Iso jobs in Passaic, New JerseyCreate job alerts

Job DescriptionManufacturing Associate II Allendale, NJ Lynkx Staffing specializes in placing Biotechnology, Pharmaceutical, Medical Devices, IT & Human Resources professionals in New Jersey. Under the supervision of the Associate Manager, the Manufacturing Associate II processes, cultures, cryopreserves and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance to facility GLP, GTP and GMP practices. Facility and personnel specific responsibilities will be regulated by company's policies or client procedures being performed at each Cellular Production Facility. The ideal candidate must have a collaborative and inquisitive nature, must possess excellent organizational and verbal and written communication skills and be flexible in their working hours. • Performs any and all required processing and manipulation required to produce and assess safe and efficacious products, • Proficiently functions within an ISO Class 7 and 6 clean room environments, ensuring personal and product safety, • Consistently produce a high level of documentation accuracy and clarity, • Performs cryopreservation of products using DMSO base solutions and controlled-rate freezers, • Proficiently operate and maintain equipment according to designed procedures. Assigned responsibilities could include but is not limited to COBE 2991 cell washer, Clinimacs cell separator, Elultra cell separator, controlled- rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, CO2 incubators, liquid nitrogen freezers, microscopes, pipets, wave bioreactors, refrigerators, ultra- cold freezers, water baths, tube sealers, dry shippers, centrifuges, sterile connection devices, • Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints, • Participating in clinical trial support and studies, may include but not limited to sample preparation, sample shipping, media and reagent preparation., • Thawing and/or washing cryopreserved hematopoietic cell products either at the Clinical Site or in the facility as specified by standard operating procedures, • Performing facility and equipment duties such as periodic maintenance, preventive maintenance, for applicable methods and equipment, reporting facility and equipment problems to Assistance Manager, trouble-shooting facility and equipment problems as specified in standard operating procedures, • Notifying Management of any deviation that may occur during processing or during equipment maintenance., • Applies knowledge of processing principles and techniques to make good judgement and appropriate decisions, • Performs investigations for deviations and complete deviations and CAPA’s (Corrective and Preventive Actions) in a timely manner, • Supports technology transfers into GMP manufacturing operations, • Participate in the on-call programREQUIREMENTS, • BA/BS or Associate's Degree in a biologics or related field preferred, • 2-4 + years of applicable experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing, • Current Medical Technologist license or equivalent is a plus, • Aseptic/cell processing and clean room experience preferred, • Demonstrates tact and courtesy in dealing with others, • Strong work ethic, methodical approach to new challenges, • GLP and GMP experience a plus, • Must be able to work independently and with minimal supervision, • Able to work in fast paced environment at times under pressure and with tight deadlines, • Excellent organizational skills and attention to detail, • Good verbal and written communication skills, • Strong team-oriented interpersonal skills are essential, • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work a flexible schedule that may include nights, weekends and/or holidays, • Training Required; GMP, Gowning training/qualification, Aseptic process qualification (personal media fill), • 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 companyWorking EnvironmentMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work in the cleanroom environment for extended period of timeMust have the ability to work with specialized equipmentMust 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 DescriptionDescription: The Driver role performs dedicated pick-up and delivery in the local area for assigned routes. This position requires a Class A license, 2 years minimum experience operating a tractor/trailer (53' dry van, High Cube, Flatbed), clean DMV (no major at-fault accidents or speeding in commercial vehicles) and current medical card, city driving experience in all weather conditions. Material handling is required. This is a fast-paced, dedicated on-time delivery environment - a sense of urgency and commitment to customer service is a must. Requirements: Responsibilities and Duties: • Keep paperwork and cargo supply organized to facilitate a smooth workflow., • Responsible for occasional route coverage to absence of other drivers., • Load, secure, inspect and fuel before and as necessary during your shift., • Immediately report any problems during route to immediate supervisor., • Assist in helping other drivers during load outs to maintain a safe work environment., • Keep assigned Truck and work area at Terminal organized and clean for safety and efficiency., • Tarp, Strap and Chain (when required) all loads to Federal Cargo Requirements., • Sense of urgency and commitment to customer service., • Ensures that safety requirements are followed by drivers at all times., • Advanced knowledge of DOT rules and regulations, • Route planning for optimal driver and vehicle utilization., • Maintains clear and accurate records and logs., • High school diploma or equivalent, • Strong math & writing skills, • Customer and Quality focused, • Intermediate computer skills, • 2-4 years of experience in the transportation field or any other related industry, • LEAN understanding with the ability to fully execute 5s and 7s, • Understanding of logistics, shipping, receiving and transportation, • Excellent time management, • Great communication and soft skills, • High Sense of accuracy, • Knowledge of inventory control, • Assertive; being able to meet high volume demand, • Able to collaborate with all parties necessary to achieve goals, • Knowledge of handheld RF equipment a plus, • Adherence to all OTT Safety, Quality, ISO, and HR policies and standards On Time Trucking, Inc. will consider qualified applicants with a criminal history pursuant to the New York Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if On Time Trucking, Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting

Job DescriptionDescription: The CDL Class A Driver role performs dedicated pick-up and delivery in the local area for assigned routes. This position requires a Class A license, 3 years minimum experience operating a tractor/trailer, clean DMV/Clearinghouse (no major at-fault accidents or speeding in commercial vehicles) and current medical card, city driving experience in all weather conditions and should know the New Jersey area well. Material handling is required. This is a fast-paced, dedicated on-time delivery environment - a sense of urgency and commitment to customer service is a must. Requirements: Responsibilities and Duties: • Keep paperwork and cargo supply organized to facilitate a smooth workflow., • Responsible for occasional route coverage to absence of other drivers., • Load, secure, inspect and fuel before and as necessary during your shift., • Immediately report any problems during route to immediate supervisor., • Assist in helping other drivers during load outs to maintain a safe work environment., • Keep assigned Truck and work area at Terminal organized and clean for safety and efficiency., • Tarp, Strap and Chain (when required) all loads to Federal Cargo Requirements., • Sense of urgency and commitment to customer service., • Ensures that safety requirements are followed by drivers at all times., • Advanced knowledge of DOT rules and regulations, • Route planning for optimal driver and vehicle utilization., • Maintains clear and accurate records and logs., • High school diploma or equivalent, • Class A CDL with 3-5 years of experience, • Clean Clearinghouse record, • Strong math & writing skills, • Customer and Quality focused, • Intermediate computer skills, • 2-4 years of experience in the transportation field or any other related industry, • LEAN understanding with the ability to fully execute 5s and 7s, • Understanding of logistics, shipping, receiving and transportation, • Excellent time management, • Great communication and soft skills, • High Sense of accuracy, • Knowledge of inventory control, • Assertive; being able to meet high volume demand, • Able to collaborate with all parties necessary to achieve goals, • Knowledge of handheld RF equipment a plus, • Adherence to all OTT Safety, Quality, ISO, and HR policies and standards

Job Description Raycap, Inc. is seeking a highly motivated Quality Inspector. In this role, the Quality Inspector inspects components, sub-assemblies, and finished products received and/or built internally. This position works with Quality Management to implement the proper sampling plans based on component specifications, inspection plans, or customer-supplied requirements and to provide guidance on required quality tools, methods, and data to ensure that the shipped product fulfills all customer specifications and quality requirements. This position monitors and maintains Raycap quality processes to assure continual 100% customer satisfaction. Shift: Monday - Friday (11:00 p.m. - 7:30 a.m.) with overtime as required. Primary Job Responsibilities • Collects quality data as required to derive quality objectives, • Executes and maintains comprehensive quality product inspections, • Serves as a manufacturing focal point for intelligent analysis of quality issues, determining true root causes, and implementation of permanent corrective and preventive actions, • Follows and promotes the use of and implementation of internal quality standards and procedures, • Reviews documentation for compliance with quality standards, • Inspects First Articles, incoming components, raw materials, fabricated parts, and in-process assemblies and subassemblies, products per Inspection Plans and Specification Requirements, • Conducts subassembly tests as required to ensure quality products, • Uses measuring equipment such as calipers and gauges, • Audits and monitors quality requirements in accordance with the company's quality assurance policies and customer specifications, • Documents and reports inspection findings, results, and monitors corrective actions to the inspection findings, • Regular adherence to performance of applicable procedures in the Quality Management Systems (QMS), Environmental Management (EMS), and Occupational Health & Safety standards (OHSAS); ensuring processes remain sustainable, suitable, and effective in relation to the position, • Hands-on quality and manufacturing experience in an ISO certified environment., • Proficient in MS Office, Access, Outlook, and Adobe programs, • Experience with Document Control software, • Familiarity with SAP, ISO-9001, knowledge and application of DFx, FMEA, or similar Quality Systems is a plus Who We Are Raycap, Inc. creates products that protect and support the world’s most valuable assets. We support advanced solutions for telecommunications, renewable energy, transportation, defense, and other applications worldwide. We offer • A competitive benefit package, • Paid Time Off from day one, • 10 annual company-paid holidays, • A Tuition Reimbursement program, • A generous 401(k) employer contribution Raycap is an Equal Opportunity / Affirmative Action Employer. All qualified applicants receive consideration for employment without regard to age, disability, race, color, national origin, sex, marital status, sexual orientation, gender identity, religion, creed, veteran or military status, or other protected status. We participate in E-verify for all employment verifications. Drug-free workplace.

Job Description Job Title: Manufacturing Quality Technician II Job Duration: 6 Months Contract – W2 Job Location:2 Henderson Dr, West Caldwell, NJ 07006 (Onsite) Note: Schedule and Shift: 9-80 A|1st Shift|07:30 AM This position will also support Saddle River NJ and Huntsville AL but will be based out of West Caldwell Description: Mercury Systems is seeking a talented individual to help drive cutting edge technology to mission critical aerospace and defense applications. As a Quality Technician, you will support our team of quality engineers by providing both technical and administrative assistance. You will be responsible for ensuring the accuracy of production records, discrepancy reports, and supplier documentation. Additionally, you will collaborate with operations, quality, purchasing, and stockroom to help achieve team objectives and drive continuous improvement. Job Responsibilities: • Accurately completes AS9102 First Article Inspection Report (FAIR) and other dimensional inspection reports., • Accurately reviews AS9102 First Article Inspection Report (FAIR) and other dimensional inspection reports from suppliers., • Accurately compiles and completes End Item Data Packages (EIDP), • Administrate and maintain calibration system complying to AS9100 and ISO 17025 for equipment., • Updating calibration system cycle inventory across sites., • Serve as the ESD coordinator for the site, • Perform comprehensive ESD program audits per ANSI/ESD S20.20 standards, • Inspect all grounding systems, flooring, and workstations, carts and shelving units, • Verify compliance with Mercury Systems’ internal ESD policies, • Test equipment calibration & certification, • Data Review, Reporting & Corrective Actions, • Navigates internal company software and database systems to gather quality data information., • Administrate and maintain calibration system to current updates., • Create and submit Purchase Requisition (PR) to procurement department for Purchase Order release., • Request quotes from external calibration houses., • Coordinate with operations on site calibration schedule for stationary equipment., • Support QA receiving inspection, in-process inspection and final inspection activities, • Interprets and understand drawings, specifications, customer requirements, • Works effectively with and communicates with various departments including operations, planning, quality, and QC inspection, • KPI/Metrics Review & Reporting, • Maintain and ensure accurate record-keeping of production documentation, • Collect and Index supplier-provided documentation for components and services, • Typically requires a minimum of three (3) years of quality assurance experience, • High School diploma or General Education Degree (GED), • Previous AS9102 First article inspection experience, • Previous AS9100 Quality Management Standard experience., • Previous IPC-A-610 and IPC-J-STD-001 training and/or certification., • Familiar with GD&T terminologies print reading, • Experience with electrical and mechanical inspection tools., • Strong PC skills with Microsoft Office – Excel, Word, Power Point, Minitab, JMP and database systems, • Experience in aerospace and defense industry, • Experience with any of the following business application systems – Oracle, Factory Logics, Power BI, Tableau, Agile, Net-Inspect Thanks and Regards, Jaswanth, Technical Recruiter Phone- (614) 953-0332 | || | Global Workforce Solutions | Certified MBE & EDGE Company | Microsoft Partner Direct Hire | Contingent Staffing | SOW Services | Clinical Staffing| IT Consulting | Payrolling You should be proficient in: • IPC-A-610, • IPC Joint Industry Standard (IPC-J-STD), • AS9100, • AS9102, • High School / GED, • ERP Software (Oracle)

Job Description Job Title: Manufacturing Quality Technician II Job Duration: 6 Months Contract – W2 Job Location:2 Henderson Dr, West Caldwell, NJ 07006 (Onsite) Note: Schedule and Shift: 9-80 A|1st Shift|07:30 AM This position will also support Saddle River NJ and Huntsville AL but will be based out of West Caldwell Description: Mercury Systems is seeking a talented individual to help drive cutting edge technology to mission critical aerospace and defense applications. As a Quality Technician, you will support our team of quality engineers by providing both technical and administrative assistance. You will be responsible for ensuring the accuracy of production records, discrepancy reports, and supplier documentation. Additionally, you will collaborate with operations, quality, purchasing, and stockroom to help achieve team objectives and drive continuous improvement. Job Responsibilities: • Accurately completes AS9102 First Article Inspection Report (FAIR) and other dimensional inspection reports., • Accurately reviews AS9102 First Article Inspection Report (FAIR) and other dimensional inspection reports from suppliers., • Accurately compiles and completes End Item Data Packages (EIDP), • Administrate and maintain calibration system complying to AS9100 and ISO 17025 for equipment., • Updating calibration system cycle inventory across sites., • Serve as the ESD coordinator for the site, • Perform comprehensive ESD program audits per ANSI/ESD S20.20 standards, • Inspect all grounding systems, flooring, and workstations, carts and shelving units, • Verify compliance with Mercury Systems’ internal ESD policies, • Test equipment calibration & certification, • Data Review, Reporting & Corrective Actions, • Navigates internal company software and database systems to gather quality data information., • Administrate and maintain calibration system to current updates., • Create and submit Purchase Requisition (PR) to procurement department for Purchase Order release., • Request quotes from external calibration houses., • Coordinate with operations on site calibration schedule for stationary equipment., • Support QA receiving inspection, in-process inspection and final inspection activities, • Interprets and understand drawings, specifications, customer requirements, • Works effectively with and communicates with various departments including operations, planning, quality, and QC inspection, • KPI/Metrics Review & Reporting, • Maintain and ensure accurate record-keeping of production documentation, • Collect and Index supplier-provided documentation for components and services, • Typically requires a minimum of three (3) years of quality assurance experience, • High School diploma or General Education Degree (GED), • Previous AS9102 First article inspection experience, • Previous AS9100 Quality Management Standard experience., • Previous IPC-A-610 and IPC-J-STD-001 training and/or certification., • Familiar with GD&T terminologies print reading, • Experience with electrical and mechanical inspection tools., • Strong PC skills with Microsoft Office – Excel, Word, Power Point, Minitab, JMP and database systems, • Experience in aerospace and defense industry, • Experience with any of the following business application systems – Oracle, Factory Logics, Power BI, Tableau, Agile, Net-Inspect Thanks and Regards, Jaswanth, Technical Recruiter Phone- (614) 953-0332 | || | Global Workforce Solutions | Certified MBE & EDGE Company | Microsoft Partner Direct Hire | Contingent Staffing | SOW Services | Clinical Staffing| IT Consulting | Payrolling You should be proficient in: • IPC-A-610, • IPC Joint Industry Standard (IPC-J-STD), • AS9100, • AS9102, • High School / GED $25 - $27 / hr

Job Description General Purpose The Incoming Inspector is responsible for the inspection and verification of incoming raw materials, components, and outsourced parts used in HYTORC’s electric and hydraulic tools. This role ensures that all incoming products meet the required specifications, quality standards, and documentation requirements . The Incoming Inspector will work closely with suppliers, purchasing, and quality teams to resolve quality issues and maintain compliance with industry standards. Essential Duties and Responsibilities • Inspect and verify incoming raw materials, machined components, and subassemblies for compliance with engineering drawings, specifications, and quality requirements., • Perform dimensional inspections using precision measurement instruments (calipers, micrometers, height gauges, bore gauges, Comparators, CMM)., • Verify material certifications, supplier documentation, and compliance with required standards., • Record and maintain inspection results, nonconformance reports, and supplier performance data., • Work closely with Quality Control, Purchasing, and Engineering to address discrepancies or nonconforming materials., • Segregate and label nonconforming materials, coordinating with purchasing for supplier returns or corrective actions., • Control of MRB and quality hold areas., • Follow and support ISO 9001:2015 quality management processes., • Ensure inspection tools and gauges are calibrated and in good working condition., • Maintain a clean, organized, and safe work area in accordance with company policies. Supervisory Responsibilities None Education/Experience Required • Minimum 2–4 years of experience in a quality control or inspection role., • Experience in the inspection of mechanical components and assemblies, preferably for industrial tools or related equipment., • High School Diploma or equivalent required., • Technical or trade school training in mechanical inspection, or a related field is preferred., • Ability to read and interpret engineering drawings, blueprints, and GD&T specifications., • Proficient in the use of precision measuring instruments and inspection equipment., • Understanding of material certification requirements and industry quality standards., • Experience with CMM operation and basic programming a plus., • Strong attention to detail and accuracy in record-keeping., • Familiarity with ISO 9001:2015 quality systems preferred. Computer Skills Necessary • Microsoft Office, • Experience with CMM software (e.g., Wenzel, Mitutoyo, Zeiss, or equivalent). Physical Demands/Requirements • Ability to stand for extended periods during inspections., • Ability to lift up to 50lbs. occasionally.

Job DescriptionQuality Control Microbiology Engineer(s) I, II, III Quality Control Microbiology Engineer I The “Quality Control (QC) Microbiology Engineer I” will support two local sites serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of QC Microbiology, responsibilities of the QC Microbiology Engineer I will include but are not limited to: Microbiological Testing: • Growth Promotion, • Microbial Identification, • Sterility Testing, • Gram Stain, • EndotoxinEquipment Monitoring:, • Ensure equipment is in proper working conditions, • Ensure all equipment is properly maintained/calibrated, • Shipping of test samples and equipment to contract laboratories for testing, • Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).REQUIREMENTS, • Associates degree in a science or relevant field required, • Training in GxP/ GDP, Safety, • Minimum 0-2 years of experience or equivalent experience., • Microbiology testing or within the biopharmaceutical industry experience preferred., • Proficient with computer software; Microsoft Office, • Strong written and oral communication skills, • 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 responsibilities, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels, • Must be able to work during the weekend, holidays and as required by the company, • Duties, responsibilities, and activities may change at any time with or without notice.QC Microbiology Engineer II The Quality Control Microbiology Engineer II will support two local sites serving as a support role to clinical and commercial production. The QC Microbiology Engineer II will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the QC Microbiology Engineer II will include but are not limited to: Microbiological Testing:, • Growth Promotion, • Microbial Identification, • Sterility Testing, • Gram Stain, • EndotoxinEquipment Monitoring:, • Ensure equipment is in proper working conditions, • Ensure all equipment is properly maintained/calibrated, • Shipping of test samples and equipment to contract laboratories for testing, • Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Writing/conducting investigations pertaining to microbiological testing, • Develop and train QC Microbiology Engineer I personnel on relevant business processesREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 2-4 years of experience with microbiological testing or within the biopharmaceutical industry., • Training in GxP/GDP, Safety, • Proficient with computer software such as; Microsoft Office, • MODA/LIMS, • Familiarity with ISO and EU standards, • Strong written and oral communication skills, • Technical writing skills, • Technical training ability, • 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 responsibilities, • Supervisory Responsibility, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels., • 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., • 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 company, • Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator., • Duties, responsibilities, and activities may change at any time with or without notice.QC Microbiology Engineer III The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the QC Microbiology Engineer III will include but are not limited to:, • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experience, • 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 responsibilities, • Supervisory Responsibility; Direct reports, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels., • 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 company

Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust 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 responsibilitiesSupervisory Responsibility; Direct reportsWhile 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.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.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 company.Working EnvironmentWhile 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.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.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 work during the weekend, holidays and as required by the companyMust 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.

Role Overview Mercor is seeking experienced insurance underwriting professionals to collaborate with a technology-driven risk analytics partner. Freelancers will support the development and evaluation of automated insurance workflows, contributing expert insight to improve AI systems handling underwriting, risk assessment, and rating logic. This opportunity is ideal for professionals with property and casualty underwriting experience looking to apply their knowledge in a forward-looking, project-based environment. Key Responsibilities - Evaluate application data, loss history, and third-party reports (e.g., CLUE, MVR, LexisNexis) to determine underwriting acceptability. - Calculate insurance premiums using ISO manuals, class codes, and company-specific rating algorithms. - Analyze historical claims to assess loss trends and calculate loss ratios against industry benchmarks. - Draft policy terms and compile coverage documents including endorsements and declarations. - Review referred cases and provide documented decisions with clear rationale and risk treatment recommendations. Ideal Qualifications - 5+ years in commercial or personal lines underwriting, preferably with experience using platforms like Guidewire or Duck Creek. - Familiarity with ISO classification codes, rating manuals, and policy forms. - Strong attention to detail and ability to assess risk across various data inputs. - Proven track record of working with multi-line policies (property, auto, general liability). - Experience reviewing and interpreting third-party reports (CLUE, MVR, LexisNexis, etc.). More About the Opportunity - Remote and asynchronous — control your own work schedule - Expected commitment: min 30 hours/week - Project duration: ~6 weeks Compensation & Contract Terms - $50-80/hour - Independent contractor arrangement - Paid weekly via Stripe Connect Application Process - Submit your resume followed by domain expertise interview and short form About Mercor - Mercor is a talent marketplace that connects top experts with leading AI labs and research organizations. - Our investors include Benchmark, General Catalyst, Adam D’Angelo, Larry Summers, and Jack Dorsey. Thousands of professionals across domains like law, creatives, engineering, and research have joined Mercor to work on frontier projects shaping the next era of AI

Help shape the future of nuclear medicine! SOFIE is seeking a Product Development Specialist to lead the development, implementation, and validation of manufacturing and analytical methods for innovative diagnostic and therapeutic radiopharmaceuticals. In this role, you’ll collaborate closely with leading pharmaceutical partners to bring new products from concept to reality—ensuring every process meets the highest standards of quality and regulatory compliance (21 CFR 211 and 212). If you’re driven by innovation and excited to make a tangible impact in the advancement of healthcare, we want to hear from you. Title | Product Development Specialist Location | Totowa, NJ Department | Radiopharmaceutical Contract Manufacturing (RCM) Reports To | Director, Radiopharmaceutical Contract Manufacturing (RCM) Shifts: 9am-5pm Compensation: $90,000-$100,000 ( based on experience and education) Overview The Product Development Specialist will lead the development, implementation, and validation of manufacturing and analytical methods of new diagnostic and therapeutic radiopharmaceuticals for SOFIE, within the Radiopharmaceutical Contract Manufacturing Division. Working closely with SOFIE’s pharmaceutical partners, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and 212). Essential Duties and Responsibilities  Develop protocols for the production and analysis of clinical-grade radiopharmaceuticals, validate these methodologies against quality requirements, and implement them for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards. o It is expected that the development of these protocols will involve both the application of scientific principles, and rationales, and adherence to regulatory requirements.  Write clear Standard Operating Protocols (SOPs) for these protocols.  Review existing SOPs and suggest logical modifications based on either scientific rationales and/or regulatory requirements.  Provide technical support and/or training for production staff at SOFIE sites, either remotely or on-site.  Write corporate exception reports and other regulatory documents, such as risk assessments, change controls, etc.  Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.  Install, qualify, and maintain laboratory equipment on site.  Validate existing production or analytical methods on existing or new equipment.  Collaborate with other production radiochemists and quality control chemists as required to ensure successful protocol development and radiopharmaceutical production.  Perform release testing, according to SOPs, on other materials (e.g., raw materials for radiopharmaceutical production).  Maintain all qualification and validation requirements for entering ISO classified areas.  Maintain a clean and safe working environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations.  Maintain accurate radiopharmaceutical production records and test/validation results.  Write reports, presentations, and other documentation summarizing experimental/production data.  Coordinate with the Radiopharmaceutical Contract Manufacturing team’s activities to reach defined objectives.  Liaise with our contract partners (e.g., biotech and pharma).  Other duties as assigned. QUALIFICATIONS  A degree in chemistry, engineering or natural sciences preferred but will still entertain applicants with relevant education and work experience. PhD preferred.  3-years’ experience preferred in radiopharmaceutical manufacturing and QC in a GMP or academic environment  Expertise in laboratory procedures and analytical chemistry techniques required (thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.). Experience with the use of automated synthesis modules and maintenance of automated modules required.  Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.  Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification preferred.  Efficient in the use of MS Office Suite required.  Ability to be detail-oriented, accountable, patient, organized, and work in a team environment with minimum supervision required.  Strong technical writing skills required.  Excellent organizational skills required  Ability to work various shifts and weekends required.  Travel: up to 25% domestically.

Compensation $20-$22/hour Overview: The Aseptic Cleaning Technician will perform facility GMP and non-GMP cleaning, maintenance, and organization in support of all activities on site. Cleaning and disinfection of the ISO 7 cleanrooms daily, monthly, and quarterly or as needed. Cleaning and disinfect

Job Description Job Summary: The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes. Key Responsibilities: • Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers., • Prepare detailed audit plans, checklists, and schedules., • Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines., • Review and approve deviations, CAPAs, and change controls., • Document audit observations and issue formal audit reports., • Track and verify implementation of corrective and preventive actions (CAPAs)., • Provide guidance on compliance requirements and audit readiness., • Support regulatory inspections and customer audits., • Identify systemic issues and recommend process improvements., • Stay updated on evolving regulatory requirements and industry best practices. Qualifications: • Bachelors degree in Life Sciences, Pharmacy, or related field., • 3-5 years in Radio Pharmaceuticals, with at least 2 years in auditing., • Strong knowledge of RPT cGMP, GDP, and global regulatory requirements., • Excellent attention to detail and analytical skills., • Strong communication and report-writing abilities., • Ability to travel (up to 10%) for audits. Preferred Certifications: • ASQ Certified Quality Auditor (CQA), • ISO 9001 Lead Auditor, • GCP/GMP auditing certifications

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

Job Description We are an established precision engineering and manufacturing firm located in Northern New Jersey. We specialize in the fabrication of high-tolerance, critical components for the medical device, aerospace, and specialized industrial sectors. Operating within an ISO-compliant framework, we leverage advanced CNC technology and a commitment to lean manufacturing to serve a global client base. We are currently seeking a General Manager of Manufacturing to lead our production facility, oversee a technical workforce, and manage our end-to-end supply chain. The Role The General Manager will have full operational oversight of our New Jersey facility. This is a high-impact leadership role requiring a blend of technical machining knowledge and sophisticated business management. You will be responsible for ensuring production efficiency, maintaining rigorous quality standards, and optimizing the logistical flow from raw material procurement to final fulfillment. Key Responsibilities: • Facility & Production Management: Direct all shop floor activities, ensuring that production schedules align with customer demand and high-tolerance specifications., • Strategic Supply Chain Oversight: Manage ERP-driven inventory systems, raw material sourcing, and vendor relationships to ensure a seamless production pipeline., • Quality & Compliance: Maintain and enforce ISO-standard quality control protocols to ensure zero-defect delivery of precision components., • Team Leadership: Supervise a technical production team and administrative staff, emphasizing a culture of accountability, precision, and safety., • Operational Optimization: Identify and implement process improvements (Lean/Six Sigma) to maximize CNC throughput and minimize operational waste., • Forecasting & Reporting: Work closely with executive leadership on sales forecasting, inventory modeling, and facility scaling. Qualifications: • Experience: 7+ years of leadership experience in a regulated manufacturing or high-precision machining environment., • Technical Knowledge: Deep familiarity with CNC manufacturing workflows, metallurgy, and integrated ERP/MRP systems., • Regulatory Savvy: Experience working within ISO 9001 or ISO 13485 environments is highly preferred., • Local Residency: Must be located within a commutable distance of Bergen County, NJ., • Mindset: A systems-oriented leader who is equally comfortable in a high-level strategy meeting or conducting a quality check on the shop floor.Company DescriptionPlease note: This is a confidential search. To ensure a seamless leadership transition and protect our ongoing strategic projects, the company name will be disclosed to qualified candidates following an initial screening call. Candidates should be prepared to execute a standard Non-Disclosure Agreement (NDA).Please note: This is a confidential search. To ensure a seamless leadership transition and protect our ongoing strategic projects, the company name will be disclosed to qualified candidates following an initial screening call. Candidates should be prepared to execute a standard Non-Disclosure Agreement (NDA).

Job DescriptionBenefits: • 401(k), • Health insurance Position Summary: A well-established precision manufacturer in the aerospace and defense sector is seeking a Director of Quality to lead its quality management systems across casting, machining, and assembly operations. This leadership role is critical to ensuring compliance with industry regulations, driving continuous improvement, and maintaining the highest standards of quality in production. Key Responsibilities: • Develop, implement, and maintain a robust Quality Management System (QMS) aligned with AS9100, ISO 9001, and Nadcap standards., • Lead internal and external audits, customer quality interactions, and regulatory compliance initiatives., • Oversee dimensional and metallurgical inspection processes, including CMM, GD&T, and non-destructive testing., • Drive root cause analysis and implement corrective and preventive actions (RCCM, 8D, CAPA)., • Manage all First Article Inspection (FAI) and PPAP/APQP activities, including documentation under AS9012 and AS13002., • Collaborate with cross-functional teams (engineering, operations, supply chain) to improve process capability and product quality., • Analyze quality KPIs and initiate continuous improvement programs to reduce scrap, rework, and customer complaints., • Mentor and develop a high-performing team of quality engineers, inspectors, and technicians., • Role is on-site and not eligible for remote work.Qualifications:, • Bachelors degree in Engineering or a related technical field required; advanced degree a plus., • Minimum of 10 years of progressive quality leadership experience in aerospace, defense, or high-precision manufacturing., • Extensive knowledge of quality standards and regulatory frameworks: AS9100, ISO 9001, Nadcap, ITAR., • Experience managing audits and customer approvals (e.g., Boeing, Lockheed, Raytheon, Honeywell)., • Strong background in metrology, GD&T, and non-destructive testing., • Familiar with lean manufacturing, Six Sigma methodologies, and ERP systems.

Job DescriptionOur client is expanding their operations in Passaic County and seeking an experienced Printing Press Supervisor to lead the 2nd shift team. If you have hands-on offset lithography expertise and strong leadership skills, this could be your next opportunity. Responsibilities: • Lead and manage pressroom operations, personnel, and equipment for second shift, • Drive efficiency by reducing setup times, controlling costs, and minimizing downtime, • Maintain pressroom quality standards and monitor workflow, • Oversee production targets, waste-control goals, and inventory for supplies, • Collaborate with customers on press approvals and assist crews with technical challenges, • Ensure compliance with FSSC 22000 certification requirements and promote safety, • Support scheduling, coverage, hiring, and training for team members, • Align print specifications with Graphics Department to maintain G7 standards, • Oversee Sheeting Department operations to meet production goalsQualifications:, • 5+ years operating KBA (Koenig-Bauer), Heidelberg, or Manroland presses (preferably Large Format 7-Color), • 3+ years in a supervisory role with strong leadership and communication skills, • Experience with spectrophotometry, lab color measurement, and FSSC 22000 / ISO 9001 standards, • Bilingual (English/Spanish) preferredBenefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria. If you're ready to lead a dynamic team and deliver top-quality production, we'd love to connect. Apply today and join a company committed to excellence in packaging solutions. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: • The California Fair Chance Act, • Los Angeles City Fair Chance Ordinance, • Los Angeles County Fair Chance Ordinance for Employers, • San Francisco Fair Chance Ordinance Pay Details: $95,000.00 to $120,000.00 per year Search managed by: Mary Hutchins Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: • The California Fair Chance Act, • Los Angeles City Fair Chance Ordinance, • Los Angeles County Fair Chance Ordinance for Employers, • San Francisco Fair Chance OrdinanceMassachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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

Job DescriptionQuality Control Microbiology Analyst II, III QC Microbiology Analyst II The Quality Control Microbiology Analyst II serves as a support role to clinical and commercial production. Microbiology Analyst II will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. This position will report into the Manager of QC Microbiology. • Environmental monitoring in controlled environments; Non-viable particulate monitoring, Active viable air monitoring Personnel monitoring, Surface sampling, Passive air monitoring, • Equipment monitoring; Ensure equipment is in proper working conditions, Ensure all equipment is properly maintained/calibrated, Program equipment with proper workflows, Assist with routine laboratory testing, Plate reads and incubations, • Shipping of test samples and equipment to contract laboratories for testing, • Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Writing/conducting investigations pertaining to environmental monitoring and testing, • Develop and train QC Microbiology Analyst I personnel on relevant business processes.REQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry., • GxP/GDP, Safety Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, • Familiarity with ISO and EU standards, • Strong written and oral communication skills, • Technical training ability, • 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 company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • 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. QC Microbiology Analyst III The Quality Control Microbiology Analyst III serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst III will coordinate data for batch release, participate in project/client meetings, and author/revise environmental monitoring procedures. Additionally, the QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring., • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Analyst II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work ordersREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • GxP/GDP Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experience, • 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 responsibilities, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityWorking Environment, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • 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 clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityPhysical Requirements, • The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • Must be physically capable to stand; walk; site; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear., • Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator.Please note these job descriptions are not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionCompany: Probo Medical Job Title: Mechanical Installation Service Technician Location: Newark, NJ + travel Probo Medical is a diagnostic imaging sales and service provider that delivers high-quality, affordable healthcare products and services to medical practices around the world. With locations that span across the US, Canada, the UK, and parts of Europe, we’ve made it our mission to increase access to life-saving healthcare services for patients worldwide. We empower our teams to solve problems together and build long-lasting relationships with our customers. Establish your purpose-driven career as a Mechanical Installation Service Technician with Probo Medical. You won’t find a more dedicated team of industry professionals to work and grow with. What You’ll Be Doing Mechanical Installation Service Technician work activities may include the coordination and installation, de-installation, relocation, and/or service upgrades of high-value complex equipment in hospitals, universities, and Federal Buildings. Various equipment from each modality may include, but is not limited to, X-ray, CT, MRI, Cardiovascular, and NucMed, and other related technical systems associated with these modalities. Travel Requirements Up to 100% travel throughout the U.S. Frequent travel by car to project sites within 1-2 hours’ driving distance from a project site is required. Overnight travel and air travel to project sites within the assigned territory may be scheduled as business needs require. Pay Range: Typical starting pay is $22-$24 per hour. This range may vary and is based on several factors, including but not limited to geographic location, work experience, education, certifications, etc. Overtime is available. Essential Duties and Responsibilities: • Represent Probo Medical and the customer professionally and courteously while building and maintaining customer relationships., • Become knowledgeable in high-value, complex biomedical equipment., • Follow all Standard Operating Procedures and policies, customer requirements, and statutory and regulatory guidelines., • Assist the Team Leader with coordinating suppliers and help direct on-site deliveries of equipment., • Perform and deliver a safe and timely installation to the customer., • Assist the Team Leader with quality and compliance, customer requirements, and ISO 9001. Ensure each process is followed by each team member., • Maintain the integrity of confidential information. We welcome candidates with electro-mechanical knowledge, mechanical troubleshooting skills, and power tool experience, and those with 1-2 years of related education and experience who are seeking to grow their skills. New graduates are welcome to apply. We train those who are eager to learn! Additionally, we seek: • An associate's degree (A. A.) or equivalent from a two-year university or technical school is preferred., • A high level of patience, attention to detail, and adaptability., • Self-starter able to work as a team and independently without much oversight., • Ability to prioritize assignments and effectively communicate timelines and workload., • Solid communication and interpersonal skills. Must be able to read, write, and speak English fluently., • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals., • Knowledge of how to compute rate, ratio, and percentage, and draw and interpret bar graphs., • Ability to add, subtract, multiply, and divide in all Metric and Standard units of measure and use leveling methods to complete related work activities., • MS Office proficiency (Word, Excel, Outlook)., • The use of both hands and fingers with dexterity., • Great hand/eye coordination and ability to work on a ladder., • Must be able to lift up to 75 lbs. of cables or equipment. Our Total Rewards Offering Probo Medical offers a competitive compensation and benefits package, coupled with excellent career development opportunities and a challenging and team-oriented work environment to help you succeed in your career. Visit us at probomedical.com to learn more. If you have a passion for hands-on work, solid mechanical problem-solving and troubleshooting skills, and enjoy being part of a high-growth company that strives for excellence and making a difference in people’s lives, we would like to meet you! Apply Today! We Make it Easy Founded in 1901, MRA is a nonprofit employer association that serves more than 4,000 employers, covering more than one million employees. As one of the largest employer associations in the nation, MRA helps its member organizations thrive by offering the most comprehensive assortment of HR services, information, education, and resources to help build successful workplaces and a powerful workforce. We partner with these companies working directly with their HR department and leadership to hire their talent. We are a direct line to the company, not an agency recruiter. Powered by JazzHR FJYrDYgKXn

Job Description Summary: The Enterprise Technology Risk Analyst identifies, assesses, and monitors technology risks across the organization. The role provides second-line oversight and independent challenge, helps maintain compliance with regulatory and industry standards, and strengthens the company’s overall security posture. You will work cross-functionally to execute risk assessments, maintain continuous monitoring, track issues and exceptions, and prepare clear reporting for management and committees. Job Responsibilities: Risk Assessment and Control Assurance • Perform technology risk assessments to identify vulnerabilities and threats., • Maintain and improve technology risk indicators and control monitoring routines., • Monitor and report on technology risk metrics and performance indicators., • Maintain the process, risk, and control library., • Update policies, standards, and procedures aligned to ISO 27001., • Provide second-line challenge on projects, changes, and new technologies., • Log and track risk exceptions and issues, including documentation of mitigation plans., • Monitor status, escalate delays, and verify remediation effectiveness., • Bachelor’s degree (or Associate’s with equivalent experience) in Information Technology, Cybersecurity, Risk Management, or related field., • 2+ years of experience in IT risk management, internal/external audit, ITGC testing, or control assurance., • Working knowledge of regulatory and industry frameworks (e.g., ISO 27001 & 27002, NIST CSF, Cyber Risk Institute Profile)., • Strong analytical, writing, and problem-solving skills., • Medical, Dental, Vision and Rx which are contributory., • Bonus programs., • Employee Stock Option Program (ESOP)., • Life Insurance, Long Term Disability and Accidental Death and Dismemberment (LTD&AD&D)., • Paid Time Off (PTO) which includes Personal and Vacation Time., • Paid Sick Time., • Bank Holidays. This role is eligible for a hybrid schedule; 3 days in the office and 2 days work from home based on business need. Columbia Bank and its affiliates is an Equal Opportunity Employer, including individuals with disabilities and veterans.

Job DescriptionSalary: $75k - $90k MAC Products, one of the premier mass transit and utilities manufacturers in the North Jersey area, is looking for a proactive Quality Engineer to join our team. You will be a key player in maintaining and improving the high standards of our manufacturing processes. We need a self-motivated, hands-on professional unafraid to tackle problems and solve challenges. Responsibilities Lead root cause analysis and implement practical corrective and preventive actions. Monitor and improve critical manufacturing processes, including brazing and welding. Conduct internal audits and lead process improvement projects. Provide technical support & training to QC inspectors and collaborate with engineering and manufacturing teams. Collect and analyze quality data to drive proactive improvements. Some travel to customer or supplier sites may be required. Qualifications & Skills Required: Bachelor's or Master's degree in a technical discipline. 3-5 years of experience as a Quality Engineer in a manufacturing environment. Strong working knowledge of ISO 9001:2015. Proven ability to perform dimensional inspections and mechanical testing of parts. Proficiency with Microsoft Office Suite. Preferred: Ability to interpret electrical wiring diagrams or schematics. Familiarity with welding, brazing, or automation in manufacturing. Knowledge of statistical principles and statistical process control (SPC). This is a fast-paced and collaborative culture, so we are looking for candidates who have a background multi-tasking in a team-oriented environment. There is a ton of room for growth as the company looks to expand in the next several years. MAC Products has been in business for almost 60 years and the average employee tenure is well over 10 years, so we are looking for an individual who wants to be here long-term and grow with the company. The role is onsite Monday - Friday at our facility in Kearny, NJ, so candidates must be local / commutable.

Job Description Job Title: Manufacturing Operations Manager Job Description We are seeking a dedicated and skilled Manufacturing Operations Manager to oversee all aspects of our manufacturing operations, ensuring efficiency, quality, and compliance. The ideal candidate will lead a team to optimize processes and support internal departments, fostering a collaborative and innovative work environment. Responsibilities • Oversee all manufacturing operations, including machining, painting, quality control, customer service, and assembly., • Implement production planning, scheduling, and budget planning processes, including cost and capital expenditures, and analyze costs and variances., • Review and optimize current manufacturing processes with a focus on safety, quality, and efficiency., • Coordinate with business units to establish centers of excellence and achieve revenue targets., • Collaborate with Finance, Sales, and Supply Chain departments within a matrix structure., • Ensure compliance with export control, ITAR, EAR standards, and EHS/OSHA regulations., • Lead product realization for prototyping and small serial production., • Develop and execute annual plans with senior management for program expansion and future business needs., • Facilitate technology transfer between European and U.S. production sites., • Build and maintain a well-run organization, promoting a friendly and fast-paced environment., • Promote teamwork and success through continuing education and the implementation of new technology., • Bachelor’s Degree (or higher) in Engineering or related field., • Minimum 5 years of management experience in a customized engineering and manufacturing environment., • Experience in manufacturing electro-mechanical components., • Excellent communication, public presentation, and meeting management skills., • Practical experience with quality management systems and ISO 9001., • Knowledge of cost management/control, planning, and budgeting., • Strong understanding of quality improvement processes and auditing of manufacturing processes., • Skilled in quality assurance tools with practical experience in FMEA and Failure Analysis Methods., • Experience in electrical engineering and customer-oriented design for low-volume/high mix production., • Preferred 3+ years of SAP experience; a plus for SAP implementation experience., • Reliable and strategically minded., • Highly motivated personality; team leader, coach, and integrator., • Success-oriented, entrepreneurial, and straightforward mentality with consensus-building ability., • Strong verbal and written communication skills; excellent interpersonal skills., • Quality-conscious, well-organized, and detail-oriented with a hands-on approach., • Independent and self-motivated, with the right amount of drive. The New Jersey facility is a state-of-the-art aerospace and defense site, home to 70 employees with approximately 50 in operations and the remainder in support roles such as engineering, HR, and finance. The environment is family-oriented, promoting teamwork and integrity, where employees contribute to high-quality, American-made aerospace and defense products. Dress code is professional and safety-compliant. Job Type & Location This is a Permanent position based out of Moonachie, NJ. Pay and Benefits The pay range for this position is $110000.00 - $130000.00/yr. TBD - getting information from client Workplace Type This is a fully onsite position in Moonachie,NJ. Application Deadline This position is anticipated to close on Dec 23, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job DescriptionCompany Description ABOUT LGC STANDARDS: LGC Standards is a division of LGC Group, the UK’s designated National Measurement Institute for chemical and bioanalytical measurements. We are a leading global manufacturer and service provider of quality assurance and research tools, supporting analytical needs in more than 120 countries worldwide. We use our expertise to produce to the highest standards, including ranges produced under ISO/IEC 17025 and accredited to ISO 17034. Our wide range of reference materials and proficiency testing schemes is complemented by our experience in outsourcing and customs, enabling us to adapt quickly to provide tailored solutions that meet our customers’ analytical needs. We innovate and apply science in order to ensure the safety and integrity of products and services, in line with our vision of science for a safer world. Job Description The Account Manager will build strong relationships with key internal and external stakeholders and grow the Mid-Atlantic territory revenue of the Standards business with a primary focus in the Reference Materials and Analytical Standards product lines. What you’ll do • Own all assigned Commercial accounts and Strategic site-level locations (e.g., regional labs for multinationals), representing the entire LGC Standards portfolio across all end-markets (Pharma, Biotech, Environmental, etc.) to build new and maintain existing account relationships, • Identify and close new opportunities attained from either prospecting as self-generated leads or from marketing as marketing-qualified leads, • Involve additional LGC Standard’s team members and resources (e.g., end market sales managers, quoting specialists, etc.) on an as-needed basis to best service customer needs and to achieve the highest level of customer experience, • For relevant sites at specific strategic accounts, collaborate with the Sr. Director, Strategic & Commercial Accounts, to conduct planning and customer reviews, • Use LGC’s sales tools to manage prospects, existing accounts, new opportunities, the active pipeline and relevant sales forecasts in an accurate and timely manner, • Develop an in-depth understanding of key LGC products and their applications, • Meet and exceed assigned sales targets for LGC Standards., • Actively engage with customers (e.g., email, phone calls, in-person visits, etc.) to qualify leads, convert prospects, follow-up on quotations and drive new sales and accordingly maintain CRMs with up-to-date customer information, • B.S. in chemistry, physics, biochemistry, biology, or equivalent, • 5+ years’ experience in selling technical products used in research laboratories: Prior successful key account management experience dealing with central procurement is preferred, • Able to read and interpret documents such as RFQs, contracts, operating and maintenance instructions and procedure manuals, • Experience with customer relationship management platforms such as Sales Force and Desk. Expertise in Microsoft Office products is a plus, • Outstanding commercial awareness and planning abilities, • Proven track record of meeting and exceeding sales targets, • Fluency in English essential with additional languages an advantage, • Willing to travel up to 40% within the designated territory as required Additional Information What We Can Offer You: LGC recognizes benefits are key resources as you navigate your well-being journey. We’re pleased to offer comprehensive programs that are focused on supporting our employees and families’ well-being. Many of our benefit programs are effective the 1st of the month following hire date. • 401K matching for US Employees., • Paid Holidays, which include floating days and a holiday shutdown in December., • Comprehensive Benefits Package., • Professional development and extended growth opportunities across the CDN, TRC and LGC networks. LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality, and range. OUR VALUES • PASSION, • CURIOSITY, • INTEGRITY, • BRILLIANCE LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership. For more information about LGC, please visit our website #scienceforasaferworld

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

Job Description GMP Sr. Auditor Paramus, NJ Experience level: Mid-senior Experience required: 5 Years Education level: Bachelors degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No Job Summary: The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes. Key Responsibilities: Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers. Prepare detailed audit plans, checklists, and schedules. Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines. Review and approve deviations, CAPAs, and change controls. Document audit observations and issue formal audit reports. Track and verify implementation of corrective and preventive actions (CAPAs). Provide guidance on compliance requirements and audit readiness. Support regulatory inspections and customer audits. Identify systemic issues and recommend process improvements. Stay updated on evolving regulatory requirements and industry best practices. Qualifications: Bachelors degree in Life Sciences, Pharmacy, or related field. 35 years in Radio Pharmaceuticals, with at least 2 years in auditing. Strong knowledge of RPT cGMP, GDP, and global regulatory requirements. Excellent attention to detail and analytical skills. Strong communication and report-writing abilities. Ability to travel (up to 10%) for audits. Preferred Certifications: ASQ Certified Quality Auditor (CQA) ISO 9001 Lead Auditor GCP/GMP auditing certifications

Job DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional weekends, nights, and/or holidays as required/necessary.May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.Must be able to handle the standard moderate noise of the manufacturing facility.Must be able to work in open floor plan environment and may work in close proximity to others.Wheel-o-Vator available for use.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionPay Range: 60k to 70k with Quarterly Bonus THE COMPANY In business since 1969, Interport modifies and sells new and used shipping containers, serving customers throughout the Northeastern U.S. Established in 2004, Interport Secure Parking operates 24/7/365 secure facilities in Newark, NJ and Savannah, GA where local and regional intermodal drayage truckers park and store loaded and empty import and export containers being transported for global cargo owners, ocean carriers, and third-party logistics providers. Interport proudly employs and empowers a diverse team of exceptional individuals committed to providing our customers superior products, services, and solutions. THE POSITION The Operations Supervisor for Container Sales & Modifications is responsible for overseeing the daily operations of the Modification Shop, supervising staff, and ensuring quality control in all modification projects. This role involves coordinating production schedules, maintaining a safe and efficient work environment, and supporting various operational needs as directed by the Senior Director of Production. MAJOR DUTIES AND RESPONSIBILITIES • Supervise and manage shop & yard personnel, include welders, framers, painters, shop assistants, and machine operators, ensuring efficient scheduling and timekeeping., • Oversee and participate in modification work, including spray paint booth operations and facility maintenance., • Ensure quality control for all modification projects, maintaining compliance with safety and operational standards., • Operate and oversee the safe use of lift equipment in the shop and spray paint booth., • Procure, track, and manage tools, materials, and supplies required for modification work., • Liaise with Operations staff responsible for equipment control and customer service, • Assist in identifying labor, material, and time requirements by studying proposals, blueprints, specifications, and related documents, • Address and resolve discrepancies by collecting and analyzing information, • Collaborate internally on Modification Shop-related matters; and coordinate with Sales Yard staff responsible for equipment control and customer service., • Investigate and resolve customer complaints in coordination with the Senior Director of Production, • Participate in Interport safety programs and ensure adherence to workplace policies and procedures, • Assist with special projects and take on additional responsibilities as needed. MINIMUM REQUIREMENTS, • High school diploma or general education degree (GED), • Minimum five (5) years of experience in container modification, metalworking, or related field, • Minimum of two (2) years of supervisory experience in production or manufacturing environment, • Hands-on experience with steel fabrication, including cutting, welding, burning, and plasma cutting, • Construction skills including carpentry and basic wiring, • Ability to read and interpret technical drawings, • Ability to lift up to 50 pounds and sit, stand, or walk for extended periods at a time, • Ability to work in Interport’s Spray Paint Booth, including wearing and working with a respirator, • Willingness to work both indoors and outdoors in different weather conditions, • Proficiency in English, with strong verbal and written communication skills, • Ability to commute to Newark, NJ, with a valid driver's license in good standing, • Strong analytical skills and attention to detail, with proficiency in Microsoft Office, an ability to use ERP system (NetSuite), a good understanding of data analysis methods, and attention to detailPREFERRED/PLUS, • Experience with Microsoft Office applications, • Familiarity with ISO container maintenance and repair standards, • Bilingual in English/Spanish is a plus, • Lean Six Sigma certification or experience PERSONAL ATTRIBUTES THAT HELP MAKE AN INDIVIDUAL SUCCESSFUL IN THIS ROLE, • Lead by example, • Strong work ethic, • Positive and team-oriented attitude, • Commitment to quality and safety, • Effective time management and flexibility, • Manufacturing environment, • Variable weather conditions, • Noise, • Working at heights, • Dust and dirtPHYSICAL DEMANDS, • Standing, sitting or walking for long periods, • Climbing ladders, • Carrying heavy materials and making repetitive motions while painting. OTHER DUTIES Please note that this job description is not designed to cover or contain a comprehensive list 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. WE OFFER • A base hourly wage commensurate with your qualifications, paid weekly, • Participation in our 401(k) retirement savings plan, • Performance-based variable compensation and a discretionary bonus program, • Comprehensive health benefits, • Paid Time Off (vacation/sick time) and holiday pay, • Participation in the company CDL training program Powered by JazzHR rV8Lu4yCXu

Job Description Will not relocate. US citizens need only to apply. Eastern Industrial Automation, Inc. (EIA) is seeking an experienced Vibration Technician for its growing customer base throughout the NJ, NY, PA, MD marketplace. We have an existing team of well-trained Field Analysts and Technicians to support this newly created position. EIA is a well-established Industrial Distributor, Manufacturer and Field Service Company to tens of thousands of customers throughout the East Coast. Due to our much decentralized, self-starting, professional family culture, we are growing at an aggressive pace! We are seeking a new team member to perform data collection and field service, in support of our local sales staff and existing customer base. Responsibilities: • Perform vibration data collection, vibration data analysis, and timely reporting of machine condition findings., • Perform routine and emergent data collection needs, to a diverse customer base., • Evaluate machinery health, and condition of all types of rotating equipment, through detailed analysis of vibration data., • Conduct failure analysis of rotating equipment to determine root causes of failure and help determine solutions to prevent reoccurrences., • Perform supportive services such as laser alignment, dynamic balancing and oil analysis, • Perform troubleshooting of equipment and instrumentation related to data collection systems., • Perform select field services such as changing sheaves and belts., • Proven experience including certification of ISO category one or equivalent preferred with machinery vibration analysis, • Minimum of two years’ experience in vibration data analysis., • Knowledge of vibration data and analysis techniques., • Experience interfacing with internal teams and external suppliers., • Strong mechanical aptitude and experience working around rotating equipment., • Experience with machine learning and innovation in machinery health assessments is preferred., • Must be willing to travel throughout the local designated market areas. Eastern Industrial Automation provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. The position is 40 hours a week; Monday through Friday, 8AM – 5PM and will report directly to the Engineering Service Manager. An automobile will be provided, gas card, laptop, and Emerson CSI vibration software monitoring equipment. Expected travel throughout the select area is 50-60% with occasional overnight stays. With our diversified product offering and customer base we offer a very stable and growing opportunity for the ideal candidate. Are you ready for a rewarding and challenging career in the distribution/manufacturing industry? We are looking for the best of those who are not afraid to roll up their sleeves to grow with our organization personally and professionally? Powered by JazzHR jIKtwG9aQe

Job Description Founded in 1968, HYTORC is the worldwide leader in industrial bolting solutions. Our mission is to optimize safety, quality and schedule, in industrial bolting through innovative solutions and an unyielding commitment to world class customer service. With over 55 years of experience focused entirely on developing new technologies for hydraulic, electric and pneumatic torque wrenches, while creating a worldwide 24/7 service network, HYTORC has become the most trusted name in the industry. Today HYTORC boasts a series of smart bolting systems that communicate with in-house developed apps for system control, data exchange, and software updates. We are proud to be recognized as the innovation leader in our industry, providing award winning solutions to leading businesses globally. Our customers are in various industries, not limited to Oil & Gas, Wind Power, Nuclear, Aerospace, Transportation including SpaceX, GE, NFL Stadiums, Boeing, Tesla and many more. General Purpose: The Compliance Manager is responsible for implementing and maintaining HYTORC’s Quality Management Systems, handling the day-to-day quality activities in our South Hackensack location, coordinating calibration activities globally and driving continuous improvement. Essential Duties and Responsibilities • Implementing, maintaining and driving continuous improvement of HYTORCS QMSs and accreditation’s, including ISO/IEC 17025, ISO 9001:2015, TUV, KHNP, AD2000, and ISO 80034 Ex Products System, for domestic and international locations., • Managing quality issues and customer complaints., • Facilitating root cause analysis, implementing problem appropriate corrective and preventive actions., • Conducting internal and supplier audits against appropriate standards and guidelines., • Hosting UL/ETL routine inspections and handling issues that arise., • Coordinating with Calibration Lab Managers on quality and equipment needs and issues., • Routinely auditing calibration activities for potential process deviations., • Developing and maintaining uncertainty budgets for the calibration laboratories., • Developing, monitoring, and maintaining repeatability and proficiency tests used for trend analysis., • Designing and evaluating standard operating procedures for calibration asset management software and uncertainty software for laboratory calibration standards and customer calibration events., • Assisting Engineering with the evaluation of new calibration methods and procedures., • Using statistical techniques to analyze and validate measurement standards and processes., • Ensuring that intermediate checks are performed on calibration standards,, • Authorizing short term extension of intervals on HYTORC standards when requested and to meet HYTORC needs based on valid reasons for interval extension or end of period reliability data., • Supervising the laboratory’s inter-laboratory proficiency testing program and ensuring it is maintained., • Providing training on all QMSs, including re-verification of all personnel as necessary to maintain confidence in tests and/or calibrations performed., • Providing leadership and guidance to the Quality and other departments., • Coordinating with HYTORC’s service department to support actions associated with customer feedback., • Compliance Team (2 Associates), • Additional resources may be added over time as we grow, and needs identified Education/Experience Required • Bachelors degree in a technical field or 8 plus yrs of related experience, • ISO/IEC 17025 (minimum of 5 years’ experience). Experience in calibration and metrology for force/torque and pressure., • ISO 9001:2015 (minimum of 5 years’ experience)., • Three years of experience supervising and managing personnel., • Must be able to understand and interpret statistical data and read drawings, • Excellent communication skills to interface with the customer (internal and external) and with all levels within the organization., • Excellent problem-solving skills., • Microsoft Excel, Word and PowerPoint., • SAP and/or other ERP Systems Physical Demands/Requirements • Ability to lift 30 lbs. with assistance., • Ability to travel domestically and internationally up to 40% of the time. Work Environment: Office, Warehouse, and Labs. The actual base salary a successful candidate will be offered will vary based on factors relevant to the position, as well as geography of the selected candidate. The salary range for this role is $110,000 - $125,000. The actual base salary a successful candidate will be offered within this range will vary based on factors relevant to the position.

Job DescriptionDescription: Leading Freight Forwarder / NVOCC/ Customs House Broker/ Tank Container Operator, with locations in 24 countries and over 3000 employees strong, is seeking a highly motivated and organized individual to fill the position of Strategic Account Manager for the Export department in our Jersey City office. This position offers an exceptional opportunity to participate in the continued growth and expansion of a well-respected organization. Responsibilities Include But Are Not Limited To: • Supervises LLP and Export operations., • Trains and advises the members of team in areas of export processes, export regulations, billing systems and accounting procedures., • Trains and advises the members of the team in areas of LLP execution and data management., • Monitors the team’s performance and identifies transactions and tasks that require special handling or expediting., • Works with clients to execute against blueprint and contracted obligations., • Oversees timely billing (invoice release) & accountability for profit on assigned shipments., • Oversees Preparations, maintains and distributes customer reports and other reports as needed by management., • Provides high level of customer service through pro-active communication with clients via email and phone and EDI concerning status of their shipments., • Completes daily reporting of operational/quality requirements., • Manages and establish processes for department quotes., • Ensures timely and accurately closing/billing of all shipments., • Prepares reports required by customers and Leschaco management., • Alerts clients of special areas of concern or potential problems in their process., • Ensures that all shipment deviations are properly recorded in the Leschaco ABS system., • Communicates changes of U.S. and foreign shipping regulations and procedures to clients., • Oversees the customer export freight forwarding and NVOCC orders according to customer order instructions and profile; US Export regulations, FMC regulations, Leschaco Company and ISO procedures., • Observes and documents individual and team performance and gives feedback., • Ensures export compliance is completed timely and accurate., • Minimum 5 years’ experience in a Supervisory role, • Minimum 5 years’ experience with USA Export Regulations, Incoterms, NVOCC concepts, ISO 9001 procedures and CFR49 hazardous materials regulations., • 5 to 7 years industry experience., • Bachelor's degree (B.A.), • Must possess the ability in problem-solving and experience in managing customer complaints, • Must have the ability multi-task and to deal with dynamic problems and variables., • Must be able to prioritize workload, work independently, be a team player and work in a fast paced environment, • Must possess excellent written and verbal communication skills, • Medical, • Dental, • Vision, • Flexible Spending Account (Medical and Dependent Care), • 401(k) with company match, • Company paid Life Insurance, Short-Term Disability and Long-Term Disability, • Paid Holidays plus PTO and Sick Leave, • Voluntary Time Off, • Employee Assistance Program, • Tuition Reimbursement, • Employee Referral Program Background check required. Only those considered for the position will be contacted. Thank you for your interest.

Job Description Summary: The Information Security Officer will play a critical leadership role in our organization, reporting directly to the Senior Vice President (SVP) and Chief Information Security Officer (CISO). This individual will be instrumental in building and managing key security programs, including threat and vulnerability management, cyber incident response, data security, data protection, security engineering, and cyber risk management and governance. As the right hand to the SVP, the Information Security Officer will have a significant impact on our overall security posture and will be a key contributor to our mission of safeguarding our information assets. Job Responsibilities: Leadership and Collaboration • As a trusted advisor and right hand to the SVP and CISO, provide strategic direction and support in information security, offering technical leadership and mentorship to the security team., • Collaborate with IT, DevOps, and application teams to integrate security practices, act as a subject matter expert for threat detection and vulnerability management., • Ensure compliance with relevant legal, regulatory, and industry standards related to information security., • Bachelor’s degree in Computer Science, Cybersecurity, Information Technology, or a related field (or equivalent experience) required., • A Master’s degree or a relevant advanced certifications (e.g., CISSP, CISM, OSCP, CEH, GIAC) are highly desirable., • Minimum of 10 years of experience in information security, with a proven track record of leadership and management in security roles., • Excellent leadership and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and senior executives., • Ability to think strategically and develop long-term plans for the organization's security posture., • Strong verbal and written communication skills, with the ability to present complex security information clearly and concisely., • Proven ability to analyze complex security issues and develop effective solutions., • Ability to adapt to changing security landscapes and emerging threats., • High ethical standards and a commitment to protecting the organization's information assets., • Deep understanding and experience with implementing or maintaining ISO 27001 cyber security framework., • Strong technical knowledge of security technologies, tools, and practices. Experience in threat and vulnerability management, incident response, data security, and security engineering., • Familiarity with frameworks such as MITRE ATT&CK, NIST CSF, ISO27001 CSF, and OWASP., • Knowledge of Cyber security risk assessment frameworks., • Strong analytical, problem-solving, and decision-making skills., • Medical, Dental, Vision and Rx which are contributory., • Bonus programs., • Employee Stock Option Program (ESOP)., • Life Insurance, Long Term Disability and Accidental Death and Dismemberment (LTD&AD&D)., • Paid Time Off (PTO) which includes Personal and Vacation Time., • Paid Sick Time., • Bank Holidays. This role is eligible for a hybrid schedule; 3 days in the office and 2 days work from home based on business need. Columbia Bank and its affiliates is an Equal Opportunity Employer, including individuals with disabilities and veterans.

Job DescriptionCompany Description Veolia in North America is the top-ranked environmental company in the United States for three consecutive years, and the country’s largest private water operator and technology provider as well as hazardous waste and pollution treatment leader. It offers a full spectrum of water, waste, and energy management services, including water and wastewater treatment, commercial and hazardous waste collection and disposal, energy consulting and resource recovery. Veolia helps commercial, industrial, healthcare, higher education and municipality customers throughout North America. Headquartered in Boston, Veolia has more than 10,000 employees working at more than 350 locations across North America. Job Description Position Purpose: Our growing team is looking for strong asset management professionals interested in working on some of the most exciting and challenging water and wastewater programs in the municipal water sector. The Technical Advisor – Asset Management plays a critical role in the Municipal Water Contract Operations (MWCO) Growth organization. Within the Customer Solutions group, the Technical Advisor works closely with business development teams to develop compelling, coherent, and competitive asset management offerings for municipal O&M clients. This position bridges asset management expertise with client engagement to bring best-in-class solutions reflecting Veolia’s Professional Operations standard of excellence. By combining a deep understanding of municipal utility infrastructure, lifecycle planning, reliability, and risk management, with a consultative, client-first mindset, the Technical Advisor will translate client needs into structured asset management solutions that drive lasting value for our partners and sustainable growth for the business. At Veolia, you will be part of a global leader in resource management, committed to building sustainable communities. As a Technical Advisor in our Customer Solutions group, you will sit at the intersection of strategy, technical excellence, and client partnership — shaping how cities manage and sustain critical water and wastewater infrastructure for the future. Primary Duties/Responsibilities: • Participate in business pursuits for water and/or wastewater activities nationally, including client engagement, system assessments and contributions to statements of qualifications, technical approaches, pricing, proposals, and interviews., • Provide subject matter expertise in the business development process related to asset management discipline, best practices, emerging methods, tools, technologies, etc., • Perform system assessments of municipal water and wastewater utilities, evaluating asset management and capital planning activities to surface potential needs, risks and opportunities for partnership, • Lead the development of strategic asset management plans and solutions for prospective customers, • Provide technical inputs to cost structuring and pricing. Prepare and validate maintenance and life-cycle cost assumptions using computerized maintenance management and asset data, • Serve as a subject matter expert in client meetings and proposal settings to help articulate the value story and position Veolia as a partner of choice., • Contribute to the development of innovative offers in asset management, including opportunities to incorporate digital tools, reliability-centered maintenance practices, and predictive analytics into asset management solutions., • Participate in industry conferences, associations and networks, such as the Society for Maintenance and Reliability Professionals, AWWA (American Water Works Association), etc., • Maintain awareness of industry standards (ISO 55000, IAM frameworks, etc.), technologies, and emerging client needs., • Internal Collaboration, • Mentor and support business developers in incorporating solutions into sales engagements., • Hybrid work environment., • Regular travel is to be expected for client engagement and new business.Qualifications Education/Experience/Background: • Bachelor’s and/or advanced degree in Engineering (civil, mechanical, environmental, or process), Asset Management, Facility/Infrastructure Management, or related field required., • Minimum 8–12 years of experience in asset management for municipal utilities, infrastructure services, or engineering consulting., • Hands-on experience with asset inventories, condition assessments, maintenance planning, and capital planning for the water and wastewater utility industry, • Experience with proposal development, pricing input, or cost model support, • Adept in Computerized Maintenance Management Systems or Enterprise Asset Management tools and data., • Comprehensive understanding of industry-accepted asset management tools and techniques, including asset management planning and gap assessments, asset inventory, condition assessments, risk and performance, maintenance optimization, life-cycle cost analysis, and capital investment planning., • Ability to develop business cases, ROI analyses, and KPI frameworks for asset-intensive operations. Ability to support cost structuring and pricing., • Working knowledge of asset data systems (CMMS, EAM, GIS, or analytics platforms)., • Strong business acumen including financial literacy, strategic thinking, and structured problem-solving., • Consultative communication: active listening, problem definition, translating customer needs into winning strategies and solutions., • Collaborative and influential, comfortable working across technical and client-facing teams., • Excellent presentation and storytelling skills to communicate complex concepts simply and persuasively., • Valid Driver’s license and safe driving record., • Active credential or pursuit of an Asset Management Professional credential (or Certified Asset Management Professional) is highly valued, such as Reliability Leader (CRL) Certification, Certified Maintenance & Reliability Professional (CMRP), Professional Engineer License or Asset Management Professional (AMP / CAMP). Additional Information Pay Range: $160000 to $180000 per year. Benefits: Veolia’s comprehensive benefits package includes paid time off policies, as well as health, dental, vision, life insurance, savings accounts, tuition reimbursement, paid volunteering and more. In addition, employees are also entitled to participate in an employer sponsored 401(k) plan, to save for retirement. Pay and benefits for employees represented by a union are outlined in their collective bargaining agreement. Sick leave – 56 hours; Observed Holidays – 11 days; Vacation – Flexible Time Off Eligible for up to 5 - 15% Annual Performance Bonus We are an Equal Opportunity Employer! All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. The Company reserves the right to modify this information at any time, subject to applicable law.

Job Description Founded in 1968, HYTORC is the worldwide leader in industrial bolting solutions. Our mission is to optimize safety, quality and schedule, in industrial bolting through innovative solutions and an unyielding commitment to world class customer service. With over 55 years of experience focused entirely on developing new technologies for hydraulic, electric and pneumatic torque wrenches, while creating a worldwide 24/7 service network, HYTORC has become the most trusted name in the industry. Today HYTORC boasts a series of smart bolting systems that communicate with in-house developed apps for system control, data exchange, and software updates. We are proud to be recognized as the innovation leader in our industry, providing award winning solutions to leading businesses globally. Our customers are in various industries, not limited to Oil & Gas, Wind Power, Nuclear, Aerospace, Transportation including SpaceX, GE, NFL Stadiums, Boeing, Tesla and many more. General Purpose: The Compliance Manager is responsible for implementing and maintaining HYTORC’s Quality Management Systems, handling the day-to-day quality activities in our South Hackensack location, coordinating calibration activities globally and driving continuous improvement. Essential Duties and Responsibilities • Implementing, maintaining and driving continuous improvement of HYTORCS QMSs and accreditation’s, including ISO/IEC 17025, ISO 9001:2015, TUV, KHNP, AD2000, and ISO 80034 Ex Products System, for domestic and international locations., • Managing quality issues and customer complaints., • Facilitating root cause analysis, implementing problem appropriate corrective and preventive actions., • Conducting internal and supplier audits against appropriate standards and guidelines., • Hosting UL/ETL routine inspections and handling issues that arise., • Coordinating with Calibration Lab Managers on quality and equipment needs and issues., • Routinely auditing calibration activities for potential process deviations., • Developing and maintaining uncertainty budgets for the calibration laboratories., • Developing, monitoring, and maintaining repeatability and proficiency tests used for trend analysis., • Designing and evaluating standard operating procedures for calibration asset management software and uncertainty software for laboratory calibration standards and customer calibration events., • Assisting Engineering with the evaluation of new calibration methods and procedures., • Using statistical techniques to analyze and validate measurement standards and processes., • Ensuring that intermediate checks are performed on calibration standards,, • Authorizing short term extension of intervals on HYTORC standards when requested and to meet HYTORC needs based on valid reasons for interval extension or end of period reliability data., • Supervising the laboratory’s inter-laboratory proficiency testing program and ensuring it is maintained., • Providing training on all QMSs, including re-verification of all personnel as necessary to maintain confidence in tests and/or calibrations performed., • Providing leadership and guidance to the Quality and other departments., • Coordinating with HYTORC’s service department to support actions associated with customer feedback., • Compliance Team (2 Associates), • Additional resources may be added over time as we grow, and needs identified Education/Experience Required • Bachelors degree in a technical field or 8 plus yrs of related experience, • ISO/IEC 17025 (minimum of 5 years’ experience). Experience in calibration and metrology for force/torque and pressure., • ISO 9001:2015 (minimum of 5 years’ experience)., • Three years of experience supervising and managing personnel., • Must be able to understand and interpret statistical data and read drawings, • Excellent communication skills to interface with the customer (internal and external) and with all levels within the organization., • Excellent problem-solving skills., • Microsoft Excel, Word and PowerPoint., • SAP and/or other ERP Systems Physical Demands/Requirements • Ability to lift 30 lbs. with assistance., • Ability to travel domestically and internationally up to 40% of the time. Work Environment: Office, Warehouse, and Labs. The actual base salary a successful candidate will be offered will vary based on factors relevant to the position, as well as geography of the selected candidate. The salary range for this role is $110,000 - $125,000. The actual base salary a successful candidate will be offered within this range will vary based on factors relevant to the position. #LI-GC1 #ZR Company DescriptionIndustry leader with great innovation.Industry leader with great innovation.

Job DescriptionOn-site Interpreter (Independent Contractor) Baystate Interpreters, Inc. is seeking dedicated and professional interpreters to join our team as 1099 independent contractors. In this vital role, you will facilitate communication in various settings, enabling effective interactions in education, medical, legal, and community environments. Our ideal candidates are flexible, reliable, and possess a keen understanding of the cultural nuances involved in interpreting. This position offers competitive per diem rates and the opportunity to broaden your skill set, particularly in specialized fields such as medical and legal interpretation. About Us At Baystate Interpreters, Inc., we are bridging communication gaps by offering precise and dependable language services anytime, anywhere through innovative solutions. Founded in 2001, Baystate Interpreters, Inc. provides essential interpreting and translation services that improve the lives of the communities we serve. We accomplish this by ensuring comprehensive language access in over 350 languages, serving more than 2,200 clients with a diverse, highly skilled team and a network of experienced contract interpreters. Excellence in interpretation is key to our collective success, and it is achieved by partnering with the most skilled and highly qualified interpreters in the industry. Our commitment to quality and interpreter training can help you jumpstart your career as an interpreter today! Key Responsibilities: • Adhere to all Baystate Interpreters, Inc. policies related to information security and confidentiality including but not limited to HIPAA, FERPA, GLBA, and other relevant regulatory requirements., • Provide accurate on-site interpretation between English and designated target languages., • Follow interpreter protocols and procedures as required by Baystate Interpreters, Inc. and respective clients., • Follow all interpreter ethics standards, including those set by the IMIA (International Medical Interpreters Association), the National Council on Interpreting in Health Care (NCIHC), the American Translators Association (ATA), the National Association of Judiciary Interpreters and Translators (NAJIT), and the International Organization for Standardization (ISO). Uphold principles of confidentiality, accuracy, impartiality, professionalism, and cultural competence in every assignment., • Establish and maintain positive, professional interactions with patients, customers, healthcare providers, and clinical staff., • Continuously improve specialized vocabulary and subject matter knowledge (e.g., medical, legal, social services) to meet client needs., • Demonstrate professionalism, neutrality, and confidentiality throughout the interpretation process., • Provide high-quality interpretation, ensuring no omissions or additions, while adhering to established industry standards., • Exhibit strong interpersonal skills and customer service while assisting clients during sensitive interactions., • Must be legally authorized to work in the U.S., • Must be 21 years of age or older (in compliance with applicable legal and contractual requirements for this role.), • Proficiency in English and at least one additional language., • Strong communication skills and a composed demeanor in challenging situations., • Flexibility and reliability to meet the demands of per diem assignments., • Excellent listening, retention, and note-taking skills for accurate interpretation., • Familiarity with HIPAA and confidentiality regulations., • Competitive pay: Starting at $25.00 per hour (with potential for higher rates based on experience and specialization)., • Flexible scheduling: Accept assignments that fit your availability.

Job DescriptionThis is a temporary 6-month contracted 1099 position with no benefits. Job Functions: • Applies expertise as an emerging authority in the mechanical engineering discipline., • Conceives and develops solutions to difficult analytical and pneumatic/mechanical/electrical design problems., • Participates in establishing system or component design objectives and writes portions of complex specifications and engineering reports., • Reviews and helps to develop product specifications, • Conducts conceptual design studies using MCAD and other applicable design tools. Collaborates with other engineering functions, • Develops prototype hardware using internal manufacturing resources and outside vendors, • Tests product to verify that designs meet specification requirements such as environmental, regulatory and safety requirements, • Generates documentation supporting the design, • Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software., • Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable., • Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable., • Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data., • Experience with electronic document control systems in medical device and/or medical equipment design and development., • Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis., • Ability to create and meet scheduled timelines (manage and coordinate tasks as required)., • Ability to work in a team environment., • Strong communication skills., • Familiarity with dimensioning and tolerance, thermal and structural analysis, and vibration testing/analysis, • Intermediate knowledge of FDA, IEC and UL standards relating to medical electronic equipment, • Strong technical and analytical ability, verbal and written communication skills, ingenuity and creativity, interpersonal and project management skills, • Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM’s and oscilloscopes, • BSME or MSME and a minimum of 10 years of related experience in design/product development of electro pneumatic assemblies including technical supervision of sub-projects, • Formal training in basic and advanced topics in Solid Works is strongly preferred, • Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat, • Advanced proficiency with SolidWorks, MCAD/CAE software and database management software preferred, • Advanced proficiency with Microsoft Visio and Microsoft Project preferred Important Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to . Powered by JazzHR brNqS9xPBq

Job Description Company Overview: Samsung SDS America (SDSA), the IT and innovation hub of Samsung, delivers innovative cloud, AI, digital logistics, cybersecurity, and enterprise solutions to transform the way businesses work and operate. We serve Fortune 500 companies across industries and are driving digital transformation with cutting-edge technologies and trusted services. Position Summary: Samsung SDS America is seeking a Managed Cloud Infrastructure Services Team Leader is a leadership role with full budget ownership, responsible for the strategic direction, delivery excellence, and operational performance of managed cloud services across multi-cloud platforms (SCP, AWS, Azure, GCP). This role leads cross-functional teams—including CloudOps, SecOps, DataOps, and DevOps—and builds strong partnerships with hyperscalers and technology partners. The ideal candidate drives innovation, supports GTM enablement and business development, ensures cost-effective and compliant service delivery, develops talent, and aligns services to evolving client needs and market demands. You will work closely with executive leadership, customers, and cross-functional product, engineering, and sales teams to ensure we are delivering high-performance, cost-effective, scalable, and secure cloud services. The ideal candidate brings a strong background in data center, cloud infrastructure and operations, a strategic and business-oriented mindset, and a passion for building and leading high-performing teams. This is an onsite position based in Ridgefield Park, NJ. Responsibilities: Leadership & Strategic Execution • Develop and execute a future-proof strategy for managed cloud services aligned to market trends, client needs, and innovation opportunities., • Lead a multi-disciplinary team and foster a culture of accountability, agility, and continuous improvement., • Build partnerships with hyperscalers, ISVs, and ecosystem players to enhance value delivery and joint go-to-market efforts., • Direct end-to-end delivery and operations across Data Center, Samsung Cloud Platform (SCP), AWS, Azure, and GCP., • Ensure high availability, scalability, security, and cost efficiency across cloud workloads., • Implement DevOps, SRE, and automation-driven operating models to drive consistency and speed., • Monitor SLAs, KPIs, and service health metrics to maintain transparency and exceed client expectations., • Lead strategic partnerships to enhance service capabilities and co-develop joint offerings with cloud technology partners., • Manage budgeting, forecasting, and service cost-effectiveness through collaborative planning., • Drive cost efficiency and innovation without compromising service quality., • Attract, retain, and develop top talent across cloud engineering, operations, and architecture functions., • Build internal capabilities through structured training, knowledge sharing, and mentoring., • Promote a high-performance team culture with cross-regional collaboration, especially with counterparts in Korea HQ., • Lead internal stakeholder and client conversations as a trusted advisor for cloud operations and transformation. Requirements • 12+ years of experience in IT infrastructure and operations, with at least 5 years in cloud services leadership roles., • Proven track record of owning and driving budget for cloud or managed services portfolios., • Deep expertise in multi-cloud environments (AWS, Azure, GCP) and hybrid architectures., • Strong background in DevOps/SRE principles, automation, and infrastructure as code (IaC)., • Demonstrated success in building scalable service delivery and operations teams in global or matrixed organizations., • Experience leading strategic partnerships with hyperscalers, ISVs, or cloud ecosystem players., • Strong understanding of security and compliance standards (SOC2, ISO, HIPAA, etc.)., • Business acumen to translate technical operations into measurable business value and client impact., • Excellent executive communication, people leadership, and stakeholder engagement skills., • Must be eligible to work in the US for any employer without restrictions., • Must be able and willing to work onsite in Ridgefield Park, NJ. Samsung SDSA offers a comprehensive suite of programs to support our employees: • Top-notch medical, dental, vision and prescription coverage, • Wellness program, • Parental leave, • 401K match and savings plan, • Flexible spending accounts, • Life insurance, • Paid Holidays, • Paid Time off, • Additional benefits Samsung SDS America, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, status as a protected veteran, marital status, genetic information, medical condition, or any other characteristic protected by law. We are committed to providing reasonable accommodations to participate in the job application or interview process for candidates with disabilities. Please let your recruiter know if you need an accommodation at any point during the interview process.

Job Description Sr. Auditor Quality Assurance (Pharmaceuticals) Location: Paramus, NJ (100% On-Site) - 5 month contract Experience Level: Mid-Senior Experience Required: 5+ Years Education Required: Bachelors Degree (Life Sciences or related field) Industry: Pharmaceuticals / Life Sciences Job Function: Quality Assurance / Auditing / Compliance Compensation: Hourly Competitive (rate provided upon request) ️ Relocation Assistance: Not Provided Visa Sponsorship: Not Available Position Summary We are seeking a Senior Quality Assurance Auditor with strong experience in the pharmaceutical or radiopharmaceutical sector. This role is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with GMP, GDP, and other global regulatory standards. The successful candidate will play a critical role in upholding our Pharmaceutical Quality System (PQS) and ensuring inspection readiness across operations. Key Responsibilities * Conduct internal audits, supplier audits, and contract manufacturer (CMO) audits including routine, for-cause, and risk-based. * Develop and manage audit plans, schedules, and checklists based on regulatory guidelines and internal SOPs. * Assess compliance with FDA, EMA, ICH, and international GMP/GDP regulations. * Review and evaluate deviations, CAPAs, and change control records. * Generate detailed audit reports and communicate findings to internal and external stakeholders. * Track CAPA implementation and verify effectiveness through follow-up assessments. * Support regulatory authority inspections and third-party audits. * Provide expertise on quality and compliance-related matters, promoting audit readiness culture. * Identify systemic gaps, recommend improvements, and drive continuous quality improvement initiatives. * Stay current on regulatory changes, industry trends, and quality system best practices. Required Qualifications Bachelors degree in Life Sciences, Pharmacy, or a closely related field 5+ years of pharmaceutical QA experience (with at least 2 years conducting audits) Proven understanding of GMP, GDP, and radiopharmaceutical (RPT) compliance Familiarity with global regulations including FDA, EMA, ICH Excellent documentation, communication, and analytical skills Ability to travel up to 10% for audits (domestic and potentially international) Preferred Certifications ASQ Certified Quality Auditor (CQA) ISO 9001 Lead Auditor Certification GCP/GMP Auditing Certifications Why You Should Apply If you're looking to leverage your audit and compliance skills in a growing, highly specialized sector like radiopharmaceuticals, this role offers the ideal opportunity. You'll work in a critical QA function with visibility across manufacturing, testing, and supply chain operations, helping to uphold product integrity and patient safety. This is a high-impact position where your attention to detail and regulatory expertise will directly contribute to maintaining compliance, improving systems, and supporting global quality standards. Whether you're looking to step into a senior auditing role or expand your influence across a broader QA landscape, this opportunity provides the structure, challenge, and responsibility to help elevate your career. Apply now to join a team committed to excellence in pharmaceutical quality and make a difference in the future of healthcare.

Job DescriptionQuality Control Microbiology Analytics I, II, III QC Microbiology Analyst I The Quality Control Microbiology Analyst I serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst I will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. This position will report into the Manager of QC Microbiology. • Environmental monitoring in controlled environments: Non-viable particulate monitoring; Active viable air monitoring, Personnel monitoring, Surface sampling, Passive air monitoring, • Equipment monitoring: Ensure equipment is in proper working conditions; Ensure all equipment is properly; maintained/calibrated; Assist with routine laboratory testing; Plate reads and incubations, • Shipping of test samples and equipment to contract laboratories for testing, • Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).REQUIREMENTS, • Associates degree in a science or relevant field required; Minimum 0-2 years of experience or equivalent experience. Environmental monitoring or within the biopharmaceutical industry experience preferred., • Proficient with computer software such as; Microsoft Office, • Strong written and oral communication skills, • 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 responsibilities, • Trained in GxP/GDP, Safety, • The QC Microbiology Analyst I must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • 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 company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. QC Microbiology Analyst II The Quality Control Microbiology Analyst II serves as a support role to clinical and commercial production. Microbiology Analyst II will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. This position will report into the Manager of QC Microbiology., • Environmental monitoring in controlled environments; Non-viable particulate monitoring, Active viable air monitoring Personnel monitoring, Surface sampling, Passive air monitoring, • Equipment monitoring; Ensure equipment is in proper working conditions, Ensure all equipment is properly maintained/calibrated, Program equipment with proper workflows, Assist with routine laboratory testing, Plate reads and incubations, • Shipping of test samples and equipment to contract laboratories for testing, • Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Writing/conducting investigations pertaining to environmental monitoring and testing, • Develop and train QC Microbiology Analyst I personnel on relevant business processes.REQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry., • GxP/GDP, Safety Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, • Familiarity with ISO and EU standards, • Strong written and oral communication skills, • Technical training ability, • 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 company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • 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. QC Microbiology Analyst III The Quality Control Microbiology Analyst III serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst III will coordinate data for batch release, participate in project/client meetings, and author/revise environmental monitoring procedures. Additionally, the QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring., • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Analyst II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work ordersREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • GxP/GDP Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experience, • 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 responsibilities, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityWorking Environment, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • 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 clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityPhysical Requirements, • The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • Must be physically capable to stand; walk; site; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear., • Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator.Please note these job descriptions are 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 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 DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionThis is a temporary 6-month contracted 1099 position with no benefits. • Interprets customer specifications to define requirements for mechanical designs., • Performs first principal analysis related to appropriate aspects of mechanical design., • Applies the 3D CAD system to create mechanical design and drawings., • Develops detailed fabrication and assembly drawings and performs tolerance analysis., • Develop prototypes for design evaluation., • Troubleshoot and resolve design & processing issues., • Contributes to details of design documentation using electronic documentation systems., • Collects, analyzes and interprets data to propose recommendations., • Develops & execute design verification protocols and technical reports., • Work with internal and external resources on fabrication, inspection, and testing of new product parts and assemblies., • Develop & debug prototype tooling / equipment and processes., • Develop test methods and fixtures., • Formulate plans & methods to accomplish assignments with appropriate oversight., • Works independently and prioritizes assigned tasks with guidance., • Contribute to project planning activities., • Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software., • Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable., • Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable., • Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data., • Experience with electronic document control systems in medical device and/or medical equipment design and development., • Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis., • Ability to create and meet scheduled timelines (manage and coordinate tasks as required)., • Ability to work in a team environment., • Strong communication skills., • Competent in use of Microsoft Office tools., • Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM’s and oscilloscopes., • Familiarity and the ability to operate basic shop equipment such as hand tools, a drill, and Dremel., • Understand & interpret simple wiring diagrams., • BS in engineering discipline, mechanical preferred., • Minimum 2-4 years related experience, or an MS and less than one year experience., • Experience with a solid modeling CAD program, preferably Solidworks., • Experience in medical equipment / device design with experience in electromechanical, electro-pneumatic, and/or blood pumping equipment development., • Knowledge in medical device industry regulations and practices – ISO 13485, ISO 7198 & GMP., • Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat., • Experience with Microsoft Visio and Microsoft Project preferred.#LI-RS1 Important Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to . Powered by JazzHR c1QYkE11NQ

Job Title: Instrumentation Control Technician Location: Lyndhurst, NJ Type: Contract To Hire Compensation: $33 - $36 hourly Contractor Work Model: Onsite Hours: Monday through Friday (6AM to 230PM) Responsibilities: Analyze, document, and test computer control systems based on user specifications and operating requirements. Develop, test, and document computer programs related to machine control and operating systems. Perform maintenance, troubleshooting, and calibration of instrumentation and control devices to ensure accuracy and reliability. Manage the calibration program, including scheduling, performing calibrations, and maintaining records in Calibration Manager Software in compliance with ISO 9000 standards. Support the maintenance and repair of labeling equipment, electrical systems, and electronic devices. Apply systems analysis techniques and collaborate with end users to identify and resolve control system needs. Provide weekend or on-call support as needed for troubleshooting and plant operations. Qualifications / Experience: 5–10 years of experience in an ISO 9000 or process-type industrial facility (chemical, pharmaceutical, or food industry preferred). Minimum 1 year of relevant experience with Technical School training; college degree a plus. Strong electrical background with hands-on experience in computer systems, PLCs (Allen-Bradley preferred), and pneumatic/hydraulic devices. Familiarity with CMMS software and smart instruments is a plus. Skilled in analyzing, testing, and troubleshooting with an organized, methodical approach to problem-solving. Ability to read and interpret technical drawings (P&IDs) and ladder logic diagrams. Proficient in performing instrument calibration and preventive maintenance. Strong communication skills and the ability to work independently or as part of a team. System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M1 Ref: #562-Joule Staffing - Edison

Job Description We are seeking a Quality Assistant to join our team! You will conduct tests to determine the quality of materials and finished products as well as identify areas of improvement to increase efficiency. A Key function will be completing, reviewing and approving first article inspection reports. Full or Part Time Opportunities Available. Responsibilities: • Perform thorough examinations of all materials and finished products, • Ability to interpret the blueprint and its requirements., • Excellent record keeping ability, • Understanding of tolerances, • Ability to interpret the blueprint and its requirements., • Understand customer expectations, • Train and assist quality team for the technical information, • Verify Compliance to drawing requirement when necessary, • Excellent record keeping ability, • Thorough understanding of the tolerances, • Ability to interact with other departments such as production and engineering team, • Assist upper management when necessary, • Assist in investigating and correcting quality related issues including customer complaints, • Participate in customer audits and inspections and corrective action reports, • Perform other duties directed by Quality Management, • Verify internal and external FAI documents for accuracy, and completeness, • Prioritize inspection task to meet customer due date requirement, • Finalize FAI reports , review and prepare for submission, • Prepare final inspection reports as required and organize for future reference, • Conduct and report internal audits and evaluations, • Implement and improve quality control operating procedures, • Participate in routine visual inspections, • Previous work experience in quality control or other related fields, • AS9100 and ISO 9001 Experience a plus, • Strong attention to detail, • Strong analytical and critical thinking skills

HCLTech is looking for an expert in payments domain with BA (Bilingual) and data analysis skill sets they should be familiar with payment types formats industry standards data mapping to join it in advancing the technological world through innovation and creativity. Job Title: Payments BA - BILINGUAL Job ID: 2779793 Position Type: Full-time Location: Jersey City, New Jersey Onsite Key Responsibilities: • Relevant experience as business DATA analysis, business analysis or system analysis., • Experience in data governance data management or related roles including support of data standards/policies., • At least 5 plus years of experience in banking and financial services industry preferably payments, • Experience with data management processes tools and applications including data cataloging process mapping handling data quality issues and lineage tool sets., • Experience in data profiling and writing SQL queries., • Ability to communicate both verbal and written in a clear confident with wide variety of stakeholders at different levels. Required Experience • Define business, financial, and operations requirements and systems goals through partnership with decision makers, systems owners and end users, • Strong knowledge and hands-on experience of working on industry standards like ISO20022, SWIFT etc., • Proficient in gathering the business requirements and converting those into technical & functional solutions, • Deep understanding of multiple payment ecosystems (UPI, US RTP, FedNow, SEPA Interac etc), regional payment practices and emerging solutions, • Solid understanding of trends in payment industry such as Mobile Banking, Digital Wallets, Tokenization, • Successfully completed projects involving digital transformation and migration of legacy payment systems, • Define & document User Stories, ICDs in JIRA under appropriate epic, • Provide solution, story & ICD walkthrough to partners, Engineering Managers and CQE teams, • Work with Scrum Masters & RTEs for day to day execution of initiative via a scrum team, • Qualifications:, • Demonstrated ability to effectively use complex analytical, interpretive and problem-solving techniques, • Proven interpersonal, diplomatic and influencing skills, • Consistently demonstrate clear and concise written and verbal communication Must have skills: • Knowledgeable on SWIFT MT, • Knowledgeable On MX (ISO 20022), • Hands on experience on CLEARING & SETTLEMENTS OF PAYMENTS between banks, • PACS.008 (transfer funds from a debtor's account to a creditor's account between 2 FI), • PACS.009 (FI Credit Transfer), • PACS.004(Payment Return), • PACS.009COV (FI ‘Cover’ Credit Transfer), • Business requirements writing and converting those into technical & functional solutions, • JIRA Tool, • Clear written and verbal communication Pay and Benefits Pay Range Minimum: $ 66000 year Pay Range Maximum: $ 136400 per year HCLTech is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to for investigation. Compensation and Benefits: A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.

Summary of Responsibilities We are seeking an experienced and proactive Information Technology Manager (Network Services) with a strong background in cybersecurity to lead the design, implementation, and management of our network and assist in cyber security initiatives. Reporting to the Senior Director, Technology Strategy and Operations, this position will play a role in maintaining a secure, reliable, and scalable environment that supports business operations and protects against evolving cyber threats. The ideal candidate will be both technically hands-on and strategically minded, with experience managing teams, vendors, and network security initiatives. Essential Functions • Oversee the integrity and robustness of network systems to ensure seamless operation and support for our business objectives. This includes overseeing the daily operations of LAN/WAN environments, firewalls, wireless networking systems., • Design and implement high-availability network architecture to support business continuity and facilitate growth., • Monitor network performance and troubleshoot issues to ensure optimal performance and uptime. Manage and deploy Intune for enhanced device and application management., • Collaborate with the cybersecurity team to enforce network security policies and controls, ensuring robust protection against threats, • Manage firewalls, intrusion detection and prevention systems (IDS/IPS), and implement network segmentation strategies., • Ensure compliance with regulatory requirements (e.g., NIST, ISO 27001, SOX, and others as applicable)., • Conduct regular risk assessments, vulnerability scans, and develop remediation plans for network assets., • Actively participate in strategic IT planning initiatives and contribute to the development of infrastructure roadmaps., • Assist in the management of vendor relationships, oversee IT contracts, and assist in facilitating the procurement processes for network and security technologies., • Work alongside the team to develop and maintain comprehensive network documentation, diagrams, and standard operating procedures (SOPs)., • Take the lead in managing and responding to network-related incidents and facilitate post-incident reviews to enhance our response strategy., • Establish robust logging, monitoring, and alerting mechanisms for early detection of threats., • Assist in Disaster Recovery (DR) and Business Continuity Planning (BCP) activities to ensure operational stability during disruptions. Job Requirements • Bachelor’s degree in Computer Science, Information Technology, or related field or similar is required or four (4) years directly related professional experience may be accepted in lieu of a bachelor’s degree, in addition to the (5) years’ experience required below., • Minimum of 5 years of experience in a network security or cybersecurity focused role., • Professional certifications: CCNP, CISSP, CISM, Fortinet NSE, or equivalent is preferred., • Experience in network administration and architecture is preferred., • Experience in network security or cyber security is preferred., • Deep understanding of physical and virtual firewall architecture is preferred., • Strong understanding of Intune, Azure EntraID platform, TCP/IP, routing protocols (BGP, OSPF), VLANs, DNS, DHCP, and SD-WAN is preferred, • Familiarity with security frameworks (e.g., NIST, CIS Controls, Zero Trust architecture) is preferred., • Hands-on experience with firewall rule design, VPNs, and NAC (Network Access Control) is preferred. Compensation & Benefits • Competitive Salary, • Medical, Prescription, Dental, Vision Benefits subject to employee contributions, • Medical and Dependent Care Flexible Spending Accounts, • Life Insurance, • Commuter Benefits, • 401(a) Retirement Plan (6% of employee’s salary funded by GDC), • 457(b) Retirement Plan – (Pre-Tax Salary Contributions Elected by Employees), • Earned Vacation (20 days per year) and Sick Time (12 days per year), • Paid holidays

Business Integration Partners (BIP) is Europe’s fastest growing digital consulting company and are on track to reach the Top 20 by 2030, with an expanding global footprint in the US. Operating at the intersection of business and technology we design, develop, and deliver sustainable solutions at pace and scale creating greater value for our customers, employees, shareholders, and society. BIP specializes in high-impact consulting services across multiple industries with 6,000 employees worldwide. Our domains include Financial Services business serves Capital Markets, Insurance and Payments verticals, supplemented with Data & AI, Cybersecurity, Risk & Compliance, Change Management and Digital Transformation practices. We integrate deep industry expertise with business, technology, and quantitative disciplines to deliver high-impact results for our clients. BIP is currently expanding its footprint in the United States, focusing on growing its Capital Markets and Financial Services lines. Our teams operate at the intersection of business strategy, technology, and data to help our clients in driving smarter decisions, reducing risks, and staying ahead in a fast-evolving market environment. About the Role: The Software Engineer will contribute to the design, development, and enhancement of core payments and wire processing applications within our corporate and investment banking client’s technology organization. Engineers will work across distributed systems, real-time transaction pipelines, settlement engines, and compliance/monitoring platforms supporting high-volume, low-latency financial operations. You must have valid US work authorization and must physically reside around the posted city, within a 50-mile commute. We are unable to support relocation costs. Please do not apply for this position unless you meet the criteria outlined above. Key Responsibilities: • Develop and maintain services supporting high-volume payments, wire transfers, and money movement workflows., • Build scalable applications using Python, Java, or .NET across distributed environments., • Implement integrations with internal banking platforms, payment rails, and ledger systems., • Troubleshoot production issues, improve resiliency, and reduce latency across transaction flows., • Contribute to modernization efforts, including cloud migration, refactoring legacy components, and API enablement., • Collaborate closely with BAs, architects, PMs, and offshore/nearshore teams., • Follow secure coding standards, operational controls, and SDLC processes required by the bank. Required Skills: • 3–10+ years hands-on experience in Python, Java, or C#/.NET., • Experience with relational databases (Oracle, SQL Server)., • Understanding of payments, wire transfers, clearing systems, or financial services workflows., • Familiarity with distributed systems, messaging, and event-driven architectures., • Strong debugging and production support experience., • Understanding of CI/CD and Agile environments. Preferred Skills: • Hadoop / Informatica ecosystem knowledge., • Experience with ISO 20022, SWIFT, Fedwire, CHIPS., • Microservices architecture, REST/gRPC APIs., • Performance tuning and low-latency engineering. The base salary range for this role is $125,000 - $175,000 Benefits: • Choice of medical, dental, vision insurance., • Voluntary benefits., • Short- and long-term disability., • HSA and FSAs., • Matching 401k., • Discretionary performance bonus., • Employee referral bonus., • Employee assistance program., • 11 public holidays., • 20 days PTO., • 7 Sick Days., • PTO buy and sell program., • Volunteer days., • Paid parental leave., • Remote/hybrid work environment support. For more information about BIP US, visit ___. Equal Employment Opportunity: It is BIP US Consulting policy to provide equal employment opportunities to all individuals based on job-related qualifications and ability to perform a job, without regard to age, gender, gender identity, sexual orientation, race, color, religion, creed, national origin, disability, genetic information, veteran status, citizenship, or marital status, and to maintain a non-discriminatory environment free from intimidation, harassment or bias based upon these grounds. BIP US provides a reasonable range of compensation for our roles. Actual compensation is influenced by a wide array of factors including but not limited to skill set, education, level of experience, and knowledge.

Roles & Responsibilities: Expert knowledge of quality management systems (QMS), compliance standards (FDA, ISO etc) and risk management. Understanding client quality management needs and map business requirements to EtQ Reliance capabilities. NC, CAPA, Audit Management, Change Control, Complaints).