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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 DescriptionSUMMARY Residential program for adult residents which are state inmates classified to a work release/substance abuse program. Staff is accountable to carry out assigned duties relating to the treatment and security of the residence and residents while following establish protocols and procedures approved by NJAC and the NJ Department of Corrections. ESSENTIAL DUTIES AND RESPONSIBILITIES include but are not limited to: • A Licensed Clinical Social Worker professionally applies social work methods and theory to the diagnosis, prevention, and treatment of psychosocial dysfunction, impairment, or disability, including mental, emotional, and behavioral disorders for individuals and groups. The main responsibility of a clinical social worker is to oversee the screening of medical records, conduct interviews and assessments and approve set treatment goals., • He/she shall have primary responsibility for assisting with the coordination of all psychosocial services under the general direction of the Clinical Program Director. In accordance with policies, procedures and protocols established by NJAC standards of practice and other licensing and certificate regulatory agencies requirements., • Responsible for assessing problems and determining appropriate types and methods of treatment, and implementing intervention methodologies; acts as Clinical Program Counselor to staff members with or without professional training; functions in such areas as counseling, substance abuse treatment, and family services., • Provide in-service presentations to staff as needed or required., • Perform short term counseling and crisis intervention as necessary., • Review and evaluate recent psychosocial health research and interpret it to professionals and clients., • Assist in the assessment, planning, arranging, and implementing of psychosocial treatment programs., • Work directly with the Treatment Coordinator to oversee the satisfactory content of education and counseling programs for both individual clients and groups of clients., • Clinically supervise staff social workers seeking clinical social work licensure and social work interns., • Participation in weekly treatment team meetings., • Understands and agrees to support the NJAC Mission and Philosophy Statement. QUALIFICATIONS/Education/Experience: The successful candidate must be successfully cleared by NJDOC and NJAC prior to employment commencement. Must hold a Master’s Degree in social work from an accredited higher learning institution. Experience in clinical social work activities, preferred. Licensed in the State of New Jersey as a licensed clinical social worker. PROFESSIONAL PRACTICE: Practices in a professional manner, collaborates and provides clinical support to other team members. Strives to improve own level of competence through skill development, keeping abreast of social work trends and new developments in care. Knowledgeable of social service procedures, policies, and resources and has the ability to analyze and interpret information to plan appropriate interventions which are compliant with the program’s contract. COMMUNICATION: Communicates in a positive, professional and effective manner with members of the team, clients, and their families (when appropriate) to promote positive client outcomes. Answer inquiries accurately and in a timely manner. Write reports, memos, and evaluations in a complete, clear, concise, and timely manner. Make appropriate use of the computer MIS system in written communication. EMOTIONAL STABLITY: Because Clinical Social Work involves frequently dealing with crises, the profession requires emotional resilience and stability. ATTENDANCE: Regular attendance of 15 hours per week is a requirement of this position. The employee in this position may be required to lift up to 25lbs., stand, walk, reach with arms and hands, climb or balance, use fingers, stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. Individuals must be physically capable of operating the vehicles safely, possess a valid driver's license, must have use of an insured vehicle, and have a satisfactory driving record. Successful background, driving record and criminal record clearances required at hire and/or at random in the future. Employment, educational and credentialing validation also required at hire and upon licensure renewal. Licensure insurance must be provided by the consultant upon hire and at renewal. Computer/TYPING Skills: Strong computer skills including Windows, Microsoft Office, and Agency MIS system. Supervisory Responsibilities: This job has clinical supervisory responsibilities COmPENSATION: $55hr - $60hr ASSOCIATION PHILOSOPHY: All Association employees must be committed to the New Jersey Association on Correction’s philosophy: To promote social justice and human dignity in the policies and institutions which govern offenders and victims of crime through educational, legislative and rehabilitative programs. The New Jersey Association on Correction is an Equal Opportunity/Affirmative Action Employer and will consider all qualified applicants without regard to race, color, religion, sex, national origin, lawful political affiliation or group membership, physical handicap, age, marital status, sexual orientation, prior involvement in the criminal justice system, off the job lawful activities or physical appearance. #ZR Powered by JazzHR xrRqBFKesi

Job DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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

Job Description Soar With Us! Dassault Falcon Jet proudly provides competitive pay, quality benefits, and programs that support your career advancement and personal development. Our benefits are designed to support you and your family’s health and wellbeing, help you secure a strong financial future, and empower you to be successful in all aspects of your work and life. We are committed to finding the best, brightest, and most dedicated individuals in the aviation industry. Our employees are the key to our success. Soar with us! Why Join Us? Impactful Work: Your expertise will directly contribute to the safety and efficiency of our operations. Growth Opportunities: We support your professional development and offer opportunities for advancement. Collaborative Environment: Work with a team of dedicated professionals who are passionate about aviation. Ready to soar with us? Apply now and be a part of our mission to support the world's greatest business jets! JOB SUMMARY: Under the supervision of the Supervisor, FalconCare, the Claim Administrator – Program Analyst is responsible for the day-to-day administration and processing of incoming FalconCare, warranty, and commercial program claims. This includes reviewing maintenance transactions and invoices, checking incoming claims for completeness and accuracy, identifying missing or inconsistent information, preparing documentation for invoice payment, and maintaining KPIs. The role also contributes to data integrity, process efficiency, and visibility into claim activity and program performance. It supports the FalconCare team with claims data cleanup, system updates, and record validation to improve the accuracy, completeness, and reliability of program information. MINIMUM REQUIRED QUALIFICATIONS: • Associate Degree in Business Administration, Finance, Computer Science, Aviation Management, or a related field, or an equivalent combination of education and relevant experience., • Two (2) or more years of experience in claims administration, business analysis, program administration, or a related operational support function, preferably in aviation., • Two years of aviation technical experience in either a technical or administrative role, • Proficiency in Microsoft Excel (ie Filters, VLOOKUP’s) and other Microsoft Office applications, with the ability to organize, analyze, and present data effectively., • Strong attention to detail, organizational skills, and the ability to manage multiple priorities while maintaining accuracy and meeting deadlines., • Strong written and verbal communication skills, with the ability to work effectively across departments and with external partners. ADDITIONAL DESIRED QUALIFICATIONS: • Experience using SAP or similar enterprise systems for transaction processing, reporting, or record management. PHYSICAL DEMANDS AND WORKING ENVIRONMENT: • Office Environment, • Occasional travel may be needed, • Occasional overtime and weekend work to meet deadlines PRINCIPAL DUTIES/RESPONSIBILITIES (ESSENTIAL FUNCTIONS): • Review all incoming claims for completeness and accuracy, identify missing or inconsistent information, and coordinate with internal teams or external service providers to obtain required documentation and resolve discrepancies., • Read through submitted maintenance task claims and look for missing relevant technical information., • Coordinate with internal departments, service centers, and other stakeholders to resolve claim-related questions, support program administration, and ensure timely follow-up on outstanding items., • Prepare, validate, and process final Service Center invoices for payment., • Organize, scan, and route claim and invoice documentation for DFJ Accounting processing, maintaining complete and accurate records in accordance with internal documentation and audit requirements., • Monitor claim activity and expense trends, prepare recurring and ad hoc analyses, and support management with reporting that helps identify issues, improve workflows, and inform operational decision-making., • Update work instructions as needed. NON-PRINCIPAL DUTIES/RESPONSIBILITIES (NON-ESSENTIAL FUNCTIONS): • Support special projects, process improvement initiatives, audits, and related assignments as directed by management. Compensation and Benefits The compensation for this position typically falls between $70,000 to $90,000 per year. This position is not eligible for overtime. Note: the final compensation offered to a successful candidate will depend on several factors that may include but are not limited to the type and years of relevant experience, Falcon-specific experience, relevant education/certifications, geographic location, and shift. Our total compensation package also offers comprehensive healthcare coverage (Medical/Prescription, Dental, Vision), HSA and FSA options, 401k Plan with Company Match, Life Insurance, Disability Benefits, Supplemental Insurance, Group Legal, Paid Time Off, Tuition Reimbursement, Employee Discounts and much more. We are committed to finding the best, brightest and most dedicated individuals in the aviation industry. Our employees are the key to our success. Soar with us.

Job Description Company Overview: NRS is a leading provider of transportation & supply chain management services, and a family-owned and operated company that has been providing smart logistics solutions for the world's leading retailers and manufacturers for 70+ years. Whether it’s NRT, Keystone, Keystone Fresh, or Keystone Capacity, our innovative energy drives us towards new and valuable solutions for our clients, even as we continuously grow and strengthen our network. We are dedicated to creating a culture that empowers the individual and offers our associates the opportunity to apply their unique skill to the challenges facing our clients. In the office, the warehouse, or on the road, it is this commitment to our innovative spirit that unites us in common mission to push boundaries in the logistics industry. Job Overview: This is currently an individual-contributor role with a clear path to building and leading a team of TMS analysts and/or driver technology support staff as the program matures. The ideal candidate brings direct transportation experiences such as dispatch, load planning, or carrier management along with the technical fluency to translate between IT and the business and advocate for business needs within IT. Duties and responsibilities: Platform Selection & Solution Design • Act as the primary liaison between IT and transportation operations, customers, carriers, and executive stakeholders to define business and functional requirements for a new TMS., • Lead or co-lead vendor evaluation and selection, including demos, reference checks, fit/gap analysis, and total-cost-of-ownership comparisons., • Translate operational workflows (load planning/optimization, dispatch and scheduling, carrier/broker sourcing and tendering, rating and quoting, track-and-trace, appointment/dock scheduling, freight audit and payment, driver settlements) into system configuration and design decisions. Implementation & Customer/Carrier Migration • Own the implementation project plan, budget, and timeline; manage the implementation partner/systems integrator where one is engaged., • Design and execute the migration strategy for customers, carriers, and drivers — sequencing, cutover planning, data migration/validation, parallel-run testing, and rollback plans — in partnership with operations leadership., • Coordinate user acceptance testing, training, and documentation for dispatch, operations, and driver-facing teams. Integrations • Inventory and prioritize every existing integration between the legacy TMS and downstream/upstream systems (WMS, CMS, ERP/accounting, EDI with customers and carriers, telematics/ELD providers, fuel card and IFTA reporting systems, load boards, factoring, customer visibility portals, etc.)., • Define integration requirements and acceptance criteria; work with internal engineers and/or vendor professional services to rebuild each interface on the new platform., • Establish testing and monitoring standards so integration issues (e.g., missed EDI transactions, rating errors, telematics gaps) are caught after they affect customers or drivers. Ongoing Product Ownership & Support • Serve as the permanent product owner for the TMS post go-live: maintain the roadmap, prioritize enhancement requests, and manage the relationship with the software vendor., • Own production support escalations for the TMS, working with IT and the vendor to resolve issues and minimize disruption to dispatch and customer service., • Continuously evaluate new TMS functionality (e.g., load optimization, dynamic pricing, automated tendering) against business needs and lead rollout of upgrades and new features. Mobile & In-Cab Technology Management • Own the lifecycle of TMS-connected hardware and driver-facing technology: ELDs, in-cab tablets/mobile computers, telematics/GPS units, and related driver mobile apps., • Manage procurement, deployment, configuration, maintenance, and vendor relationships for this device and telematics fleet., • Ensure devices and integrations stay current with regulatory requirements (e.g., ELD mandate, HOS rules). Team Leadership • Operate as a hands-on individual contributor during selection and early implementation., • Build the business case for, and eventually hire and lead, a team that may include TMS analysts and driver technology support staff., • Support and promote the company values, culture, and HR processes, • Establish and track KPIs, metrics, and reporting for team activities, • Recruit, reward, and recognize employees, • Provide the necessary training opportunities, tools, and resources to ensure team success, • Provide clear direction in weekly team checkpoints, • Manage frequent performance feedback, • Establish a training & adoption plan for process changes across IT and business stakeholders. Qualifications: • 5+ years of experience working directly with a Transportation Management System, including meaningful time in trucking/transportation operations (dispatch, carrier management, or brokerage), not solely IT/systems-side experience., • Demonstrated experience with at least one full TMS implementation or major platform migration, ideally in a multi-customer 3PL or asset/non-asset trucking environment., • Working knowledge of the integration landscape around a TMS (WMS, EDI, ERP, telematics/ELD, fuel/IFTA, load boards) and enough technical fluency to scope and validate integration work with engineers., • Experience managing driver-facing/mobile technology such as ELDs, in-cab tablets, or telematics platforms., • Strong project management skills — able to run a multi-workstream implementation with hard deadlines and multiple customer and carrier stakeholders., • Excellent communication skills and the credibility to act as a trusted translator between operations/customers and IT/engineering., • Willingness and ability to travel to terminals and customer sites as needed (est. 10%). Preferred / Nice-to-Have • Direct experience with one or more major TMS platforms (e.g., McLeod, TMW/Trimble, MercuryGate, Oracle Transportation Management, Aljex, Revenova, or similar)., • Prior experience in a 3PL or trucking carrier/brokerage specifically, including multi-tenant/multi-customer configuration considerations., • Experience with telematics/ELD providers (e.g., Samsara, Platform Science, Omnitracs) and their integration into a TMS., • Familiarity with EDI standards (204, 210, 214, 990) common in transportation and freight audit/pay processes., • Experience standing up or scaling a team (analysts, engineers, or driver technology support staff). Physical Demands: • This position may require travel to various company locations on the East and West Coast., • Extended Sitting: Primarily desk-based with prolonged computer use., • Computer Use: Frequent operation of computers and office equipment, requiring manual dexterity., • Eye Strain and Repetitive Motion: Risk from continuous screen use and repetitive tasks like typing., • Office Navigation: Light walking and standing for meetings and tasks within the office., • Light Lifting: Occasional handling of objects up to 20 pounds. EEO Statement: NRS is an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #NRSIND

Job DescriptionCompany Description STS Aerospace is a leading aerospace manufacturing and engineering company specializing in fluid conveyance solutions for commercial aviation, defense, and space applications. The company designs and manufactures high-performance rigid tubing, flexible hose assemblies, and custom-engineered fluid transfer systems used in critical aerospace platforms worldwide. With a strong commitment to quality, innovation, and customer service, STS Aerospace delivers reliable solutions that support the safety and performance of mission-critical aerospace systems. Job Description The Aerospace Kinetic ERP Developer / Technical Analyst serves as a key cross-functional technical resource for the Epicor ERP program (Kinetic) across Aerospace operations. The role is responsible for designing, building, testing, and supporting technical ERP solutions that enable approved business process and configuration decisions led by Core Team members and implementation partners. This position works across functions and domains to translate business and functional requirements into technical objects and solutions within Kinetic and related capabilities. The role is expected to contribute heavily to hands-on development and technical problem solving while also partnering effectively with Core Team members, IT, and external consultants to support a scalable, supportable ERP solution. Over time, the role is expected to deepen technical expertise in Epicor Kinetic and related tools, support future Aerospace site rollouts, and provide ongoing post-go-live support and enhancement capability. This role is intended to be a strong technical contributor during implementation and stabilization, while also building long-term internal capability for post-go-live support and future Aerospace rollout needs. The position offers growth into deeper Kinetic technical ownership over time without requiring the candidate to arrive as a fully formed Kinetic expert on day one. Responsibilities: Technical ERP Development & Build • Design, develop, configure, test, and support technical ERP solutions in Epicor Kinetic based on approved business requirements and Core Team direction., • Build and maintain ERP-related technical objects such as:, • BAQs, • Dashboards, • Reports, • Application Studio customizations, • Functions / BPM / workflow automation, • Interfaces and integration touchpoints, • Conversion and data-load technical components, • Other approved technical enhancements, • Troubleshoot and resolve technical issues related to Kinetic development objects, integrations, reporting, and related solution components., • Support development, maintenance, and continuous improvement of reusable technical patterns, standards, and documentation. Core Team Technical Partnership • Partner with Core Team members across functions and domains to translate approved process, configuration, and business-rule decisions into technical ERP solutions., • Participate in workshops and working sessions to understand requirements, identify technical dependencies, and clarify design impacts., • Act as a technical liaison across Core Team members, IT, and implementation partners to support solution design, issue resolution, and technical delivery., • Contribute technical input to development object specifications, solution options, and implementation approaches. Testing, Conversion, and Technical Readiness Support • Own unit and component testing for technical development objects prior to formal test cycles., • Support integrated testing, data validation, and user acceptance testing activities led by Core Team members by resolving defects, validating technical objects, and assisting with test issue analysis., • Support technical aspects of data conversion and migration activities, including mapping validation, load readiness, reconciliation support, and defect resolution, in partnership with Core Team and data-focused resources., • Support technical defect triage, issue analysis, and resolution coordination during implementation, go-live, and post-go-live stabilization., • Support application security, roles, and controls configuration as directed by designated owners, including technical setup assistance and preliminary validation. Documentation, Standards, and Knowledge Transfer • Contribute to technical documentation for development objects, support procedures, release notes, and solution standards., • Help establish and maintain practical technical standards for Kinetic development, supportability, and solution consistency., • Provide technical knowledge transfer to internal support resources and contribute to technical readiness for future Aerospace rollouts., • Contribute to a supportable long-term solution by favoring standard capabilities where practical and escalating gaps through the appropriate channels. Scope Clarification / Working Model This role is a technical enablement and build role that works in close partnership with function/domain Core Team members. Core Team members are expected to lead business-side responsibilities such as: • future-state process decisions, • process mapping ownership, • functional configuration ownership, • business test scripts and UAT leadership, • data cleansing ownership, • training, SOPs, and business adoption, • cutover business readiness Occasional travel to Aerospace sites, primarily within the U.S., may be required to support implementation, testing, go-live, stabilization, and future rollout activities. Limited international travel may be possible based on business needs. Qualifications Required: • Bachelor's degree in Information Systems, Computer Science, Engineering, Business, or a related field (or equivalent professional experience), • 5+ years of hands-on experience in ERP-related technical analyst, application analyst, developer, or similar roles, • Demonstrated expertise building or supporting ERP technical objects such as reports, dashboards, forms/UI customizations, workflows, automation, interfaces, or data conversion components, • Strong ability to analyze business requirements and translate them into effective technical solutions, • Proven experience supporting ERP implementations, upgrades, rollouts, or major enhancement efforts, • Excellent analytical, troubleshooting, and problem-solving skills with meticulous attention to detail, • Strong documentation and technical writing abilities, • Effective communication and collaboration skills with the ability to work seamlessly across technical and non-technical teams, • Proficiency with SQL or database query languages, • Experience with version control and source control systems Preferred: • Hands-on experience with Epicor Kinetic platform, • Experience in manufacturing and/or aerospace environments, • Knowledge of business process modeling and optimization, • Experience with testing methodologies and quality assurance practices, • Familiarity with system integration and API development, • Background supporting multiple ERP system implementations or upgrades Additional Information All your information will be kept confidential according to EEO guidelines. We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity. At no time during the hiring process will Smiths Group, nor any of our recruitment partners ever request payment to enable participation – including, but not limited to, interviews or testing. Avoid fraudulent requests by applying jobs directly through our career’s website (Careers - Smiths Group plc)

Job DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to conduct investigation and CAPA processes., • Conduct investigation and identify true root cause using appropriate tools., • Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates., • Reviews and approves investigations and CAPAs when required;, • Collaborate with cross functional department to develop and track CAPA plans., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Other duties as assigned.REQUIREMENTS, • B.S in biological sciences or other relevant field of study., • Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Competencies/Candidate Profile, • Relevant computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to work in a team-oriented environment., • Must be able to work occasional weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-o-Vator available for use. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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

Job Description Job Summary: Administers implements and maintains the company's Quality Management System to assure products and services supplied, manufactured or offered by the organization meet or exceed customer expectations. Interaction is with all levels of the organization. Plans, coordinates and directs quality assurance and procurement activities by performing the following duties personally or through subordinate staff. Primary Responsibilities: • Participates in company strategic planning in the development and validation of quality assurance goals., • Maintains the company's quality system policies and procedures in compliance with company policy and ISO 9000 at all document levels including development, approval, distribution and control. Interacts with senior management on quality policy issues and the assignment of authorities and responsibilities relative to the quality management system., • Maintains the company's corrective and preventive action process which includes, corrective or preventive action issuance for nonconformity or process improvement, facilitation of problem solving tools and techniques, closure and follow-up verification for suitability and effectiveness of actions taken., • Maintains the company's quality audit process which includes, auditor selection, training and qualification, audit scheduling, review and approval of audit reports, issuance of corrective actions for audit findings and follow-up audits to determine suitability and effectiveness of actions taken., • Develops, implements, and maintains standardized processes/procedures for inspection, testing, and evaluation of CAD Products., • Prepares product certification and reports as required by customer., • Maintains the company's process for control and calibration of all inspection, measurement and test equipment and tooling., • Interacts with customers, suppliers, quality assurance representatives and company personnel to resolve quality related issues., • Maintains the company's procurement quality assurance activities which include, supplier relations quality policy, supplier quality assurance program requirements, coordination of supplier product/process qualification activities, purchase order review / approval, supplier rating system and supplier corrective and preventive action process., • Prepares training material and conducts training sessions on quality system activities including new employee orientation., • Performs measurement, analysis and reporting for internal/external nonconformity, on-time delivery and customer satisfaction., • Prepares agenda / reports and participates in the company's quality system management review process., • Follows procedures as defined by CAD policies, procedures, and ISO9001:2000 requirements. Maintains confidentiality of all information processed. Performs related duties as assigned. Regular and consistent attendance is required. Essential Skills: Subject Matter Understanding. Analytical. Computer Applications. Presentation. Project Management. Delegation. Critical Thinking. Problem Solving. Decision Making. Relationship Building. Job Qualifications: Required: Bachelors degree in engineering or related field or an equivalent combination of education and experience. Five years post degree experience in quality engineering activities. Familiarity with ISO9000 and other quality standards. . Must pass the ATF Background check. Preferred: ASQC CQM certification or five plus years progressive experience in quality engineering. Working knowledge of Microsoft Office Suite.

Job Description Position Title: Molecular Technologist Reports to: Molecular Supervisor Position Summary: The Molecular Technologist is responsible for performing all aspects of testing in a clinical molecular laboratory. The technologist performs complex technical work involving molecular analysis. The technologist performs extensive and complex steps requiring manual manipulation and pipetting, close monitoring and control, evaluation of data and careful, accurate work. They assist supervisors in the development of new technologies and participates in documenting and implementing quality control and procedures. Perform all aspects of patient care in a laboratory environment that optimizes patient safety. Demonstrate ability to function competently according to established company and departmental policies and procedures. Specific duties include Quality Control and Calibration review, facilitating the training schedule and competencies for the department staff, managing the Proficiency testing for the department, and other duties, as assigned by the department Supervisor. Position Responsibilities: To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each responsibility competently. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the responsibility. Responsibilities include but are not necessarily limited to the following: Evaluate specimens received by the department and organize workflow to provide optimum efficiency of testing and turnaround time of results. Extract, denature and purify DNA from assorted specimen types Perform PCR, hybridization, and genetic sequencing methods Evaluate results to determine interference, inhibition, or other problems that arise during extraction, amplification, or sequencing of DNA Perform quality control, validation, and other quality activities to verify performance of clinical assays Maintain equipment by performing assigned maintenance activities and troubleshoot unexpected problems with equipment Evaluate inventory of supplies and reagents and communicate order needs Operate complex equipment and computer programs related to equipment and LIS system Maintain records of test results and archives of data Perform proficiency testing to maintain compliance with regulatory agencies Assist department in writing and maintaining standard operating procedures for clinical assays. Document knowledge by reviewing and signing SOPs annually Assists the department Supervisor with managing the technical operations of their department which may also include staff supervision. Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problem or immediately notify Laboratory Management Understand and comply with all company policies/procedures and regulatory standards Demonstrate the ability to be flexible, organized and function under stressful situations. Perform all responsibilities independently with no direct supervision required Perform all other duties as assigned Competencies: Knowledge of medical laboratory principles, standards, applications, and tests Knowledge of medical laboratory safety, cleanliness and infection control policies and regulations Knowledge of medical laboratory equipment uses and maintenance Ability to maintain confidentiality and comply with all HIPAA regulations Strong interpersonal skills and professional demeanor Ability to communicate effectively verbally and in writing Critical thinking with efficient and effective problem-solving skills. Ability to work well in a team environment that promotes inclusiveness and communication among team members. Education and Experience: Bachelor of Arts/Science Degree in Medical Technology, Molecular, Chemistry, Biology, or related Life Science Certification and Licensure: MT ASCP preferred Work Environment: Environmentally controlled laboratory environment Fast paced environment with occasional high pressure or emergent situations Possible exposure to infectious specimens, communicable diseases, toxic substances, and other conditions common to a laboratory environment Required to wear Personal Protective Equipment (PPE) as appropriate such as lab coats, face shields, gloves, and masks Physical Demands: Frequent standing, walking, grasping, carrying, and speaking Occasional sitting, reaching, bending, and stooping Lifting, carrying, pushing, and pulling up to 50 pounds, with assistance if needed Frequent use of computer, keyboard, phone, and copy and fax machine as needed

Job Description Infor ERP Project Manager / Systems Integration Manager We are seeking an experienced Infor ERP Project Manager / Systems Integration Manager to lead the implementation, integration, enhancement, and ongoing support of our Infor ERP platform. This role is responsible for connecting existing databases and business applications with Infor, developing secure data streams, overseeing system maintenance, and implementing new software solutions that improve business operations. The ideal candidate is a technical project manager with strong ERP implementation experience, systems integration expertise, database knowledge, and the ability to collaborate with stakeholders across all departments to deliver reliable, scalable business technology solutions. • ERP Project Management, • Lead the implementation, configuration, enhancement, and ongoing administration of the Enfor ERP system., • Manage all phases of ERP projects, including planning, scheduling, budgeting, testing, deployment, and post-implementation support., • Coordinate project timelines, resources, vendors, and internal stakeholders., • Binary codes to create data streams, • Identify project risks and develop mitigation strategies to ensure successful project delivery., • Systems Integration, • Design, develop, and maintain integrations between Infor and existing databases, enterprise software, and third-party applications., • Bridge legacy systems and new applications into the Infor environment while maintaining data integrity and system performance., • Develop and maintain APIs, middleware, ETL processes, and automated data synchronization., • Create, manage, and optimize binary code interfaces and data streams for secure, accurate, and efficient system communications., • Analyze system architecture and develop scalable integration solutions., • Database & Data Management, • Develop and maintain SQL queries, database connections, and data mapping processes., • Oversee data migration, validation, synchronization, and quality assurance., • Monitor data flow between systems and resolve interface or integration issues., • Ensure the security, accuracy, and integrity of enterprise data., • Application Development & Support, • Evaluate business needs and recommend new software applications that integrate with Infor., • Manage implementation of new business applications and software enhancements., • Coordinate software upgrades, patches, testing, and production deployments., • Provide ongoing maintenance and technical support for Enfor and integrated applications., • Troubleshoot system issues and coordinate resolutions with vendors and internal IT teams., • Collaborate with department leaders to identify opportunities for process improvements and automation., • Develop system documentation, workflow diagrams, technical specifications, and integration documentation., • Lead User Acceptance Testing (UAT) and production releases., • Train end users on system functionality and best practices., • Insure compliance with company security standards and technology policies. Required Qualifications • Bachelor's degree in Information Technology, Computer Science, Information Systems, Business Administration, or a related field., • Five (5) or more years of ERP implementation and project management experience., • Experience implementing or supporting Enfor ERP or similar ERP platforms., • Strong knowledge of systems integration, APIs, ETL processes, middleware, and enterprise software architecture., • Experience with SQL databases, database administration, and data migration., • Experience creating and managing secure data streams, binary data interfaces, and automated system integrations., • Strong understanding of application programming concepts and enterprise integration technologies., • Experience managing multiple technology projects simultaneously., • Excellent analytical, troubleshooting, communication, and leadership skills., • Preferred Qualifications, • Project Management Professional (PMP) certification., • Experience with cloud-based enterprise applications., • Knowledge of REST APIs, XML, JSON, EDI, and web services., • Experience with business intelligence and reporting tools., • Experience with manufacturing, finance, inventory, supply chain, payroll, or HR systems., • Familiarity with cybersecurity best practices and data governance.

Job DescriptionSalary: 110,000-145,000 Company Overview Montana Construction Inc. is a family-owned heavy construction company specializing in sewer, water, bridge, and emergency services for municipalities, utility authorities, and private entities across New Jersey, New York, and Pennsylvania. We pride ourselves on delivering efficient, dependable, and quality service to every client. As we continue to grow, the Project Data & Technology Integration Manager plays a key role in connecting our business operations, project teams, and technology systems to support that growth. Position Summary We are seeking a highly organized and technology-driven Project Data & Technology Integration Manager to lead and coordinate data, systems, and process integration initiatives across the organization. This role combines project management responsibilities with operational process improvement and technology integration oversight to ensure successful execution of business and IT initiatives. Reporting to the Director of IT, the ideal candidate will bridge the gap between business operations, project teams, and technology solutions by managing implementation efforts, improving workflows, coordinating stakeholders, and ensuring accurate data integration across systems. Key Responsibilities Project & Program Management • Lead cross-functional technology and process integration projects from planning through execution and completion., • Develop project plans, timelines, milestones, risk assessments, and status reporting., • Coordinate internal teams, vendors, consultants, and stakeholders to ensure project success., • Track deliverables, dependencies, and resource allocation across multiple initiatives., • Facilitate meetings, document action items, and provide executive-level project updates., • Assist with change management, user adoption, and training efforts. Data & Technology Integration • Manage integration of business systems, applications, and operational workflows., • Coordinate data migration, validation, and synchronization efforts between platforms., • Work closely with IT, operations, and business departments to identify integration requirements., • Support implementation of automation, reporting, and workflow optimization initiatives., • Ensure data accuracy, consistency, and process standardization across systems., • Develop and document standard operating procedures (SOPs), workflows, and integration processes., • Perform additional duties and special projects as assigned by the Director of IT. Required Qualifications • Bachelors degree in Information Technology, Business Administration, Project Management, or a related field preferred., • 710 years of experience in project management, technology integration, operations, or related roles., • Strong understanding of business systems, data management, and process improvement methodologies., • Experience coordinating software implementations, system migrations, or operational technology projects., • Proficiency with project management tools and collaboration platforms., • Excellent organizational, analytical, and communication skills., • Ability to manage multiple projects and priorities simultaneously. Preferred Skills • Experience with AI technologies, cloud platforms, or workflow automation tools., • Familiarity with data integration concepts, APIs, and reporting tools., • Knowledge of IT infrastructure, SaaS platforms, and operational systems., • Project management certification (PMP, CAPM, Agile, Scrum, etc.) is a plus. Key Competencies • Project Coordination, • Process Improvement, • Technology Integration, • Data Management, • Stakeholder Communication, • Problem Solving, • Organizational Leadership, • Cross-Functional Collaboration Work Environment / Conditions • Office-based role at Montana Constructions corporate headquarters with regular interaction with IT, operations, and business stakeholders., • Fast-paced environment requiring the ability to manage multiple concurrent projects and competing priorities., • Standard business hours, Monday through Friday, with additional hours required during active implementation or migration periods. Physical Requirements • Ability to sit for extended periods while working at a computer workstation., • Frequent use of keyboard, mouse, and other standard office equipment., • Occasional standing, walking, and reaching within the office environment., • Ability to lift and carry items up to 15 pounds occasionally (e.g., files, office supplies). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this role, in accordance with the Americans with Disabilities Act (ADA) and applicable state laws. Compensation & Benefits • Competitive salary commensurate with experience and qualifications., • Comprehensive health, dental, and vision insurance plans., • 401(k) plan with company matching contributions., • Paid time off (PTO) and paid holidays. Pre-Employment Requirements • Subject to pre-employment background check., • Subject to pre-employment drug screening. Montana Construction Inc. is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.

Job Description Company Overview: NRS is a leading provider of transportation & supply chain management services, and a family-owned and operated company that has been providing smart logistics solutions for the world's leading retailers and manufacturers for 70+ years. Whether it’s NRT, Keystone, Keystone Fresh, or Keystone Capacity, our innovative energy drives us towards new and valuable solutions for our clients, even as we continuously grow and strengthen our network. We are dedicated to creating a culture that empowers the individual and offers our associates the opportunity to apply their unique skill to the challenges facing our clients. In the office, the warehouse, or on the road, it is this commitment to our innovative spirit that unites us in common mission to push boundaries in the logistics industry. Job Overview: This is currently an individual-contributor role with a clear path to building and leading a team of WMS analysts, and/or device support technicians as the program matures. The ideal candidate brings direct warehouse operations experience — they've used a WMS on the floor, not just configured one from behind a desk — along with the technical fluency to translate between IT and the business and advocate for business's needs within IT. Duties and responsibilities: Platform Selection & Solution Design • Act as the primary liaison between IT and warehouse operations, customers, and executive stakeholders to define business and functional requirements for the new WMS., • Lead or co-lead vendor evaluation and selection, including demos, reference checks, fit/gap analysis, and total-cost-of-ownership comparisons., • Translate operational workflows (receiving, putaway, inventory management, wave/pick/pack, replenishment, cycle counting, shipping, yard management, billing) into system configuration and design decisions. Implementation & Customer Migration • Own the implementation project plan, budget, and timeline; manage the implementation partner/systems integrator where one is engaged., • Design and execute the customer migration strategy — sequencing, cutover planning, data migration/validation, parallel-run testing, and rollback plans — in partnership with operations leadership., • Coordinate user acceptance testing, training, and documentation for warehouse and customer-facing teams. Integrations • Inventory and prioritize every existing integration between the legacy WMS and downstream/upstream systems (TMS, order management, EDI, customer portals, billing/invoicing, labor management, ERP, BI/reporting, etc.)., • Define integration requirements and acceptance criteria; work with internal engineers and/or vendor professional services to rebuild each interface on the new platform., • Establish testing and monitoring standards so integration issues are caught after they affect customers. Ongoing Product Ownership & Support • Serve as the permanent product owner for the WMS post go-live: maintain the roadmap, prioritize enhancement requests, and manage the relationship with the software vendor., • Own production support escalations for the WMS, working with IT and the vendor to resolve issues and minimize warehouse downtime., • Continuously evaluate new WMS functionality against business needs and lead rollout of upgrades and new features. Device & Hardware Fleet Management • Own the lifecycle of WMS-connected hardware across all warehouse sites: RF scan guns, mobile/label printers, conveyor and sortation system controls, and related peripherals., • Manage procurement, deployment, configuration, maintenance, and vendor/repair relationships for this device fleet., • Partner with warehouse operations to right-size device counts and standards as sites are migrated to the new WMS. Team Leadership • Operate as a hands-on individual contributor during selection and early implementation., • Build the business case for, and eventually hire and lead, a team that may include WMS analysts and device/hardware support technicians., • Support and promote the company values, culture, and HR processes, • Establish and track KPIs, metrics, and reporting for team activities, • Recruit, reward, and recognize employees, • Provide the necessary training opportunities, tools, and resources to ensure team success, • Provide clear direction in weekly team checkpoints, • Manage frequent performance feedback, • Establish a training & adoption plan for process changes across IT and business stakeholders. Qualifications: Required • 7+ years of experience working directly with a Warehouse Management System, including meaningful time in warehouse/3PL operations (not solely IT/systems-side experience)., • Demonstrated experience with at least one full WMS implementation or major platform migration, ideally in a multi-customer 3PL or multi-site distribution environment., • Working knowledge of the integration landscape around a WMS (TMS, EDI, ERP, order management, billing) and enough technical fluency to scope and validate integration work with engineers., • Experience managing warehouse hardware such as RF scanners, mobile printers, or conveyor/sortation controls., • Strong project management skills — able to run a multi-workstream implementation with hard deadlines and multiple customer stakeholders., • Excellent communication skills and the credibility to act as a trusted translator between operations/customers and IT/engineering., • Willingness and ability to travel to warehouse and customer sites as needed (est. 30–40%). Preferred / Nice-to-Have • Direct experience with one or more major WMS platforms (e.g., Manhattan, Blue Yonder, Synapse, HighJump/Körber, SnapFulfil, or similar)., • Prior experience in a 3PL specifically, including multi-tenant/multi-customer configuration considerations., • Experience standing up or scaling a team (analysts, engineers, or device support technicians)., • Familiarity with EDI standards and common carrier/customer integration patterns in trucking and warehousing. Physical Demands: • This position may require travel to various company locations on the East and West Coast., • Extended Sitting: Primarily desk-based with prolonged computer use., • Computer Use: Frequent operation of computers and office equipment, requiring manual dexterity., • Eye Strain and Repetitive Motion: Risk from continuous screen use and repetitive tasks like typing., • Office Navigation: Light walking and standing for meetings and tasks within the office., • Light Lifting: Occasional handling of objects up to 20 pounds. EEO Statement: NRS is an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #NRSIND