconcile commercial datasets, and validate transformation logic., • Develop scalable Snowflake data models optimized for large commercial healthcare datasets., • Implement source-to-target mappings for IQVIA files including deciles, specialty alignment, territory mapping, brick-level data, and affiliations., • Support customer master alignment between IQVIA datasets, CRM platforms (e.g., Veeva), and Reltio or Informatica MDM platforms., • Support master data governance processes including survivorship rules, crosswalk mappings, golden record creation, and hierarchy management., • Develop automated validation, reconciliation, and monitoring controls for prescription, prescriber, and affiliation data., • Review vendor-delivered integration logic and SQL transformations to ensure scalability, performance, and maintainability., • Troubleshoot integration failures, transformation issues, API exchanges, and Snowflake performance bottlenecks., • Maintain Dev/Test/Prod deployment discipline and version control best practices., • Document transformation logic, SQL validation procedures, data lineage, and IQVIA file processing standards to support audit readiness., • Bachelor's degree in Computer Science, Information Systems, Engineering, or related field preferred. Certifications in Snowflake, SQL, data engineering, or MDM platforms are a plus., • 3-7 years of hands-on data engineering or data integration experience within life sciences, pharma, or biotech., • Strong SQL expertise with ability to write complex queries, troubleshoot data issues, and optimize query performance., • Direct experience working with IQVIA commercial datasets including Xponent, DDD, Prescriber (HCP), HCO, OneKey reference data, and affiliation files., • Understanding of healthcare commercial data structures including prescriber hierarchies, affiliations, specialties, deciles, territory alignment, and brick-level geography., • Experience supporting enterprise data integrations using ETL tools, APIs, or file-based exchange processes., • Experience with Snowflake or other cloud data warehouse platforms., • Experience supporting or integrating with Reltio MDM (preferred) or equivalent master data platforms., • Experience with migrating from Informatica MDM to Reltio MDM is a plus., • Understanding of data stewardship practices and master data governance principles., • Strong debugging, reconciliation, and root cause analysis capabilities.

Job Description Our client, a well established (and still growing) Managed Service Provider (MSP) in Northern NJ is searching for a Level 1 Service Desk Technician. This is an onsite role. In this role YOU will: * Triage incidents - Intake via portal/email/phone * Resolve common end-user issues (and escalate appropriately) * Work within their PSA/RMM stack (Halo PSA + NinjaOne) and operate to documented SLAs * Remote Support & Troubleshooting: Use NinjaOne and remote-control tools to resolve desktop/laptop/peripheral issues (Windows/macOS), Microsoft 365 apps (Outlook, Teams, OneDrive, SharePoint), and common line-of-business applications. * Account & Endpoint Administration: Password resets, AD/Intune tasks (device enrollment, policy checks), software installs/updates, AV/malware remediation. * Networking Basics: Verify connectivity (DNS/DHCP), printer/scanner mapping, VPN client checks; capture key details (IP, firmware, drivers) to aid escalation. * Knowledge & Documentation: Contribute runbooks/KB notes; keep ticket histories complete and audit-ready; align with governance reporting (daily/weekly operational dashboards, monthly summaries, QBR inputs). * Onboarding/Offboarding Support: Prepare endpoints, apply baseline policies, and follow checklists that support standardized environments (e.g., Ubiquiti UniFi networking). YOU might be the right person if YOU have: * MSP Experience (Required): 1+ year on a service desk in a Managed Services environment handling multi-tenant clients, PSA/RMM tools, and SLA commitments. * Technical Foundations: o Windows 10/11 (user profile, updates, drivers), basic macOS support o Microsoft 365 (Exchange Online, Teams, OneDrive/SharePoint), Outlook troubleshooting o Basic networking (TCP/IP, DNS/DHCP, Wi-Fi), printers/scanners, VPN clients o Endpoint security (AV/malware tools), software deployment/update hygiene • * Tools: Practical familiarity with Halo PSA (ticketing, prioritization, SLAs) and NinjaOne (RMM, remote control). * Professional Skills: High empathy and customer service, clear written/verbal communication, disciplined documentation, time management, and a strong sense of urgency. * Nice-to-Have (Preferred) • Exposure to Ubiquiti UniFi networking environments. Basic PowerShell scripting, Intune device management, Azure AD administration. Experience with backup/DR agents and endpoint encryption. Our client offers a base salary between 40 and 48K plus benefits (medical, PTO, holidays, professional development). Master Search Solutions is a direct hire recruiting firm that specializes in the New Jersey marketplace. We have nearly 30 years of experience connecting top talent with leading businesses. We are committed to (and celebrate) diversity, equity, and inclusion.

Job Description Job Title: Engineer (Mechanical/Electrical/Computer) Location: Philadelphia, PA Company Overview: Continental Tide Defense Systems, Inc. (Continental Tide) is a premier provider of engineering and industrial services, proudly supporting the U.S. Navy, U.S. Coast Guard, Military Sealift Command, and other Department of Defense (DoD) organizations. We are committed to fostering a collaborative culture where every employee's voice is valued, and opportunities for growth and development abound. At Continental Tide, you'll thrive in a fast-paced, dynamic environment that encourages innovation, skill-building, and the pursuit of excellence. Join our team of dedicated experts who are passionate about delivering cutting-edge solutions to support our nation's fleet. We look forward to welcoming you aboard! Job Description: We are seeking a highly skilled Engineer with expertise in mechanical, electrical, or computer systems to support critical tasks for naval and maritime operations. This role involves conducting detailed technical reviews, project management, and engineering support to ensure the accuracy, functionality, and quality of ship systems and installations. Key Responsibilities: \n • Provide engineering support for Air Conditioning and Refrigeration (AC&R), Steam, Auxiliary, Combat Support, Life Support and Ventilation, and/or Compressed Air Systems.\n, • Provide programmatic, engineering/technical support, test procedure development, testing, and onsite coordination support for programs, including Machine Alterations (MACHALTs), engineering change proposals. and/or ship change documents (SCDs).\n, • Provide market research, engineering support, and recommendations to resolve obsolescence issues.\n, • Provide Ship system configuration, testing, training, support, troubleshooting, and assessments of HM&E systems.\n, • Conduct pre- and post-installation ship checks to verify installation drawing accuracy.\n, • Support Integrated Logistics Support (ILS) development, certification packages for MACHALTs, and/or SCDs.\n, • Develop and track Plan of Action, and Milestones (POAMs) for related programs and projects.\n, • Provide strategic planning and analysis of requirements to assist in developing a fully Integrated Master Schedule (IMS).\n, • Actively participate in the NSWCPD System Engineering Program (SEP), which includes attending meetings; completing action items; participating on sub teams, and participating in training, and assessments. Provide support for Systems Engineering Plan tools and processes.\n, • Ensure proper equipment and logistic configurations for technical accuracy.\n, • Perform Technical Assessment Team (TAT) reviews to ensure the delivery of quality products to the Fleet. \n, • Develop and present fully automated advanced fluid system models using industry-standard software. \n, • Analyze the impacts of potential ship alterations or modifications to existing shipboard systems.\n\n Experience and Skills Requirements: \n • Bachelor's degree in any engineering discipline from an accredited college or university.\n, • Seven (7) years of experience in: Navy Ship Auxiliary systems, including distributed machinery\n, • control systems and software; Auxiliary Fuel, and Lube Oil systems; Auxiliary Pumps, and Smart Valves; Auxiliary Machinery, and the testing of these systems.\n, • Knowledge of NSWCPD System Engineering Program (SEP), Alterations (MACHALTs), engineering change proposals, and/or ship change documents (SCDs) processes.\n, • Experience with Integrated Logistics Support (ILS) development and obsolescence management.\n, • Proficiency in interpreting technical drawings and schematics.\n, • Experience in project management, engineering support, and system configuration.\n, • Knowledge and experience with naval ship systems including fuel and lube oil, pumps, heat exchangers, smart valves, auxiliary machinery and the testing of these systems.\n, • Must have the ability to obtain a SECRET clearance.\n Why Join Us? At Continental Tide, we foster a culture of collaboration, innovation, and professional growth. By joining our team, you'll work on impactful projects supporting our nation's fleet, with opportunities to advance your career in a fast-paced and rewarding environment. Apply Today: If you're ready to make a difference, we encourage you to apply and become a part of our mission to deliver quality solutions to the Fleet. Reasonable Accommodations Statement: To perform this job successfully, an individual must perform the essential job duties satisfactorily with or without reasonable accommodation and without posing a direct threat to the safety or health of employee or others. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Job Benefits Benefits: Learn more about us: See all of our latest opportunities at or follow us on our LinkedIn page at:. To be considered you must apply by going to . Continental Tide is an Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity. Continental Tide participates in E-Verify and U.S. citizenship is required for most positions. "This contractor and subcontractor shall abide by the requirements of 41 CFR 60-300.5(a). This regulation prohibits discrimination against qualified protected veterans and requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans."

Division:SourceBlue Project Location(s):Saddle Brook, NJ 07663 USA Minimum Years Experience: Travel Involved: Job Type:Regular Job Classification:Experienced Education: Job Family:SourceBlue Compensation:Salaried Exempt SourceBlue is a subsidiary of Turner Construction Company that has been purchasing materials and equipment for major construction projects since 2001. With a staff of 350+ dedicated professionals and ~$1B in equipment and materials procured annually, we provide Clients with comprehensive supply chain services that are unmatched in the industry today. Internal Applicants: This position can be performed from any Turner office. Position Description: Overall responsibility for the management of the Procurement Department Reports to: Preconstruction Manager or General Manager Essential Duties & Responsibilities*: Lead, develop and manage the procurement staff, including completing performance evaluations. Manage the subcontractor prequalification process. Oversee the maintenance of the master subcontractor list. Interact and maintain close contact with the subcontractor market to monitor subcontractor workloads and watch trends and market conditions. Foster and enhance subcontractor relationships. In conjunction with Community Affairs Department, conduct subcontractor outreach for small, minority, women-owned, and disadvantaged businesses. (M/W/DBE) Maintain ongoing communication with project staff with regard to subcontractors' performance. Participate in and assist with presentations and proposals. Work hand-in-hand with Estimating and Operations in developing and implementing bidding strategies when assembling competitive bids and proposals. Assist Operations in creating the General and Specific Conditions, safety requirements and scope requisitions for each project to ensure that the scope, schedule, M/W/DBE requirements, insurance and bonding requirements are clearly defined for the bidders. Examine the plans and specifications for any deficiencies, construction issues, and technical questions and refer any findings to the Project Engineer. Enforce Turner's standards of safety, Quality Assurance/Quality Control (QA/QC), ethics and core values as set forth in the Company's policies. Develop a comprehensive working knowledge and understanding of the contract documents to ensure all procurement requirements within scope are accomplished within budget. Establish and/or work with the job staff in establishing the procurement schedule of the job. Oversee and manage the bid, negotiation and award processes for all subcontractors and vendors. Receive bids, prepare spreadsheets, conduct scope review meetings with competitive bidders (with Operations staff in attendance as required) to confirm that bidders have complied with scope requirements, alternates and unit pricing, manpower, schedules and logistics plans, M/W/DBE requirements, insurance and bonding requirements, and any other project-specific requirements. Evaluate available subcontractors to determine optimal selection for the project. Produce Subcontractor Approval Requests (SARs) and submit for further approval. Work with Operations to manage subcontractor failures, claims, liens, surety issues, etc. Prepare and issue subcontracts and follow up for timely execution of the subcontract,other project-specific items that must be submitted to complete the subcontract process. receipt of insurance certificates and Payment and Performance (P&P) bonds, and any Maintain current insurance certificates, bonds, and consent of surety for reserve reductions, off-site material payments and final payments. Conduct subcontractor evaluations at project completion, in conjunction with Operations. * Qualifications: Bachelor's Degree plus minimum of ten years of construction experience, including three years of Procurement experience, or equivalent combination of education and experience. Must have strong interpersonal, leadership, risk management, and negotiation skills. Should have a thorough understanding of contractual language, indemnity, insurance and company policy. Strong computer skills and familiarity with current software and programs (Microsoft Office Suite of programs, SAP, SharePoint). Very strong verbal and written communication skills required. Physical Demands: Performance of the required duties will require physical ability to climb permanent and temporary stairs, passenger use of construction personnel hoists, ability to climb ladders and negotiate work areas under construction. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus. Performing this job requires use of hands to finger, handle, or feel objects, tools or controls, sit, talk and hear, stand, climb, balance, stoop, kneel, crouch, or crawl. Employee must occasionally lift and/or move up to 50 pounds. Work Environment: While performing the duties of this job, the employee regularly works on-site at the construction work site where the employee is exposed to moving mechanical parts; high precarious places; fumes or airborne particles; outside weather conditions and risk of electrical shock. The noise in these work environments is usually moderate to very loud. *May perform other duties as assigned. *The salary range for this position in Denver is estimated to be $160K-$230K annualized. * *The salary range for this position in California is estimated to be $160K-$240K annualized. * *The salary range for this position in Chicago is estimated to be $1400K-$210K annualized. * Turner is an Equal Opportunity Employer -minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity.VEVRAA Federal Contractor Apply NowShare Save Job

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

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

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

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

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

Job DescriptionReports to: GCOQ – Global Chief of Quality (Functional/Global Alignment) Department: Quality Assurance / Quality Control Supervises: Regulatory Associates, Technicians Organizational Relationships: QA/QC, Production, Warehouse, Engineering, R&D, Sales Project Managers, Account Executives, Operational Personnel, Customers, Regulatory Agencies, External Vendors/Suppliers, Global Quality Teams Responsibility Summary: The Manager – Regulatory is responsible for supporting site regulatory operations while ensuring alignment with global regulatory strategy and corporate quality standards. This role oversees regulatory compliance, submissions, raw material management, and cross-functional coordination to ensure full adherence to applicable global regulations. The position serves as the primary regulatory lead for operational execution at the site and ensures effective communication between site operations and global quality leadership. Responsibilities: • Oversee issuance of Raw Material regulatory statements including Origin, REACH, Allergen, Nitrosamine-Free, EU/China compliance, and other global declarations., • Direct vendor communication and ensure timely collection and verification of regulatory documentation., • Review and approve compliance documentation (CoCs, CoAs, CoMs, BSE, CMR, SDS, RM documentation, etc.) for domestic and international requirements., • Support regulatory submissions related to Organic (USDA/Ecocert), Gluten-Free, MoCRA, CARES Act reporting, and other regulatory programs., • Oversee regulatory compliance documentation generated through internal and third-party systems., • Conduct regulatory review of formulas and ingredients to ensure compliance across all intended markets; proactively identify regulatory risks and implement mitigation plans., • Support the development, review, and maintenance of Product Master Files (Dossiers), Drug Master Files (DMF), and global regulatory submissions., • Support preparation, coordination, and response activities for regulatory inspections, cGMP audits, and environmental audits., • Ensure ongoing compliance with FDA (21 CFR 210/211/820), EPA, OSHA, TGA, Health Canada, ISO, EU, China CSAR, Japan, and other applicable global regulations., • Support regulatory-related SOP development, Change Control, and QMS compliance., • Monitor evolving global regulatory requirements and implement necessary updates to maintain compliance., • Provide regulatory leadership guidance to cross-functional teams and support global quality initiatives., • Act as regulatory delegate for the site, as required. Qualifications: • Bachelor’s Degree in Life Sciences, Engineering, or related field., • Minimum 5 years of regulatory experience in pharmaceutical, cosmetic, medical device, food or related regulated industry, • Working knowledge of FDA regulations (21 CFR 210, 211, 820), • Strong leadership, cross-functional influence, and communication skills, • Analytical and regulatory risk assessment capability Compensation & Benefits: • The approximate pay range for this position is $75,000 to $90,000 per year. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. Powered by JazzHR f3g5lWItFW

Job DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Track and trend relevant quality metrics including environmental monitoring data., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • Computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Our client, a leading New Jersey based family style entertainment provider, is searching for a VP of Construction. The selected candidate will lead the planning and execution of various scale construction projects. This leadership role is responsible for overseeing all phases of construction—from budgeting and scheduling to implementation and delivery—ensuring projects are completed on time, within scope, and on budget. In this role YOU will: • Collaborate with internal stakeholders, architects, engineers, and external partners., • Monitor project progress and proactively address risks and delays., • Implement cost-effective strategies and value engineering solutions., • Provide executive-level reporting and updates to senior leadership., • Maintain compliance and quality control of job site operations ensuring adherence to quality standards, design, specifications, timeline/scheduling while staying within budget, • Communicate with project team regarding ASI’s, RFI’s and Material submittals, • Coordinate required inspections with local jurisdictions, • Maintain accountability of subcontractors to ensure execution and compliance with the contracted scope of work, • Identify subcontractor non-compliance with safety, health and environmental quality standards, • Ensure subcontractor has corrected all identified deficiencies., • Track, review and maintain daily written log of activities on the jobsite, • Assist in budgeting, bidding, and award of subcontracts, • Lead the obtaining or permits and approvals for revisions, • Collect project material submittals and maintain records of approvals at the job site, • Walk all units on daily basis to monitor activities and assist in future planning, • Lead weekly subcontractor and consultant meetings designed to coordinate work, • Lead pre-construction meetings with each subcontractor, vendor and consultant, • Demonstrate continued direct, open dialogue with the project team regarding any deviation in the direction of the project regarding work, job conditions, subcontractor relations, etc., • Promote positive and cohesive relations with subcontractors by dealing professionally and fairly with all subcontractors and vendors, instilling this philosophy in project team, • Manage the RFI process; consisting of the creation of and suggestions on solutions to site issues and tracking them through close out, • Bachelor’s degree in Construction Management, Civil Engineering, Architecture, or related field., • 12+ years of progressive experience in construction leadership, preferably in large-scale commercial, retail, or entertainment developments and hotel experience., • Proven track record of delivering multi-million-dollar projects on time and within budget., • Strong knowledge of construction methodologies, project management tools, and regulatory requirements., • Provide guidance and resolve and conflicts/issues amongst the numerous subcontractors, consultants and vendors, • Ability to identify deficient, unsafe, or non-compliant work and provide resolution, • Demonstrated experience managing projects from start to finish, leading projects through ambiguity, and galvanizing resources from various teams in concerted action, • Proficient with construction, building management and maintenance software preferred, • Endurance and ability to visit and review entire job site, including stairs or other elevated structures, • Ability to read and review blueprints, • Demonstrate accuracy and thoroughness, looking for ways to improve and promote quality, • Apply feedback to improve overall performance, including own performance.

Job Description Our client, a leading provider of two-way radio communication, is searching for a Presale Systems Engineer. This role partners closely with our clients customers and sales team, delivering customer-driven, world-class, leading-edge, end-to-end solutions that rise to the challenges of first responder, government, and non first responder customers, within the State & Local Public Safety, Law Enforcement, School, & Hospital customer base. The Presale Systems Engineer is the overall owner of a solution's technical design, ensuring our client meets their customers' needs. The pre-sale engineer supports the entire ecosystem and concentrates on the following mission-critical technologies at various levels of complexity: Public safety grade mobile voice and data networks, Advanced mobile devices, Public safety mobile broadband networks and devices, Integrated command and control software, Mobile and fixed video solutions. Responsibilities Include: * Customer requirements discovery * Technology strategy development * End-to-end system architecture design * Proposal development * Internal/external technical presentations * Equipment and software solution demos, including configuration and testing You might be the RIGHT person if you are/have: * General knowledge of wireless communications fundamentals (especially Motorola) and voice/data architectures - both public and private (e.g. APCO P25, LTE,) * General knowledge of Cloud, IP networking architecture, protocols and security * Knowledge of RF coverage predictions, microwave design, traffic/capacity modeling, and related toolsets an asset * Bachelor's Degree in Engineering required, preferably Electrical or Computer Engineering * Strong communications skills with the ability to present complex topics to technical and non-technical audiences * Ability to build strong relationships with internal and external stakeholders * Ability to work in the NY/NJ Metro area office a minimum of 3 days a week * Must be a U.S. Citizen Compensation: * Base salary 70-120K BOE * Incentive Bonus Plans * Medical, Dental, Vision benefits * 401K * Paid Holidays & Generous PTO Master Search Solutions is a direct hire recruiting firm that specializes in the New Jersey marketplace. We have over three decades of experience connecting top talent with leading businesses.

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

Job 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 Description Power-Flo Technologies Moonachie has served the needs of the OEM, Industrial, Commercial, and MRO markets in New Jersey since 1934. We are looking for you to join our collaborative team as an outside sales representative. Our Core Values • Our People, • Relationships, • Innovation, • Sustainability, • Growth, • Determination Responsibilities include but are not limited to the following: • Will be expected to engage in a minimum of 20 cold calls per week via phone or in person, • Will be expected to engage in decision maker contact 10 times per week at a minimum, • Will be required to have a minimum of 20 appointments per week, • Will be required to self-source 80% of their own leads, • Estimated amount of regional travel within assigned territory is 4 Days of the week on average, • Identify opportunities at existing and potential new customers within defined geographical areas, • Generate, qualify and manage all sales leads, prospects and new customer accounts, • Will be expected to go out of state for factor training which will include at times air travel, • Manage Supplier relationships. This will include collaboration with suppliers, pricing negotiations with both customers and key suppliers Qualifications include but are not limited to the following: • 3 years of successful outside sales experience in industrial or commercial fields, • Knowledge of Industrial Electrical and Mechanical a plus, • Must have a good Mechanical Aptitude, • 3 years of experience with Preparation of Proposals, Delivering Presentations, Preparing Call Reports and working with Factory Representatives, • Tenacity and inner drive/confidence to successfully overcome objections and outright denials to allow for a successful sale despite the challenging marketplace., • Must be willing to commit the required time to acquire a comprehensive knowledge of the benefits of the company's products and services and to also remain constantly up to date with new developments, • Experience with selection and sizing of electrical controls, variable frequency drives, DC drives, motors, PLC control systems, operators, switches, etc. is helpful., • The successful candidate must be capable of operating with a minimum of supervision, have strong problem-solving skills, strong computer skills and strong verbal and written communication skills., • Must be able to work the hours required to exceed sales goals, address customer concerns etc., • Valid and clean Driver's License Salary Commensurate with Experience ($65,000 - $95,000 draw against commission) Resources provided include but are not limited to the following: Cell phone / Company Vehicle / Laptop Competitive Benefits Package • Health insurance (medical, dental, vision), • EAP, • PTO program and paid holidays, • 401K, • ESOP (Employee Stock Ownership Plan), • Company provided life insurance (after 1 year of employment) Learn more about us here: Follow us on LinkedIn: We are an equal opportunity employer. Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa. Power-Flo Technologies and its subsidiaries participate in the USCIS E-Verify Program to verify that all new hires are authorized to work in the United States. Power-Flo Technologies is a unique Family of Companies consisting of distributors, fabricators, manufacturers and motor and pump repair firms serving the New York metropolitan and New England areas. We are a Master Distributor and Manufacturers Representative with REAL SYSTEMS SOLUTIONS.

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 DescriptionEssential Duties and Responsibilities: • Station master of both the front and back of house, • Effectively train and mentor Crew Members, • Effectively manages the restaurant, including administration of policies and guidelines of the company, ensuring 100% customer satisfaction at all times, • Maintains fast, accurate service, positive guest relations, and ensuring products are consistent with company quality standards, • Ensures Occupational Safety & Health Act, local health and safety codes, and company safety and security policy are met, • Must maintain an “A” health inspection rating at all times, • Controls day-to-day operations by scheduling labor, ordering food and supplies, and developing the restaurant team, • Assists profit & loss, by following cash control/security procedures, maintaining inventory, managing labor, reviewing financial reports, and taking appropriate actions, • Manage Food and Labor Costs, keeping them to the level specified by management., • Conducts performance appraisals, takes disciplinary action, motivates and trains, • Ensures maintenance of equipment, facility, and grounds through the use of a preventative maintenance program, • Ensures food quality at all times, • Ensures a safe working and customer experience environment by facilitating safe work behaviors of the team, • Trains to gain the skills and experience necessary for promotion to General Manager, • Performs day-to-day responsibilities such as using cash register, operating the grill, taking customer orders, etc., as needed, • Other duties and responsibilities as assigned by your supervisor Qualifications - Knowledge, Skills and Abilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. ● Education/Experience: Successful Candidates/Employees of this position must have a High School Diploma or GED. A college or university degree is preferred. In addition, 1-2 years of supervisory experience in either a food service or retail environment is required with responsibility for restaurant/store profit and loss. Experience in providing customer service and a desire to grow in the food industry is strongly preferred. You must have a very hands on management style and be actively involved in all daily functions of the store. • Certifications: A NYC Food Handlers License is required to be considered for this position., • Language Ability: Good communication and interpersonal skills are required. The successful candidate/employee will use communication skills to build an exceptional team, supervise others, give detailed instructions and training, and resolve conflicts. The ability to read and comprehend simple instructions, short correspondences, and memos is necessary. The position also requires the ability to write simple correspondences and the ability to effectively present information one-on-one, in small group situations and to other employees of the organization as well as customers. It also requires the ability to read, analyze, and interpret general business memos, including financial data. This position requires that you are able to proficiently speak, read, and write the English language, • Math Ability: The position requires the ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. It also requires basic business math and accounting skills., • Reasoning Ability: The position requires the ability to solve practical problems and deal with a variety of situations and people. Strong analytical and decision-making skills are needed., • Computer Skills: Basic personal computer literacy is required, with proficiency in Word, Excel, PowerPoint, Internet, and other appropriate software. Must be able to operate cash register., • Supervisory Responsibilities: Supervises Shift Leaders and Crew Members. Requires strong skills and experience in management, delegation, training, creating a positive work environment, and taking disciplinary action, as needed., • Physical Demands: The position’s physical demands require work in a restaurant/kitchen environment with moderate to loud noise levels, varying temperature conditions and possible direct exposure to hazardous substances, such as hot oil. While performing the duties of the job, the employee is regularly required to sit, stand, travel and react quickly to deadlines, sometimes with little notice. The employee is often required to stand for long periods; walk, bend, kneel, and reach with hands boxes or food containers typically weighing 50 pounds or less, without restrictions. May be required to use stepladder. Finger dexterity is required for use of cash register. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. Must be able to travel as needed., • Hospitality: Actively look for ways to help customers, provide as much information as requested. Infer possible customer needs, as it may be their first experience at the restaurant. Knowledge of, quality standards of service, store policies regarding customer interaction, assessment of customer needs and customer satisfaction are all necessary., • Active Listening: Give full attention to what customers are saying, be able to listen to and process the customers’ order without losing track., • Social Perceptiveness: Be aware of customers’ reactions, both verbal and nonverbal, and understand why they are reacting this way. Understand the boundaries of appropriateness., • Integrity-must be honest and possess an immense code of ethics as the cashier is the primary receiver in the cash flow.

Job Description Preview High-volume, family-owned Toyota dealership in Wood-Ridge, NJ seeking an experienced Shop Foreman to lead technician productivity, diagnostics, and development in a modern service operation. About the Dealership We are a family-owned Toyota dealership located in Wood-Ridge, NJ, operating a high-volume service department with approximately 1,500 customer-pay repair orders per month, plus warranty work. We are expanding into a new, state-of-the-art service facility and investing heavily in people, process, and technology. Our shop is staffed with factory-trained and certified technicians, and we are committed to raising efficiency, diagnostic accuracy, and overall technician performance. Position Overview The Shop Foreman / Technical Lead role is designed for an experienced, senior-level technician who is ready to move into a leadership position and focus on guiding, mentoring, and improving the performance of the entire shop. This role is not a full-time wrench-turning position. While hands-on diagnostic assistance may be required when needed, the primary focus is on technical leadership, productivity, accountability, and technician development. Key Responsibilities Technical Leadership & Diagnostics • Serve as the top technical resource for complex diagnostic concerns, • Assist technicians with advanced diagnostic strategy and problem-solving, • Ensure all repairs meet Toyota factory standards and quality expectations Productivity & Efficiency • Monitor technician productivity, efficiency, and workflow, • Identify opportunities to improve shop throughput and utilization, • Work with service management to support fair dispatching and job flow Training, Mentorship & Certification • Mentor and coach technicians to improve skill level and confidence, • Support ASE and Toyota certification advancement, • Help elevate technicians toward expert-level capability Accountability & Quality Control • Hold technicians accountable for proper diagnostic processes and repair quality, • Review comebacks and repeat repairs; implement corrective coaching, • Promote professionalism, consistency, and pride in workmanship Who This Role Is For • Senior or Master-level technicians ready to step into leadership, • Experienced technicians who want to reduce physical wrench-turning, • Professionals who enjoy teaching, coaching, and improving others, • Leaders who command respect through knowledge, not ego Qualifications & Experience • Extensive automotive technician experience (Toyota experience strongly preferred), • Toyota Master Certification strongly preferred, • ASE Master Certification preferred, • Advanced diagnostic expertise, • Proven ability to mentor, coach, and influence other technicians, • Strong communication and leadership skills Compensation & Opportunity • Competitive annual compensation of approximately $90,000–$130,000+, based on experience, certifications, and leadership impact, • Compensation structure may include salary or salary + performance incentives, • Stable, full-time leadership role, • Paid training and continued education, • Opportunity to directly impact shop performance, technician growth, and culture (Compensation will be aligned with experience and the scope of leadership responsibility.) Why Join Us • Family-owned dealership with hands-on leadership, • Brand-new, modern service facility, • High-volume Toyota service department, • Strong commitment to technician training and advancement

Job Description We're located in American Dream Mall! Copy & paste the link below to learn more about our company and the Assistant Manager in Training role! What is Great Big Game Show? In 2023, The Escape Game introduced something entirely new: Great Big Game Show. Great Big Game Show is an immersive, live-hosted experience where guests become contestants, competing in fast-paced mini-games on a soundstage inspired by their favorite TV game shows. Great Big Game Show is expanding rapidly across the United States, with 18 new locations opening in 2026. Description The Assistant Manager works closely with the General Manager to help lead the store across three key areas: 1. Exceeding guest expectations through exceptional hospitality At our core, we are a hospitality company that obsesses over the experience of every single guest. Great Big Game Show locations earn 5.0 Google review ratings by delivering an unexpected level of guest care and hospitality. 2. Upholding training and operational standards Helping ensure consistently excellent games, hosting, and front-of-house execution. 3. Maintaining world-class facilities Supporting cleanliness, organization, and the overall presentation of the store. The Assistant Manager works functional shifts in the store and must be an excellent Guest Experience Specialist (front desk) and Game Show Host. This role is viewed as a future General Manager position and should be filled by someone with a clear passion for Great Big Game Show and a strong desire to step into a General Manager role within the next 6–18 months. You’ll start as an Assistant Manager in Training All Assistant Managers will begin as an Assistant Manager in Training, working 35–40 hours per week. During this period, team members will: • Complete the GBGS training passport, • Master all frontline positions Expectations Leadership & Culture • Serve as a GBGS brand ambassador who exemplifies care for every single guest, • Support the General Manager in leading a team of 12–30 team members of all ages, • Promote and maintain a positive, inclusive, and energetic atmosphere, • Integrate GBGS’s mission, vision, and values throughout the store, • Enthusiastically implement new company initiatives, strategies, policies, and training programs, • Partner with the General Manager to train team members and coach GBGS standards through thoughtful, consistent feedback, • Maintain mastery of all front-of-house roles, including Game Show Host and Guest Experience Specialist, • Assist with operational excellence through upkeep of:, • Apparel and retail products, • Game inventory, • Building maintenance, • Cash control systems, • Shift schedules, • Track and report basic operational and performance data, • Create and distribute the store’s weekly newsletter, • This is a non-exempt role, • Assistant Managers will continue working 4.5–5 functional shifts per week, • You will learn and assist with administrative tasks, but you are not fully responsiblefor:, • Overall store operations, • Managing team relations independently Hiring or exiting team members Exemptions The following responsibilities are not expected at the Assistant Manager level: • Making hiring decisions without the support and approval of the General Manager or Operations leader, • Creating or publishing the store’s team schedule as a regular responsibility, • (Schedules may only be created in rare situations, such as when the General Manager is out of town, and only with approval), • Terminating team members under any circumstance, • All terminations must be handled by the General Manager and/or an HQ leader, • Approving pay changes or raises Job Requirements • High school diploma or equivalent, • College degree preferred, • Leadership experience (6 months or more preferred), • Full embodiment of our mission, vision, and values, • Alignment with the Assistant Manager schedule and flexible availability, including nights, weekends, and holidays, • GBGS must be your sole employer during your time as Assistant Manager Hours • 35–40 hours per week during training, • 40–45 hours per week after full sign-off Uniform & Grooming Standards Beginning 1/7/2025, hair for GBGS store managers must be a naturally occurring color, including shades of black, blonde, brown, gray, or red. Facial hair, including beards and eyebrows, must match natural hair color. Knowledge, Skills, and Abilities • Genuine love for serving others, • Flexibility in a rapidly changing work environment, • Consistently positive attitude, • Ability to manage cash systems, • Strong interpersonal and communication skills, • Ability to positively influence others, • Basic computer skills You Might Be a Great Fit If: • You genuinely enjoy interacting with guests, • You want to grow and appreciate regular feedback and constructive criticism, • You care deeply about excellence and coaching others, • You enjoy a fast-paced, hands-on leadership role, • You’re up for a challenge Company Mission Statement To design and deliver epic interactive experiences for every single guest. Company Values • Passion: We love our guests, our brand, and our games., • Integrity: We endeavor to honor God through hard work, honesty, fairness, and generosity., • Creativity: We are always expanding the boundaries of what is possible., • Teamwork: We can best accomplish our goals by selflessly working together., • Excellence: We are relentless in our pursuit to be the best., • Growth: We believe in expanding our business and developing our team members.

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

The Salvation Army (Eastern) - - Responsibilities: Complete driving routes for pickup and/or drop off of donations; Ensure vehicle safety and report accidents; Perform daily vehicle inspections and maintain cleanliness; Develop and follow daily routes, including scheduling calls and pickups; Assist

OnTrac - 50 Hartz Way - Responsibilities: Unload trailers and sort packages by zip codes; Load trucks for deliveries; Be a team player everyone works together to get the job done!; Be safe! Safety is our first core value.

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

CMA CGM Group - - Responsibilities: Receiving: unload, verify delivery, inspect quality and quantity; Picking: fulfill requisitions and select items for production; Packing: prepare parcels and label items; Releasing: palletize orders and prepare shipment paperwork; Inventory control: count and rec

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

KENCO - - Responsibilities: Pick orders for shipment; Pack orders for shipments by parcel, LTL, and TL carriers; Record product, packaging, and order information on specified forms and records; Affix proper shipping and tracking labels to boxes and pallets; Examine and inspect containers, materials

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

Ferguson - - Responsibilities: Safely operate a stand-up forklift (order selector/cherry picker) to pull and prepare outbound customer orders; Build, wrap, sort, and transport pallets and packages; Use technology like RF devices to sort, scan, and prepare orders; Accurately and timely receive, veri

Directs and coordinates activities of the production shift - plan, organize and control production to ensure that goods are produced efficiently, on time, within budget and to standard. Provide input in establishing production and quality control standards. Provide input to Production Manager on dev

Kellermeyer Bergensons Services - 600 Washington Avenue - Responsibilities: Clean restrooms, break areas, and office areas; Sweep, mop, dust, and remove trash; Ensure walkways are clean and tidy; Clean totes and other items; Follow safety and quality standards.

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

This Jobot Job is hosted by: Kevin Shilney.Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.Salary: $60,000 - $80,000 per year.We are a respected law firm focused on probate, estate planning, business transactions, and civil/commercial litigation.Our

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

Oversee quality control and final punch lists.

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

Dobco is seeking an experienced Project Controls Manager with a strong focus on delay analysis and claims management.