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Overview Join our team as a night shift, full time, Emergency Room (ER) Registered Nurse in Westwood, NJ. Why Join Us? Thrive in a People-First Environment and Make Healthcare Better • Thrive: We empower our team with career growth opportunities, tuition assistance, and resources that support your wellness, education, and financial well-being., • People-First: We prioritize your well-being with paid time off, comprehensive health benefits, and a supportive, inclusive culture where you are valued and cared for., • Make Healthcare Better: We use advanced technology to support our team and enhance patient care., • The RN Staff Nurse functions as a caregiver for a specific patient population in order to achieve desired outcomes., • This position directs and oversees the care provided by other caregivers through delegation, validation, evaluation, and coordination., • This position effectively coordinates patient care/unit activities among nursing peers, physicians and support services. Job Requirements: • Graduate of a NLN/AACN accredited program in nursing., • 2 years experience, • Experience with electronic health records a plus, • Current valid NJ State Professional Registered Nurse license., • BLS certification must be obtained within 14 days of hire or transfer into the role and prior to providing direct patient care., • Advance Cardiac Life Support certification (ACLS), • Pediatric Advance Life Support ( PALS)

Job DescriptionQuality Control Analytical Associate IIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. Under the direction of the Manager, QC Analytical Associate II, responsibilities include: • Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations, • Performs maintenance, monitoring, and troubleshooting of pertinent equipment, • Performs and assists in the training of other Quality Control technicians, • Maintains training records and coordinates records retention with Document Control and Training groups, • Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines, • Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable, • Participates in managing QC materials and supplies, • Performs and assists in equipment and method qualification/validation activities as needed, • Performs reagent and media preparation, • Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment, • Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results, • Initiates, investigates, and prepares deviation reports with input from assigned supervisor, • Brainstorms and implements corrective and preventive actions, as and when applicable, • Documents training and execution of shipping test samples to contract laboratories for testing, • Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Communicates effectively with other co-workers, departments, management and clients, • Eventually serves as a lead and/or co-lead for client projects, • Additional tasks as assignedREQUIREMENTS, • BA/BS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred, • Prior industrial experience in cell count methodologies preferred, • Prior academic and/or industrial cell therapeutic experience preferred, • Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry, • Proficient with computer software such as: Microsoft Office, Visio, • Strong written and oral communication skills, • Strong presentational skills preferred, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.Other Information, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately 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 facility, • The QC Analytical Associate II must be able to work in a laboratory environment for an extended period., • Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hearPlease 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. QC Analytical Associate I is available as well.

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. Japan. Job Summary: Responsible for the management and execution of various aspects of translational and early-stage clinical studies (implementation, site selection, patient recruitment, vendor selection and oversight, tracking clinical data, etc.) for global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. This is a hybrid position that requires to be in the Paramus office twice a week. Essential Duties and Responsibilities: • Develop and deliver program level translational and early-stage clinical drug development strategy, • Design, plan and execute biomarker strategies to inform indication priorities, commercial differentiation, regulatory strategies, biomarker qualification plan, and that achieve biomarker-driven milestones, such as target engagement, measurement assay development and validation, pharmacodynamic activity, and other biomarker contexts of use in clinical-stage programs, • Integrate with colleagues in discovery research and research-stage project teams to identify translational biomarkers and demonstrate preclinical target engagement, methodology of detection and measurement, proof-of-mechanism, pharmacodynamic activity, PK/PD relationships., • Plan, implement, manage and report for regional or global clinical studies., • Manage and Lead selection process of CROs for regional or global clinical studies., • Direct, oversight and manage the performance of study vendors (e.g. CROs and central labs)., • Provide direction and guidance with the Clinical Lead to achieve project objectives., • Manage and resolve project performance issues (issue management) if they arise., • Manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans., • Responsible for the creation of study related documentation (protocol, ICF, CRF, operations manuals etc.)., • Tracking clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans., • Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols., • Manage negotiation of clinical trial contracts between investigational sites and CROs., • Oversight of data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan., • Responsible for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites., • Implement project specific training program and training materials, • Create and maintain clinical SOPs and TMF as part of global QMS and TMF processes., • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, NS Pharma Japan (HQ), external partners and vendors., • Experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets., • Good cross-functional team leader who fosters team spirit and team motivation (teamwork), • Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies., • Ability to anticipate and timely escalate issues and to define appropriate action plans, • Decision-making and problem-solving skills, • Ability to handle multiple tasks and prioritize, • Strong organizational, communication and presentation skills, • PhD and/or MD with 8+ years of experience in pharmaceutical or biotech R&D. MS or BS with 12+ years of R&D experience with progressive levels of team leadership also considered., • Preference for those with 5+ years’ experience as a Translational lead for clinical programs. Experience with Ph2/3 or registrational programs desired., • Excellent understanding of drug development, regulatory processes and clinical development NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $175,000 to $220, 000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training NS Pharma is an EEO employer.

Job Description Our client in Fairfield, NJ is looking for a Validation Engineer for a Full time position. Pay is $80k-$95k annually DOE • Requires a 4-yr engineering degree or substitute experience; a graduate degree in engineering, technical, or management discipline is preferred., • Minimum of 5 yrs. (equivalent) experience in product quality position, with direct experience PPAP/Validation Deliverables., • Experience in the medical device/ (GxP) industry is required., • Validation (IQ, OQ, PQ) or PPAP (Production Part Approval Process) required, • Must have knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance Benefits: The company offers a competitive benefits package that includes medical, dental, vision, 401k, pet insurance, etc... Company DescriptionPrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company.PrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company.

Job DescriptionTitle: Quality Assurance (QA) Supervisor Reports to: Quality Manager or Head of Quality Department: Quality Assurance Responsibilities: • Oversee Quality Systems Modules for compliance (Change Controls, Deviations, Discrepant Materials, Returns, Supplier Issues, etc., • Support Investigations (e.g. non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups)., • Train and supervise document control/review personnel; batch release personnel, accurate record of approved, quarantined, rejected products., • Lead the review, release and compliance of materials, FG, bulk and intermediates where applicable, to support customer requirements., • Support audits, inspections and ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, HC, EPA, OSHA, ISO 13485:2016)., • Familiar with US FDA OTC drug regulations, including data integrity requirements., • Maintains a working knowledge of QA inspection requirements for components, raw materials, in-process/bulk and finished goods., • Ensures that review of in-process activities in both Manufacturing and Warehouse areas is conducted by QA inspectors for conformance to specifications; follow up on out-of-specifications including non conformances., • Participates in In-process Quality in-house and outside training program., • Conducts periodic analysis of In-process Inspection program for pre-weigh and bulk manufacture and makes recommendations., • Assist in interpreting and/or developing of customer specifications and requirements for approved formulas., • Assists in establishing production and assembly inspection information sheets and documentation as required., • Maintains and updates ERP System, maintains repository of batch records/documents, and other Mfg & Assembly in-process Specifications., • Reviews of batch records, work sheets, and Inspection documentation for completeness and correctness., • Support non-conformance resolutions, complaint investigations, and associated corrective and preventative actions., • Reviews of QA Inspection reports daily for correctness and completeness., • Facilitates on site customer inspections, coordinating availability of product and communication of disposition to Quality and Inventory Control. Interfaces with customer distribution operations where needed., • Maintains awareness and compliance with safety regulations in performing job duties., • Ensure that finished goods, bulk, raw materials, components are maintained correctly in the warehouse and other holding areas., • Assist in the review and release of bulk and finished products, when applicable., • Perform supplier and vendor audits, as well as, Mock recall and internal audits., • Support Process Validation and Cleaning & Sanitization Validation activities under the quality systems to ensure compliance., • Support formal drug stability program, bulk hold studies, and product compatibility by co-ordinating samples submission, testing, result retrieval and program review., • Maintains files and database of customer-approvals and documents as evidence of authenticity., • Effects changes to specification sheets as approved through proper change control requests., • Support Change Control Requests for Customer requested changes to raw material, intermediate/bulk, FGs, specifications., • Maintains copies of approved change controls as applicable to product specification updates/revisions., • Under the supervision of Quality Manager, review and approved formulas, specifications and procedures., • Communicates new and updated SOPs to all employees at EWL. Qualifications: • Minimum of associate degree or bachelor degree (Life Sciences, Engrg, related profession)., • Three + years industry or related experience in cosmetic, device, food, or pharma., • Experience/Knowledge of US FDA OTC regulations - a plus., • Previous inspecting, auditing or manufacturing experience - a plus., • Data analysis, specification development skills., • Computer literate and effective communication skills., • Ability to lift and carry up to 10-15 pounds.Compensation & Benefits:, • Pay range: $60,000 - $65,000 per year, • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match obtLtIxvhl

Job Description Company Overview: NRS is a leading provider of transportation & supply chain management services, and a family-owned and operated company that has been providing smart logistics solutions for the world's leading retailers and manufacturers for 60+ years. Whether it’s NRT, Keystone, Keystone Fresh, or Keystone Capacity, our innovative energy drives us towards new and valuable solutions for our clients, even as we continuously grow and strengthen our network. We are dedicated to creating a culture that empowers the individual and offers our associates the opportunity to apply their unique skill to the challenges facing our clients. In the office, the warehouse, or on the road, it is this commitment to our innovative spirit that unites us in common mission to push boundaries in the logistics industry. Join our team at NRS, Inc. and contribute to our mission of providing exceptional transportation and logistics services. We offer a competitive salary and benefits package, and we are committed to providing our employees with a positive work environment and opportunities for growth and development. Apply now and be a part of our success story! This role is onsite and based in Lyndhurst, NJ. Job Overview: As a member of the Full Stack Development team within the Information Technology organization, the Application Developer II works closely with leading experts on our IT teams and across our business units to define, develop, maintain, modify, and support custom software solutions. This role plays a crucial part in ensuring our customers’ needs are met through the deployment and updates of business-critical solutions. Duties & Responsibilities: Leadership & Communication • Support and promote the company values, culture, and HR processes, • Analyze customer requirements to determine feasibility of design within time and cost constraints, • Consult with internal staff and external vendors to evaluate overall system performance and proactively identify areas for improvement, • Participate in project activities, providing status updates, resource estimates, and guidance on software solution scope and requirements, • Document all aspects of the software solution for future upgrades and maintenance, • Learn and apply NRS’s established standards for technology, tools, and techniques, • Maintain and improve existing codebases; peer-review code changes, • Provide solution support for escalated issues across all stages of the SDLC, • Use experience and industry knowledge to propose and evaluate new technologies that align with current and future business needs, • Build trust and strong working relationships with Technology and Business stakeholders, • Bachelor’s degree in Computer Science or related field, or equivalent practical experience, • Strong problem-solving skills and attention to detail, • Excellent organizational, interpersonal, and communication skills, • Strong business acumen and ability to adapt to change, • Continuous Learning — staying updated with emerging integration technologies and techniques • Back-end Engineering (Java + Spring Boot): 4–8 years – Production experience with Java 17/21 and Spring Boot 3+, building and maintaining REST/SOAP services; JSON/XML, pagination, versioning, concurrency, robust error handling. • API Integrations: 3+ years – End-to-end integrations via webhooks and polling; schema/data mapping and validation; file-based flows (CSV/XML/JSON over SFTP) when APIs aren’t available; translating vendor specs into production solutions. • Authentication & Security: 2+ years – OAuth2/OIDC, API Keys/HMAC, mTLS; input validation and audit logging; secrets and IAM hygiene with least-privilege access. • AWS Integration Stack: 2–4+ years – Hands-on with API Gateway (incl. VPC Link), Lambda or ECS/Fargate workers, SQS/SNS/EventBridge, Step Functions, Secrets Manager, CloudWatch/X-Ray; private connectivity to on‑prem/partner systems. • Data Layer & Performance: 3+ years – SQL (Postgres/MySQL/DB2), JDBC/JPA, query tuning and indexing, transaction boundaries; caching (Redis) and reliability patterns (outbox, idempotency, DLQ). • CI/CD & Quality: 3+ years – Git workflows and code reviews; JUnit 5/Mockito; Maven/Gradle; pipelines (Jenkins/GitHub Actions); safe deploys (blue/green or canary). • Stakeholder & Vendor Collaboration: 2+ years – Author mapping docs, test plans, and UAT scripts; clear communication with business partners and third-party vendors. Preferred / Nice to Have • IBM i (AS/400): DB2 for i via JDBC/ODBC, JT400, calling RPG programs, SFTP flat-file exchanges — 1+ year, • This position may require travel to various company locations on the East and West Coast, • Extended sitting: primarily desk-based with prolonged computer use, • Computer use: frequent operation of computers and office equipment, requiring manual dexterity, • Eye strain and repetitive motion: risk from continuous screen use and repetitive tasks like typing, • Office navigation: light walking and standing for meetings and tasks within the office NRS is an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #NRSIND

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

Job Description Job Description One of the nation’s largest independent testing facilities seeks a Stability and Study Coordinator with a minimum of 2 years stability systems experience in a GMP environment. The perfect candidate will also have previous experience as an Analytical Chemist with a minimum 2 years experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Must have the technical ability to understand client requirements, technical documentation, and be able to prepare testing protocols. Responsibilities include, but are not limited to the following: • Communicates with clients regarding studies to ensure timely processing and submission to the laboratories., • Entry of stability studies and all associated information into company software system and communicates the stability testing schedules to department management., • Performs time point pulls within the acceptable guidelines and documents details as per SOPs, customer and regulatory requirements., • Submission of the stability samples to the appropriate departments., • Develops and generates stability study protocols according to customer requirements and timelines, internal SOPs and regulatory requirements., • Compilation of time point raw data and verification of results entry into stability system as well as generation of interim and summary time point data and reports., • Prepares the generation of shelf life summary reports for products based on compiled data., • Coordinates with department management regarding stability workload and schedules to ensure timelines are met., • Preparation of sample shipments and paperwork for returned samples., • Entry of routine, development and validation studies and all associated information into company software system and communicates the study details to department management., • Documents work clearly and accurately., • Perform technical writing and peer review as needed, • Capable of working in a fast paced environment. Education and Experience • Bachelor's degree in chemistry or other related degree, preferred., • Minimum 2 years of stability systems experience in a GMP laboratory., • Minimum 2 years of product testing experience in a GMP laboratory., • ISO 17025 experience a plus., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Ability to stand/sit in office and laboratory environment., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Vision accuracy and color detection are required for this position, • Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc., • Ability to lift up to 30 lbs. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law. Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

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

Job Description Providing Engineering and Manufacturing solutions since 1955, Triangle specializes in the precision engineering and manufacturing of highly complex, tight-tolerance machined parts and assemblies. Triangle continues to thrive in more than 107,000 square feet over four state-of-the-art facilities at our Upper Saddle River, NJ campus. As a family-owned company, we foster a workplace that supports customer-driven, growth-oriented values and has a passion for surpassing expectations. We invest in our associates and create a supportive, team-based environment for learning, innovation, and advancement. Triangle is not only a family-run business; it's also a place where our associates feel like family. We believe in the same values and bring the same passion to our work each day to make a difference in people's lives. SUMMARY Responsible for the successful outcome of the development and implementation of the complete part-specific process by effectively translating the customer’s requirements to the company and suppliers, and adhering to the Quality Management System, all applicable regulations, and Lean Manufacturing principles. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. • Manages all aspects of the part-specific process, including resource planning, project timelines, and establishing priorities to ensure customer requirements and quoted standards are met., • Evaluates and improves process documentation protocols for engineering and manufacturing, as well as creates, updates, and maintains the item masters, bills of material, and routers, etc., • Reviews requests for quotes (RFQs) and helps determine the feasibility of projects, estimates labor and related costs, and prepares formal quotes for submission to customers., • Teams with customers to review designs for manufacturability and to understand the functionality of the part and its features, adds specifications as needed, and verifies GD&T was properly applied., • Clarifies, confirms, and correlates acceptance criteria with customers, company, and suppliers., • Develops manufacturing methods for new and existing projects by reviewing customer specifications and quality agreements, adhering to all applicable requirements, and effectively translating them into instructions., • Performs initial sourcing and qualifies suppliers from a technical perspective, as well as effectively communicates the customer requirements through training and auditing of the supplier’s performance on a regular basis., • Ensures product quality through the development and implementation of complete quality plans including CMM programming, gage design and procurement, and inspection plans., • Coordinates and/or performs validation activities (IQ, OQ, PQ) designed to qualify the equipment and the process as required., • Teams with the CNC Engineer to design work-holding devices and tooling as needed to ensure the desired outcome., • Investigates root cause of customer and/or supplier rejections and internal quality failures, dispositions non-conforming parts, recommends and implements effective corrective action as required, and provides accurate and timely responses to customers., • Determines the impact of ECNs on bills of material, routing, and spares, and coordinates any change., • Leads the post-production review and evaluation of the part-specific process, including equipment performance and product quality, recommends improvements, and coordinates their implementation., • Provides direction and on-the-job training to engineering and production associates regarding manufacturing methods and practices, as well as recommends, develops, and implements complete training programs, including materials and assessments., • Champions lean manufacturing principles by encouraging lean thinking in all aspects of development and production, as well as conducting and/or coordinating training and implementation with managers and associates., • Understands and complies with company policies, safety guidelines, quality system procedures, and housekeeping standards.Additional Duties and Responsibilities:, • Program, troubleshoot, and manage the Universal Robots arms., • Oversee the fixture designs, programs, prove outs, operation, and maintenance of the automated blasters., • Identify opportunities for automation within the organization and develop solutions to enhance productivity., • Collaborate with various departments to implement automation projects., • Ensure all automated systems comply with safety and quality standards., • Provide training and support to staff on the use of automated equipment. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience Bachelor’s degree from a four-year college or Manufacturing Engineer Certification and 8-10 years related experience and/or training; or equivalent combination of education and experience. Required Skills, Knowledge, and Abilities: • Ability to read, write, and speak English. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, customers, and the general public., • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations., • Experience with computer applications, including word-processing, spreadsheets, graphs, databases, CAD, and presentations., • Experience with process capability, Gage R&R, and statistical techniques., • Experience in using basic and advanced measuring tools and equipment., • Applied knowledge of Geometric Dimensioning & Tolerancing (GD&T)., • Capable of working independently as well as collaborating and coordinating efforts with colleagues., • Ability to establish priorities and manage multiple activities and requirements in a changing, fast-paced environment., • Experience with manufacturing materials, manufacturing processes, and secondary processes., • Project management skills.Desired Skills, Knowledge, and Abilities:, • Advanced metrology (CMM programming, vision system, etc.)., • Lean/Six Sigma. Triangle is proud to be an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Powered by JazzHR QvoSIKq1TI

Job Description Department: Quality Location: PTI Tech, Clifton NJ Reports To: Director of Quality Mission To uphold and advance the highest standards of quality across all stages of manufacturing—ensuring compliance with AS9100 and customer-specific requirements through robust documentation, risk management, and process validation. This role exists to proactively prevent quality issues, support internal and customer-facing investigations, and strengthen PTI’s reputation as a trusted partner for mission-critical components. Competencies – What This Person Must Be Standards-Driven: Understands and applies AS9100, ISO 9001, MIL-STD-1916 and customer-specific standards; ensures audits, validations, and ongoing operations meet all requirements. Root Cause Problem Solver: Leads investigations using 8D, 5 Whys, and Ishikawa methods to ensure sustainable corrective actions. Process Control Advocate: Uses SPC, PFMEA, control plans, and capability studies to ensure consistent, capable production. Metrics-Driven: Uses data analysis to monitor trends, reduce scrap, and eliminate recurrence of quality issues. Customer-Focused: Communicates clearly with aerospace, defense, and other high-stakes clients; drives issues to closure and delivers timely updates. Cross-Functional Collaborator: Partners with Engineering, Manufacturing, and Production teams to align on requirements, validate processes, and resolve issues quickly. Detail-Oriented: Manages documentation and compliance requirements with accuracy including FAIRs, PPAPs, CAPA records, SOPs, and quality alerts with full traceability. Self-Directed and Proactive: Takes initiative to identify and resolve quality risks without being prompted and with minimal supervision; follows through on actions with rigor and accountability. Key Responsibilities • Drive quality improvements through Gage R&R studies, Statistical Process Control (SPC), Six Sigma, and Lean Manufacturing tools., • Lead investigations into internal and external quality issues; document findings and ensure timely resolution., • Perform root cause analysis using structured problem-solving methods (8D, 5 Whys) and verify the effectiveness of corrective and preventive actions (CAPA)., • Coordinate timely responses to Supplier Corrective Action Requests (SCAR), Non-Conformance Reports (NCR), customer complaints, and quality-related queries., • Prepare and maintain First Article Inspection Reports (AS9102), Production Part Approval Process (PPAP-AS9145) documentation, and validation (IQ/OQ/PQ)., • Lead risk assessments (PFMEA) and develop control plans to mitigate quality risks., • Track and analyze defects and scrap data to identify trends and prioritize corrective actions., • Collaborate with manufacturing and engineering to improve processes and define inspection criteria., • Own inspection processes, including CMM (Zeiss – Calypso), OGP, and Keyence programming, as well as inspection fixture design (SolidWorks preferred)., • Oversee QC personnel training in partnership with manufacturing engineering to establish visual standards and develop work instructions., • Maintain SOPs, work instructions, inspection procedures, and training logs in compliance with AS9100., • ≥ 98% Quality Shipments, • ≥ 90% Gage R&R Pass Rate, • ≥ 1.33 Cpk for Stable Processes, • ≤ 3% Internal Scrap Rate on assigned processes, • ≥ 95% CAPA Effectiveness, • ≥ 95% On-Time Submission of FAIRs, PPAPs, SCAR’s, and CAPA’s, • Bachelor’s degree in Mechanical, Manufacturing, or a related Engineering field, • 3–5+ years of quality engineering experience in injection molding or precision manufacturing, • Working knowledge of AS9100, ISO 9001, and MIL-STD-1916, • Experience with FAIR, PPAP, SPC, PFMEA, control plans, and CAD (SolidWorks preferred), • Proficiency in statistical tools (Minitab, JMP, Excel) and QMS/ERP systems, • ASQ Certified Quality Engineer (CQE) or Six Sigma certification, • Experience in the defense, aerospace, or medical device industries, • Hands-on inspection experience, including CMM, optical, or non-contact methods, • Ability to stand and walk on the production floor for extended periods, • Capable of lifting up to 40 lbs and accessing production and inspection equipment, • Manual dexterity for handling tools, parts, and inspection equipment, • Visual acuity sufficient to read prints, inspect parts, and identify quality defects, • Manufacturing facility with exposure to injection molding machines, CNC equipment, and secondary operations, • Requires use of PPE, including safety glasses, gloves, and hearing protection, • Frequent collaboration with production, maintenance, and engineering teams on the floorCompany DescriptionEngineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it. PTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.Engineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it.\r\n\r\nPTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.

Job DescriptionQuality Control Microbiology SupervisorAllendale, NJ The Quality Control Microbiology Supervisor organizes, and directs staff to meet and exceed cGMP requirements, establish KPI’s, while adhering to quality control-microbiological and technical standards. Provides oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Team Leadership - Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervised the following roles: QC Microbiology Associates, • Investigate and document non-confirming events and environmental excursions., • Troubleshoot and recommend process improvements to achieve greater efficiency ad meet quality goals., • Interact with other Microbiology departments on a regularly scheduled basis to discuss and harmonize best practices, procedures and processes between the sites., • Participate in department and cross functional meetings., • Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Author and revise Standard Operating Procedures, Work Instructions, forms and Protocols to reflect current practices., • Perform microbiological and environmental monitoring data review. Compile and issue quarterly and annual Environmental Monitoring trending reports., • Provide staff development through feedback aimed towards performance development and review., • Ability to remain focused and effective in high stress situations., • Builds constructive working relationships characterized by a high level of acceptance, cooperation, and mutual respect., • Able to handle challenging interpersonal relationships., • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Aseptic Processing StandardsREQUIREMENTS, • BS in Microbiology or relevant field required., • Biotechnology Certificate and/or cGMP experience, • Minimum of 3 years of experience with environmental monitoring or within the biopharmaceutical industry., • Strong knowledge of microbiological test methods, philosophies, method validation and method transfer., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office, Excel, and MODA., • Must have ability to work in a team-oriented environment and with vendors., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The employee must be able to comply with personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role., • An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects., • Must be physically capable to stand, walk, sit, bend, stretch, use hands to handle or feel, reach with hands and arms, and talk or hear., • The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance), • Heavy cryo-gloves must be used when working with liquid nitrogen, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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

Job 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 DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-O-Vator available for use., • Small breakroom available. No on-site cafeteria available.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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

Job DescriptionQuality Control Analytical ScientistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a Senior Member of the team the QC Analytical Scientist will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle. • Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients., • Support routine GMP testing as assigned. Mentor and train team members, • Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements., • Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports., • Create validation project plan i.e., timelines and resources and provides status updates to management. Utilize statistical tools for evaluation of method validation and trending data., • Identify, evaluate, and implement continuous business process improvements., • Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS)., • Provide support during laboratory investigations., • Train QC personnel during method transfer and validation. Provide support during equipment qualification., • Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices., • Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures., • Indirectly may supervise cross functional teams including product development, QA, PMP, and Manufacturing.REQUIREMENT, • B.S Analytical Chemistry or other scientific field or MS/Ph.D. in Analytical Chemistry or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products., • 8-10 years of experience in the areas of method development, validation, and transfer., • Direct GMP Experience., • Proficiency in project management skills and tools., • Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc., • Extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs., • Strong Quality orientation with attention to detail required. Analytical and problem-solving skills required., • Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution., • Excellent presentation skills. Ability to communicate to upper management, across departments and within the immediate QC team., • Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction., • Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external., • Must be familiar with GMP lab environment and Aseptic techniques.Working EnvironmentMust have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays, or overtime and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facilityMay work with hazardous materials and chemicals Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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

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

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

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

Job Description Job Title: Project Engineer Company: PTI Tech Location: Clifton, NJ (On-site) Industry: Manufacturing / Metal & Plastic Injection Molding Experience Level: Mid to Senior Level About PTI Tech PTI Tech is a leading provider of advanced manufacturing solutions, specializing in precision metal and plastic injection molding for the aerospace, medical device, industrial, and defense industries. We are growing our technical team and seeking a skilled and motivated Project Engineer to support innovative product and process development efforts. Position Summary PTI Tech has an immediate opening for a Project Engineer to support the design and development of new products, components, and advanced manufacturing processes. This position plays a key role in PTI’s R&D and production programs, working closely with the Engineering Manager and cross-functional teams. Responsibilities include initial concept design, 3D modeling, analysis, prototyping, process development, vendor coordination, and supporting the implementation of novel engineering solutions. The ideal candidate is passionate about mechanical design, manufacturing innovation, and automation. We’re looking for a hands-on engineer with strong problem-solving skills, project leadership experience, and the ability to work effectively in a fast-paced, team-oriented environment. Key Responsibilities Design & Development • Develop production processes, tooling, fixtures, and manufacturing cells with a focus on quality and repeatability., • Perform technical and requirements analysis, researching new materials, technologies, and processes., • Apply DFM to assess part moldability and recommend design improvements for injection molding (plastic, metal, ceramic)., • Lead engineering projects from concept through production, coordinating cross-functional teams and external partners., • Create and manage project timelines, task assignments, and deliverables., • Write detailed work instructions, set up manufacturing equipment, and establish standard operating procedures (SOPs)., • Design and implement automation processes to increase manufacturing efficiency and consistency., • Program and troubleshoot Universal Robots and Arburg robotic systems., • Design and develop custom end-of-arm tooling for robotic automation., • Integrate automation systems into production workflows and support new product introductions (NPIs)., • Support ongoing production by resolving technical issues and improving part quality., • BS or MS in Mechanical Engineering, Materials Science, or related field., • Proficiency in CAD design using SolidWorks., • 5+ years of experience in mechanical design and development of injection-molded or over-molded parts and assemblies., • Strong knowledge of DFM, injection molding (plastic/metal), tool and mold design, and automation integration., • Experience with machine shop processes: turning, milling, EDM, and CNC machining., • Fluent in interpreting engineering drawings and applying GD&T., • Strong project management and organizational skills., • Experience in aerospace, medical device, defense, or industrial sectors., • Familiarity with additive manufacturing., • Experience with process validation, lean manufacturing, and quality systems., • Program management experience is a plus. Company DescriptionEngineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it. PTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.Engineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it.\r\n\r\nPTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.

Job DescriptionValidation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device IT & Human Resources disciplines in New Jersey. The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing and QC lab equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. • Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc., • Execute IQ/OQ and /or PQ protocols, • Prepare final reports for executed protocols, • Prepare final reports for vendor IQ, OQ and/or PQ protocols, • Review of executed IQ/OQ/PQ protocols and raw data, • Perform periodic review/requalification of validated equipment, systems and cleanrooms, • Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met, • Assembling validation related documents; and filing/archiving approved documents, • Maintaining electronic records.REQUIREMENTS, • BS/BA in engineering or a related Science discipline, • 3-7 + years of validation experience, • Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc., • Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11., • Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary., • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management., • Must be a dedicated self-starter with a high energy level and able to achieve results., • Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution., • Good time management skills to manage and meet deadlines., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment., • Good computer skills and Microsoft Office knowledge., • Ability to multi-task team is essential., • Flexible and able to adapt to company growth and evolving responsibilities., • Highly organized, detail oriented, and ability to manage multiple priorities., • Ability to perform the job under direct or indirect supervision, • Must have the ability to work in a team-oriented environment and with clients, • Must have the ability to work with specialized equipmentMay occasionally work with pressurized systems. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.Ability to work in cleanroom environment for a moderate amount of time.Ability to lift, transfer, or ship validation equipment or related accessories.While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, or crouch. Must where PPE when appropriate. This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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

Job Description One of the nation’s largest independent testing facilities seeks an Analytical Chemist with a minimum 2 years' experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Responsible for performing physical, chemical and instrumental techniques on APIs, raw materials and finished products according to schedule. Must have the technical ability to understand client requirements and assist in the preparation of testing protocols. • Run instrumentation such as, but not limited to: ICP-MS, HPLC, GC,UV, IR, AA, DSC, KF on products according to compendial, client and internal methodologies., • Prepare standards and samples for analysis., • Perform physical, chemical and instrumental techniques on APIs, raw materials and finished products., • Execute method transfer and validation protocols., • Document work clearly and accurately., • Perform technical writing and peer review as needed., • Operates and maintains laboratory equipment and instrumentation required for cGMP analysis of samples., • Bachelor's degree in chemistry or other related degree, preferred., • Minimum 2 years of product testing experience in a GMP laboratory., • ICP-MS/OES experience required., • Previous data acquisition software (Totalchrome, Empower, etc.) experience required., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Ability to stand/sit in office and laboratory environment., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Vision accuracy and color detection are required for this position, • Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc., • Ability to lift up to 30 lbs.Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

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

Job Description Summary: The Third-Party Vendor Manager is responsible for the daily oversight of vendors delivering services and technology solutions to the Bank. This role also manages the administration and optimization of the Bank’s vendor management software platform, ensuring effective vendor performance monitoring, compliance, and risk mitigation. Job Responsibilities: Vendor Risk Assessment & Oversight • Lead the risk assessment process for new vendor engagements, ensuring thorough documentation of all discrepancies, deficiencies, and identified risks., • Oversee the validation and classification of vendor questionnaires submitted by internal business units., • Manage periodic reviews of active vendors in alignment with tier-based monitoring protocols., • Support advanced cybersecurity reviews (including Zero Day Assessments) in partnership with the ETRM team., • Partner with senior leadership including the Lines of Business, Compliance, and other departments to escalate and resolve due diligence issues., • Prepare and present reports during Vendor Management Committee meetings to support strategic oversight., • Develop committee meeting agendas and materials in collaboration with executive stakeholders., • Develop monthly and quarterly risk reports for Senior Management, the Vendor Management Committee, and the Board Risk Committee., • Manage third-party risk analysts, ensuring effective task delegation, performance feedback, and continuous growth., • Serve as lead liaison for internal audits and regulatory examinations involving third-party risk., • Administer the Bank’s vendor management platform, including user support, vendor onboarding/termination, and access control reviews., • Bachelor's degree in a business-related field such as Finance, Accounting, Risk Management, or Information Systems., • Minimum of 5 years of experience in third-party risk and operational risk management, preferably within the financial services sector., • Strong working knowledge of the third-party risk management lifecycle, including due diligence, onboarding, and ongoing monitoring., • Proven expertise in third-party risk assessment methodologies and technologies, including familiarity with current cybersecurity and vendor oversight solutions., • Exceptional critical thinking and decision-making abilities, with a focus on proactive problem solving., • Demonstrated leadership skills, with experience supervising teams or leading complex projects., • High level of accuracy and attention to detail, with consistent adherence to tight deadlines., • Advanced proficiency in Microsoft Office Suite, including Excel, Word, and PowerPoint., • Excellent communication skills: verbal, written, and interpersonal—with the ability to engage stakeholders across all levels of the organization., • Capacity to manage multiple concurrent projects in a fast-paced environment, maintaining structure and accountability., • 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 DescriptionSr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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

Job Description Senior Health Economics Analyst Location: Remote Supervisor/Reporting to: Director, Performance Reliability Job Purpose: The Senior Health Economics Analyst is responsible for identifying and delivering data-driven insights and analytical support to senior leadership of IVIRMA North America. Success in the role will be achieved through the ability to leverage both qualitative and quantitative data to create business intelligence to guide strategic execution. This role serves to create and deliver reliable, insightful and actionable insight to improvements and opportunities for performance reliability – supporting our teammates in delivering a world-class patient experience. Essential Functions and Accountabilities: • Supports the design, development, and implementation of reporting to support data-driven decision making and insight. Partners with finance, commercial and business leaders to translate needs and requirements into dashboards and reporting with high utility., • Assists in the design and evaluation of organizational KPIs for potential replacement or evolution as the organization grows., • Prepares and analyzes medical cost and leading indicator data to develop presentations for executive and senior leadership. Interpret results and articulate actionable recommendations that maximize outcomes and ensures organizational targets are met., • Tracks performance of key performance indicators for outlined regions and teams as requested., • Supports finance, commercial and operations in the annual and multi-year planning processes including market durability, • Performs data validation to ensure completeness and accuracy of queries and reports and reconciles discrepancies., • Participates in the maintenance of existing queries and reports, re-writing and enhancing these queries as needed., • Participates in the presentation of complex concepts and results to end users and stakeholders Academic Training: • Bachelor’s degree in Computer Science, Information Services, or other technical or healthcare field – highly preferred, • Studies level: University Education (Bachelor’s Degree), • Studies area: Computer Science/Engineering or other related field Position Requirements/Experience: • Experience working in medical/healthcare industry - preferred, • Knowledge of data collection, storage, and maintenance concepts - required, • Knowledge in predictive modeling - a plus, • Database organization, design, and maintenance skills., • Ability to troubleshoot database programs Technical Skills: • Knowledge of PowerBI - required, • Knowledge of Microsoft Office Suite: Word, Excel (Pivot Tables/Look-Ups), Access, and OneNote – required, • Knowledge of Tableau - preferred IVI-RMA offers a comprehensive benefits package to all employees who work a minimum of 30 hours per week. • Medical, Dental, Vision Insurance Options, • Retirement 401K Plan, • Paid Time Off & Paid Holidays, • Company Paid: Life Insurance & Long-Term Disability & AD&D, • Flexible Spending Accounts, • Employee Assistance Program, • Tuition Reimbursement About IVIRMA Global: IVIRMA is the largest group in the world devoted exclusively to human Assisted Reproduction Technology. Along with the great privilege of providing fertility care to our patients, IVIRMA embraces the great responsibility of advancing the field of human reproduction. IVIRMA Innovation, as one of the pillars of IVIRMA Global, is a renowned leader in fertility research and science. Check out our websites at: & EEO “IVIRMA is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind: IVIRMA is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at IVIRMA are based on business needs, job requirements and individual qualifications, without regard to race, color, religion and/or belief, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. IVIRMA will not tolerate discrimination or harassment based on any of these characteristics. IVIRMA encourages applicants of all ages.”

Job DescriptionQuality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. • Develop and maintain training program within Quality Control which includes, onboarding and continuous training, • Manage deviations, CAPAs, change controls and document review to ensure compliance, • Ensure OOS investigations are completed adequately., • Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories, • Identify resources needed for training and compliance and build team accordingly, • Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements., • Monitor effectiveness of CAPAs, change control activities, and audit observation closure., • Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators, • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory experience in a cGMP environment a must, • 3-5 years’ experience in the pharmaceutical, biologics ore related industry, • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position, • Sound understanding of cGMPs, • Experience in laboratory training and compliance, • External laboratory management experience, • Strong knowledge of testing methodologies, philosophies, method validation and method transfers., • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Experience with laboratory training programs, • Knowledge of GMP requirements, • Excellent organizational and leadership skills, • Outstanding analytical problem-solving abilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Essential Job Functions Creates designs using industry standards, client guidelines, manufacturer specifications, and Squan standards. Uses value-based engineering approach to make design/routing/environment decisions to create an efficient, quality, constructable design. Creates design prints and construction prints/drawings always taking into account customer standards and requirements, and SQUAN processes. Creates splicing documentation that is accurate. Posts as-built plant records based on construction daily reports and/or redline drawings. Works closely with internal Project Managers, peer designers or drafters, design lead, and design manager to ensure quality and timely delivery. Drives profitability by creating constructable, quality designs that meet customer requirements, approval and SQUAN standards. Stays current with scope changes and understands the scope applicable to the work being performed. Communicates with permit coordinators/design leads and keeps project tracker(s) current up to the hour. Adheres to the timelines for design, drafting, drawing/print creation, quality control, and all other tasks. Collaborates with permit coordinator, design lead and design manager to overcome obstacles that prevent timely delivery of a quality product. Focuses on high level customer interaction to both internal and external customers. Validation of daily work received from the field to guarantee accuracy of both in-house and subcontractor deliverables where applicable. Attends meetings with design lead, design manager, or project manager as needed. May be required to draw various polygons in GIS tools as required by the project scope. Submits timesheets daily with the appropriate time coded to the project, aspect, and task. Performs other duties as assigned by Design Lead or Design Manager Skills and Abilities Ability to follow a process and interpret as-builts/redlines, internal QA redlines, standards, guidelines, and requirements effectively. Excels at organization, time-management, problem-solving, communication, and attention to detail. Employs a sense of urgency and has the ability to prioritize effectively. Good organizational skills with the ability to plan, coordinate, and track project development. Strong work ethic and leads by example and does what it takes to get the job done. Proficient in Microsoft Office Suite, ArcGIS, AutoCAD, and with various other software programs. Ability to always communicate professionally, with clarity, at the frequencies required by management and customers. Takes feedback well and has the ability to take said feedback and make sufficient adjustments. Work independently with minimal supervision. Minimum Requirements Must be 18 or older. Must be proficient in ArcGIS and AutoCAD with 5 years minimum experience. Able to work with minimal supervision and complete tasks assigned in a timely manner. Valid driver’s license and excellent driving record. Must be able to pass pre-employment drug test and background check. Preferred Requirements Bi-lingual (Spanish/English) Vetro, IQGeo and other system experience is a plus. Bachelor’s degree in engineering, business administration, or a related degree Two years of experience in telecommunication, OSP, or with a public or private utility.

* Senior Manufacturing Technician – Allendale, NJ Position Summary/ Objectives The Senior Manufacturing Technician will be responsible for the manufacturing of quality medical devices and research products that are safe and effective. This position will also maintain process controls and lead their own team of employees. The ideal candidate has a solid understanding of Science and the manufacturing process and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality. Essential Job Functions: • Manufactures products in accordance processing batch records using manual and semi-automated equipment, • Utilizes measuring instruments such as pH meters, temperature and humidity probes, • Maintains and calibrates equipment as needed., • Keep work area cleaned and well organized., • Inspect work area upon arrival and departure for proper safety and eGMP housekeeping., • Accurately completes batch records and associated documentation, • Troubleshoots equipment and process problems, • Prepares production schedules and maintains product inventories, • Supports process development, validation and design transfer activities, • Performs process trending and data analysis and prepares technical reports and investigations, • Capable of supervising a small team of manufacturing technicians, • Verify processing data and conduct processing checks, • Initiate, recommend and provide solutions through designated channels. Education, Experience and Certification: • Bachelor’s degree in a science related field, • Detail oriented and self-motivated, • Solid written, verbal communication and collaborative skills, • Efficient, organized and strong ability to work independently, • Ability to adhere to SOPs, • Previous medical device, pharmaceutical or clean room experience is a plus, but not required

Senior DeltaV Control Systems Engineer Lead Complex Life Sciences Automation Projects Control Associates is seeking an experienced Senior DeltaV Control Systems Engineer to join our elite engineering team. In this role, you'll serve as a technical leader on large-scale control system implementations for premier pharmaceutical and life sciences clients, taking projects from initial proposal through successful commissioning while mentoring the next generation of control systems engineers. About This Opportunity: This is more than just an engineering role - you'll be a trusted technical advisor to our most important clients in the pharmaceutical and life sciences industries. Working with cutting-edge DeltaV control systems, you'll design solutions that ensure the safe, efficient production of life-saving medications and treatments. Your expertise will directly impact critical manufacturing processes that serve patients worldwide. Your Leadership Impact: • Serve as Project Technical Lead Engineer or Project Engineer for complex DeltaV implementations, • Lead control system project implementation from proposal through startup and commissioning, • Proactively mentor and develop team members, fostering their technical growth and career advancement, • Develop sophisticated control strategies for pharmaceutical and life sciences applications, • Design and configure DeltaV graphics and control system databases, • Review and approve critical project design drawings, • Ensure comprehensive factory acceptance testing meets stringent industry standards, • Collaborate with Project Managers on planning, scheduling, and documentation, • Maintain cutting-edge expertise through continuous DeltaV and control systems training What You'll Bring: • Bachelor of science degree required, majors preferred include chemical engineering, biomedical engineering, electrical engineering, or computer engineering,, • 4+ years of industry experience in Pharma/Life Sciences environments, • Extensive DeltaV configuration experience with continuous or batch process control systems, • Experience with PLCs in batch or life sciences applications, • Knowledge of industry standards: ISA S88, GAMP5, and 21CFR11, • Ability to read and interpret P&IDs and instrumentation/controls wiring diagrams, • Experience with validation documentation (URS, GDS, DDS, FRS), • Site startup and process equipment support experience, • Database knowledge (SQL, Historians, querying), • Understanding of factory floor communication protocols, • Strong troubleshooting skills for process and process equipment, • Excellent communication skills for client-facing interactions How This Role Embodies Our Values: Customer Focus: You'll prioritize client needs by delivering exceptional technical solutions and maintaining strong relationships with pharmaceutical customers throughout the NYC Tri-State region. Collaboration: Working in a robust team environment, you'll achieve superior results by leveraging collective expertise and supporting multiple simultaneous projects. Innovation: You'll encourage thoughtful, creative solutions by developing cutting-edge control strategies and mentoring team members to think beyond conventional approaches. Integrity: You'll build trust through responsible technical decisions and honest client relationships, ensuring all work meets the highest pharmaceutical industry standards. Passion: You'll cultivate enthusiasm and dedication by continuously advancing your expertise and inspiring excellence in those you mentor. Professional Growth Opportunities: • Lead high-visibility projects for premier pharmaceutical clients, • Mentor and develop emerging engineering talent, • Continuous learning through company-provided DeltaV and control systems training, • Exposure to the latest pharmaceutical manufacturing technologies and industry standards, • Client site visits throughout the NYC Tri-State region Ready to Lead the Future of Life Sciences Automation? If you're an experienced control systems professional who wants to make a meaningful impact in pharmaceutical manufacturing while developing the next generation of engineers, this is your opportunity to join a team that values technical excellence, collaboration, and continuous innovation. Note: This position requires relocation to the NYC tri-state area if not currently local. Work visa sponsorship is not available. This is a direct hire fulltime position. Control Associates is an equal opportunity employer committed to diversity in the workplace. Control Associates is an equal opportunity employer committed to diversity in the workplace. Control Associates, Inc., offers competitive salaries that include a bonus potential. Base Salary range for this role is $90,000 - $120,000 Excellent benefits, including multiple medical plan choices, vision, and dental insurance with coverage for both employees and dependent family members. Medical and dependent care flexible spending benefits, health savings accounts, commuter tax benefit, company paid long-term disability and life/ADD insurance plans with a buy up option. Paid time off including vacation days, holidays, and sick days Our retirement plans include a 401(k) plan (with company match) and an Employee Stock Ownership Plan (ESOP), is a company-funded benefit that provides additional retirement compensation to qualifying employees. Certification/Training, we provide both in-house and Client/System specific technical training Control Associates Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, creed, race religion, color, national origin, citizenship, disability, sex, marital status, sexual orientation, familial status, gender, ancestry, or liability for services in the U.S. Armed Forces, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment. Control Associates participates in E-Verify. Click here to view About Control Associates Where Innovation Meets Industrial Excellence For over 90 years, Control Associates has been at the forefront of industrial process automation, transforming how critical industries operate across the New York tri-state area. What started in 1933 has evolved into a premier provider of cutting-edge process automation systems, software solutions, valves, actuation, pressure management, measurement technologies, and asset reliability services. Industry Expertise We're the trusted partner providing solutions and services in the Life Sciences, Natural Gas Distribution & Transmission, HVAC, Power Generation, Chemical Processing, and Downstream Hydrocarbons Industries. When precision matters, industry leaders turn to Control Associates. Global Partnership, Local Expertise Through our strategic partnership with Emerson, a global leader in process automation, we combine world-class technology with deep local market knowledge. This unique combination allows us to deliver solutions that are both innovative and tailored to our customers' specific needs. Our Culture of Excellence At Control Associates, we're driven by our core values: Customer Focus, Collaboration, Innovation, Integrity, and Passion. These values guide every decision we make and solution we deliver. We believe in building trust through responsible actions and honest relationships, while constantly pushing the boundaries of what's possible in industrial automation. Join Our Legacy of Innovation Based in Allendale, NJ, we're a team of problem-solvers, innovators, and industry experts who take pride in setting new standards for industrial process automation

QC Manager – Fairfield, NJ Summary: The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. This position will manage the staff to schedule and perform all necessary testing to support manufacturing and release requirements. Responsible for training and personnel development. This is a hands- on position. In addition to managerial responsibilities, this position will be performing analytical testing including wet chemistry, GC, HPLC, etc. as needed Responsibilities: • Lead, coach and manage a team of analysts to ensure data integrity and performance to meet business objectives, • Train and develop analysts, • Formulate, document, and maintain quality control standards and on-going quality control objectives, • Schedule workload to meet release objectives and deadlines, • Review, interpret, analyze and report HPLC/GC/UV/FTIR data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines, • Author analytical methods and SOPs, • Clean, maintain, and troubleshoot HPLC/GC/UV/FTIR instruments, • Develop specifications and analytical methods as required, • Develop analytical methods to support product development projects, • Prepare analytical method validation protocols and reports, • Perform Laboratory Investigations, root cause analysis, CAPA, Change Controls, Validations, Stability Programs, APRs, statistical analysis, environmental monitoring of air, water, and surfaces, as needed., • Manage the outsourcing process of testing to contract laboratories, • Ensure lab safety and manage chemical inventory, • Improve the compliance of the laboratory operations as well improve the efficiency and reduce the cost of the operations, • Perform duties of QC Analyst as needed including HPLC sample preparation and testing and any other testing requirements, • Audit the work of QC Analysts, • Other duties assigned by Management Education: • Bachelor’s degree in a scientific discipline (Chemistry preferred) with a minimum of 5 years’ experience in laboratory management OR Master’s degree in a scientific discipline (Chemistry preferred) with a minimum of 3 years’ experience in laboratory management Experience Requirements: • Experience with Empower 3, • Experience working in an FDA regulated environment, • Experience with GC sample preparation and testing, • Knowledge of USP Monograph testing, analytical method development & validation, • Knowledge of CFR & ICH Regulatory Guidelines, • Knowledge of cGMP processes, lab safety and GDP. Computer Skills: • Proficiency in Microsoft Word, • Proficiency in Microsoft excel, • Proficiency in Empower 3 Other requirements: • Has significant technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory., • Able to perform complex mathematical problems, • In depth knowledge of all laboratory equipment, practices, and procedures, • Demonstrated managerial abilities, • Problem analysis, solving and resolution skills, • Has excellent oral and written skills, • Has excellent interpersonal skills, • Is self motivated, • Has a very high attention to detail, • Has a positive attitude, • Must speak, read, and write in English, • Able to lift 25 pounds, • Able to stand for extended periods Hours: • Standard: 8:30 AM to 5:00 PM, Monday through Friday, • Occasionally: Extended hours and/or Saturday and Sunday may be required as necessary to support manufacturing.

Our client, who is in rapid growth mode located in Northern NJ, that is in the Retail, Commercialized Industry is currently seeking a Financial Analyst. • CANDIDATES MUST CURRENTLY LIVE AND WORK IN NEW JERSEY THAT DO APPLY!!! The Financial Analyst MUST have experience already having been involved in a full budgeting and forecasting cycle with a company. The hiring manager also wants the candidate to have dealt with large data sets of information, data visualization and is super strong with MS Excel. In addition, the Financial Analyst must have excellent communication skills, be detail-oriented, analytical, supporting strategic initiatives and providing key insights to drive business decisions. The candidate must have strong financial modeling expertise, advanced technical skills, and a proven ability to transform data into compelling narratives. Key Responsibilities • Assist with the preparation of budgets and forecasts, including detailed variance analysis., • Consolidate and distill summary budgets into site-level, brand-level, and account-level data, applying advanced allocation methodologies such as seasonality curves and week-over-week growth trends., • Develop complex financial models to support commercial, operational, and facility projects., • Create impactful presentations with data-driven visuals to effectively communicate insights and elevate storytelling., • Leverage advanced technical expertise in Excel for data analysis and reporting., • Utilize Power BI for synthesizing and optimizing large datasets for enhanced decision-making., • Analyze financial data to identify key business performance drivers using Smartview and EPM tools., • Prepare monthly financial reporting presentations for leadership, including insightful commentary and variance analysis., • Provide detailed expense reports and variance analysis for Head Office teams, supporting leadership with actionable insights., • Collaborate with Finance Business Managers and the Head of Transformation to analyze direct site costs, highlight outliers, and identify savings opportunities., • Oversee statistical account loads into ERP systems (PDI/EPM) and labor platforms (UKG), ensuring data integrity and validation., • Develop financial models for capital project assessments, presenting findings to the Investment Committee, analyzing returns (ROCE, Payback), and conducting post-project evaluations., • Support initiatives that drive business improvement and provide analytical input for ad hoc projects. Qualifications & Skills • Bachelor’s degree in Finance, Accounting, Business, or a related field; MBA preferred., • 2-3 years of experience in FP&A or a similar financial analysis role., • Industry experience in retail, wholesale, or quick-service restaurants is a plus., • Advanced expertise in creating complex financial models., • Strong analytical acumen with the ability to interpret and challenge data and probe financial systems effectively., • Proficiency in advanced Excel functions (Pivot Tables, Statistical Functions, etc.) as well as expertise in Power BI, Smartview, and Oracle EPM., • Exceptional presentation skills with the ability to create professional and visually compelling PowerPoint reports., • Adept problem-solving skills with a strategic and detail-oriented mindset.

Skill: Medical Device Design Controls, Design Verification & Validation Experience: 8~9 years Education: B.Adept with Design Control process for Medical Devices.Led Change Qualification projects for Medical devices, working with multi-cultured CFT.Strong Communication (written & verbal) and Leadersh

Responsibilities: Lead projects in compliance with Design Control processes for medical devices.Manage Change Qualification projects, collaborating with multi-cultural cross-functional teams.Oversee Design Verification, Validation, and Design Outputs in line with regulatory requirements.Drive all as

Overview Join our team as a variable shift, PRN, Psych Therapy Services Registered Nurse in Montclair, NJ. Why Join Us? Thrive in a People-First Environment and Make Healthcare Better • Thrive: We empower our team with career growth opportunities, tuition assistance, and resources that support your wellness, education, and financial well-being., • People-First: We prioritize your well-being with paid time off, comprehensive health benefits, and a supportive, inclusive culture where you are valued and cared for., • Make Healthcare Better: We use advanced technology to support our team and enhance patient care. The Registered Nurse— Inpatient Behavioral Health, will direct and oversee the care provided by other caregivers through delegation, validation, evaluation, and coordination. Qualifications Job Requirements: * Graduate from an accredited program of professional nursing is required. * Current and valid NJ Registered Nurse license * BLS certification required * Strong interpersonal skills * Customer/patient-centric attitude is a must Preferred Job Requirements: * Bachelor's of Nursing Degree preferred * A minimum of 1 year of experience as a registered nurse in a psychiatric or behavioral health care facility is preferred Rate of pay is determined based on experience and education, and may include other pay components such as differentials and call pay based on role.

Job Description Job Summary: The EVP, Scientific Affairs oversees the operations of the Quality Assurance and Quality Control Departments for all divisions across multiple locations and has overall responsibility for the technical operations and the strategic planning of adequate resources needed to ensure the required quality of laboratory operations meet business requirements and customer deliverables. They will develop, implement, and periodically evaluate the QC/QA Department activities to ensure the organization’s production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization to meet the requirements of customers, consumers, and regulatory and accrediting agencies. The role is also responsible for ensuring cGMP compliance across all business divisions within the Company. The EVP, Scientific Affairs will be accountable for the timely release of products at all steps of the Manufacturing process, based on justifiable rationale, valid scientific data, process control items, etc. Principle Responsibilities: • Directs all Scientific Affairs and assumes responsibility for all Quality related matters; sets priorities and oversees the daily efforts of the QC/QA Team., • Provides guidance and works with various Departments in maintaining cGMP compliance within all business divisions of the Company., • Initiates Quality processes that drive continual improvement within the organization., • Conducts internal quality control audits and random inspections of each site’s Quality Management System as required and periodically reports on status of quality control and operations to executive leadership and, when required, regulatory agencies., • Provides support for third party cGMP certification audits and ensures appropriate corrective actions are conducted., • Directly involved with on-site regulatory (FDA, NJ-DHHS, etc.) inspections as well as internal and third-party audits and writing and overseeing responses to audits to comply with cGMP and GLP. Serves as the contact person and co-hosts any regulatory agency audits and inspections and provides guidance in responding to any regulatory agency questions or observations., • Facilitates communication among production divisions and management. Provides support to Manufacturing and Product Development as required to troubleshoot production problems and collaborates with management and senior staff across production departments and roles to draft acceptable quality standards., • Evaluates internal and external laboratory capabilities. Recommends new testing procedures and equipment to support cGMP and customer specific requirements., • Develops and implement standards, methods, and procedures for inspection and testing, validation of systems and analytical processes, documentation, and change control systems that ensure the identity, purity, strength, and composition of ingredients and finished products are to specifications., • Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements and monitor the compliance through robust internal audit program., • Ensures all laboratory controls and functions and all Quality Control functions as designated in 21 CFR GMP Part 110, 111 and 117 are in place, documented, monitored and enforced to maintain the QC Lab within a cGLP environment at all times., • Assess test results and approve recommended changes., • Review quality control documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance., • Select, upkeep, calibrate, recertify, and document all instrumentation in the QC lab., • Oversee lot release of components, raw materials, and finished products., • Develop raw material specifications and finished product specifications once material has been through the Product Development process and route for signature., • Ensure sampling and testing priorities are consistent with Manufacturing, Production, and Customer Service schedules., • Preparation of analytical documentation (OOS, deviation reports, test methods, change controls, Certificate of Analysis) for incoming raw materials and finished goods., • Review technical control documentation (SOPs, Batch Records, test methods, specifications, COAs, etc.) from a Quality and Compliance perspective; ensure continuous improvement of departmental SOPs to stay up to date with regulatory and compliance guidelines; create, revise, and gain approval to implement lab SOPs and procedures and to review qualification documents for laboratory instrument/software as is necessary., • Maintain and improve department performance to meet requirements of Regulatory Authorities as well as the policies and standard procedures of the company., • Ensure that all systems, laboratory controls, procedures and instructions are described adequately to enable assurance of quality of the test results generated in the QC laboratories., • Provide technical guidance for validation of analytical methods and develop overall strategy to manage all critical reagents, reference standard, and reference control materials used in the laboratory., • Establish proper communication channels to manage, mentor direct reports to higher levels of management capability and provide strategic leadership to further strengthen the platform with a highly functional QC team., • Plan strategically/proactively with management of other platforms to ensure that resources are allocated adequately to meet each program’s needs., • Ensure that QC decisions are aligned with governance from Company Procedures and regulatory requirements., • Coordinate management structure of the laboratory to build Analytical datasets (release, and analytical verification) for Starting materials, In Process and Finished goods., • Identify gaps and assist with annual budget at both CAPEX and Operation levels. Direct – AVP, VP or Director of QC, QC/QA Team Indirect – Production Staff Supervisory Responsibilities: • Directs and oversees the quality control and quality assurance departments and supervisory staff., • Train QC/QA Team as necessary and validate their work periodically., • Perform annual performance reviews that are timely and productive and develop training plans with direct reports., • Handle discipline and termination of employees in accordance with company policy., • Ensure staff are provided with corporate communications. To perform this job successfully, an individual must be able to perform each principal responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Education: BS degree in Chemistry, Engineering or Life Sciences required. Advanced degree preferred. Experience: 10 years in the manufacturing QC/QA field with a minimum of 5 years supervisory experience directing QC/QA and Documentation function within the Nutraceutical or Dietary Supplements industry is required. Solid overall knowledge of USP, FCC, and FDA guidelines as applied to testing of cosmetic and dietary supplement ingredients and finished goods. Experience leading FDA inspections is highly desirable. The desirable candidate will also be knowledgeable in analytical instrumentation (i.e., HPLC, GC, UV-Vis, FT-IR, Atomic Absorption, TLC and USP dissolution apparatus 1 and 2). Working knowledge of product stability studies and microbiological analysis of raw materials, in-process and finished goods required. Physical Requirements: Work requires ability to lift up to 25 pounds; sitting, standing, walking, bending and/or stooping for periods of five hours or more; moving and examining objects at high and low reach, and reading for periods of three hours or more; prolonged periods working on a computer. Position requires normal visual acuity. Additional Skills and Qualifications: Proven experience managing technical services and staff. Demonstrated knowledge of current cGMP requirements, regulations and standards to ensure the maintenance of the cGMP standard of quality. Thorough understanding of quality control standards and methodologies. Thorough understanding of manufacturing and production in the industry. Ability to read and interpret documents such as safety rules, operating and maintenance work instructions, procedure manuals and SDS sheets. Must have the ability to communicate effectively orally and in written form. Must be able to add, subtract, multiply and divide in all units of measure using whole numbers, common fractions and decimals. Must understand and use advanced statistical methods. Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Must have ability to solve complex problems involving multiple variables in standardized situations. Must have a deliberate and acute sense of documentation of all activities while in the manufacturing environment. Must be proficient with and be able to communicate via e-mail. Must be proficient with and able to use computer software including word processors & spreadsheets (Microsoft Word, Excel, Access), and ERP System. Proficient in oral and written communication skills. Must be able to communicate effectively in a cross functional team environment to complete work tasks as instructed. Must have sound judgment and decision-making skills. Excellent organizational skills and demonstrated attention to detail and thoroughness are critical. Strong analytical and problem-solving skills. Strong supervisory and leadership skills. Vital Health America is an Equal Opportunity Employer Company DescriptionVital Health America is committed to manufacturing nutraceutical products of the best quality and features by adopting innovation in design and technology with the end target in mind. We can offer our clients a wide range of standard formulas to choose from or they can design their own unique supplement line. Our scale-up and industrialization experience means that the finished product is ready for large-scale production and commercialization, saving our clients both time and money.Vital Health America is committed to manufacturing nutraceutical products of the best quality and features by adopting innovation in design and technology with the end target in mind. We can offer our clients a wide range of standard formulas to choose from or they can design their own unique supplement line. Our scale-up and industrialization experience means that the finished product is ready for large-scale production and commercialization, saving our clients both time and money.

KEY RESPONSIBILITIES System Implementation & Support Assist in the validation, implementation, and configuration of MasterControl eQMS modules, including, but not limited to:. CANDIDATE REQUIREMENTS Minimum 5 years’ experience in MasterControl system administration in pharmaceutical/ CDMO,

Job Description POSITION:Seeking a marketing assistant to join the Marketing Department for our client’s New Jersey Office. This position will report to the Chief Marketing and Business Development Officer. RESPONSIBILITIES: • General support for the day-to-day marketing projects for the firm’s six offices, • Logistics coordination for Firm sponsorships (shipping materials prior to events, sending logos etc.), • Draft preparation/submission of charitable/program ads, update and maintain attorney’s bios Department descriptions and news scroll on website, • Preparing materials per instructions including pitch books, power points and event collateral Research and tracking for all charitable requests, • Posting of all blog entries in a timely manner, • Completion of all firm directory listings that require annual updates on new hires and departures,, • All marketing related assignments for community service projects,, • Competitive intelligence research as assigned,, • General inventory ordering/tracking for brochures, business cards, pitch book supplies,, • General administrative duties including invoice payment,, • Assist with special projects when requested including events and client gifting, data entry and validation into our experience database (Foundations), • Coordinate meetings, deploy firm communications using our email marketing platformREQUIREMENTS:, • College Degree., • Preferably a major/minor in marketing and/or communications, • Proficient in Microsoft Office Suite,, • Proficient in all social media outlets, including but not limited to, Twitter, LinkedIn, Facebook & Instagram

Job Description Overview JOIN THE FITNESS REVOLUTION! Are you looking for a fulfilling retail position that combines a love of helping customers find their Perfect Fit with great perks, a strong team environment, room to grow, and competitive earning potential? You're in luck, we are always looking for great talent to join our teams as; • Fit Experts- $21.50 hour (Base of $17.50 plus bonus of $4.00+ per hour), • Road Runner Sports is proud to have been recognized as the 2023 Footwear Retailer of the Year by Footwear Magazine., • Founded in a San Diego garage over 40 years ago., • Road Runner Sports has 52 stores across the country, and we are growing!, • You will join a family of Team Members who share your passion for a healthy and active lifestyle., • You will make a difference in customers’ lives as you help them on their journey to a healthier life!, • This is a sales-based position and you’ll be given the tools and training to make you successful., • You’ll be rewarded, through our generous bonus program, for your customer service and your ability to consistently hit your sales goals. Are you ready to RUN with us? Let’s see if you have what it takes Fit Expert • Reliability and flexible schedule availability (Will include a combination of days, evenings, holidays, and must be available on weekends), • Minimum of 1 year experience in customer service or sales. Seasoned salesperson (10+ years exp) preferred., • Positive attitude and willingness to work in a fun, lively, and energetic atmosphere every single day, • Ability to make your customers feel valued, • High School diploma or equivalent required. Associate’s degree from an accredited college or university and 1 year of related experience preferred, or equivalent combination of the education and experience, • Minimum of 1+ years of relevant leadership experience in a fast-paced specialty retail selling culture is preferred. Seasoned salesperson (10+ years exp) preferred., • Leadership skills including: Excellent customer experience behaviors, a strong sense of urgency, attention to detail, creative problem solving and sound decision making skills, effective delegation and validation and the ability to efficiently execute daily priorities, • Ability to work a flexible schedule, including nights and weekends depending upon the needs of the business, • Ability to perform the basic functions of the job., • Effective interpersonal communication skills in both verbal and written format., • Earn competitive pay plus bonus potential, • Receive out of this world training to grow your career, • Contribute to an OUTSTANDING team as you drive in store sales, • Be the envy of your friends with discounts on ALL the latest gear and footwear, • Enjoy free running and walking events, • Take pride in merchandising, and maintaining an immaculate workplace Qualifications After acceptance of a potential offer, the successful completion of a background check will be required prior to start date. The offer is contingent upon the information received in this report, and will be carried out in accordance with Local, State, and Federal laws. We’re committed to protecting your privacy rights. We collect personal information from you, including personally identifying information, professional or employment-related information, and educational information. The purpose of this collection is to assist in evaluating your application for employment. To ensure your application is received as timely as possible, we encourage you to apply directly onto our Road Runner Sports Career page. As you apply directly on our site, we will be reaching out to you within the next 10 days should your experience and qualifications meet our requirements for this position.

Job Title: Microbiology Lab Tech Location: Franklin Lakes, NJ Pay Rate: $39.69/hour Shift: 1st Shift Position Summary: We are seeking a detail-oriented and proactive Microbiology Laboratory Technician to join our team in the development and testing of pharmaceutical products, raw materials, and medical devices. This role will perform microbiological testing in a BioSafety Level-2 (BSL-2) laboratory under GLP conditions and support both routine and non-routine testing projects. Key Responsibilities: • Perform microbiological testing in accordance with USP, ASTM, ISO, and CLSI standards, including sterility testing, microbial limits, bioburden, and efficacy assays (time-kill, MIC/MBC)., • Plan and execute studies inside a BioSafety Cabinet, maintain microbiological cultures, and record viable counts of microorganisms (CFU)., • Support qualification, calibration, and validation of laboratory equipment and instruments., • Maintain laboratory notebooks and records in compliance with Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)., • Work independently with minimal supervision to complete assigned projects., • Coordinate or lead test requests as needed, under the direction of a supervisor., • Bachelor’s degree in Microbiology, Biological Sciences, Chemistry, or a related field., • Minimum of 1+ years of experience in a microbiology laboratory or related industrial experience (pharmaceuticals, medical devices, personal care, or cosmetics) in R&D or QC., • Experience in a BioSafety Level-2 (BSL-2) laboratory environment., • Strong attention to detail and organizational skills., • Experience in GxP-regulated laboratory environments., • Familiarity with Laboratory Information Management Systems (LIMS)., • Standing or sitting at a laboratory bench for extended periods., • Working in front of a biological safety cabinet for extended periods., • Ability to lift up to 25 lbs., • BioSafety Level-2 (BSL-2) laboratory., • Handling of biological, chemical, or human body fluids for testing. INDJP Job Type: Full-time

Job DescriptionDescription: Our company, Apotheco Pharmacy, is searching for a Floating Pharmacist. Regular travel will be required between our satellite locations in Bergen,NJ, Woodland Park,NJ, Parsippany, NJ, and Jersey City, NJ. Will be provinding coverage over the weekends 10 am -2 pm. Salary is based on upon experience. The Pharmacist will oversee and provide direction related to quality, clinical and compliance for Apotheco Pharmacy operations initiatives in compliance with state and federal laws. The Pharmacist will report to the Pharmacist-in-Charge. Must have excellent customer service skills and be detailed oriented. Work with Pharmacist-in-Charge to maintain and increase efficiency, quality, and customer service levels in the daily operation, as well as execute on department goals. Continue performing essential pharmacist functions of a staff pharmacist. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Duties and Responsibilities: They include the following; other duties may be assigned; 1. Manage staff of techs, patient care coordinators, and customer service representatives while on duty., 2. Adheres to all Apotheco policies., 3. Adheres to all applicable laws pertaining to the practice of pharmacy., 4. Maintains a safe and clean pharmacy by complying with procedures, rules, and regulations designated by the Board of Pharmacy., 5. Maintains records by recording and filing physicians' orders and prescriptions., 6. Responsible for all cash transactions and depositing of all transactions., 7. Ensures medication availability by delivering medications to patients and departments., 8. Contributes to team effort by accomplishing related results as needed., 9. Knowledge of medication and dosage measurements., 10. Proficient at pharmacy software system and electronic ordering of all medications., 11. Perform final check on prescriptions annotating on the prescription and scanning in changes, 12. Call physicians when applicable for refills, medication changes, and prior authorizations., 13. Making sure all drugs have a minimum of 6 months prior to expiration, 14. Perform return to stock duties for prescriptions not picked up within 14 days, 15. Counsel patients on all new prescriptions, 16. Pharmacist responsible for ensuring overall compliance with state and federal statutes., 17. Responsible for adherence in state environment, for all federal regulations involving prescription medication fulfillment for retail pharmacy., 18. Facilitate and monitor compliance with Prescription Drug Monitoring programs. 19. Oversee pharmacy team operations compliance (e.g. transferring prescriptions, handling inbound/outbound physician calls, efficient drug utilization management, safe dispensing, providing accurate and timely medication dispensing, & ensuring adherence and compliance with all state and federal regulations)., 19. Ensure quality and productivity standards are met and/or exceeded in a consistent basis., 20. Lead in communicating management of Pharmacy policy and procedures relevant to pharmacy compliance and quality standards; I. Facilitate implementation of new programs, enhancements. II. Maintain professional licensure, competence, knowledge and skills necessary to effectively complete responsibilities, enhance job knowledge and ability to actively pursue learning and self- development for you and your staff. III. Follows all policies and procedures relating to job responsibilities to meet corporate objectives. IV. CSOS ordering capability for site. Understanding how to order, file, and audit ordering C2 prescriptions electronically. V. Ensure Refrigeration logs are being filled out and monitored daily. Responsible for filing those logs electronically and in file cabinet. VI. PIC will be responsible for Alarm at site. PIC will have to be one of the people assigned on the alarm system or as assigned. VII. Recall of drugs responsible for returning drugs to wholesaler or direct vendor both legend and C2. Maintaining paperwork as required and contacting members when necessary. VIII. Expired drugs: responsible for determining procedures along with manager of fulfillment pertaining to disposal and credits of expired drugs. IX. Inventory: aid in the process of inventory validation as needed. X. Variances with inventory validate along with manager of inventory and finance any variances. XI. C2- all C2 prescriptions must be counted by a technician and then recounted by a pharmacist. C2 count one section per week or delegate to another pharmacist and record in controlled substance log. XII. Other activities as determined by management. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Language Ability: Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. Math Ability: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Computer Skills: To perform this job successfully, an individual should have knowledge of Microsoft products. Information Security Expectations: While performing the duties of this job, the employee is required to abide by Apotheco information security policies, employee handbook and security and privacy regulatory requirements. Each employee is responsible for the secure and appropriate handling of Apotheco information, information received by customers, other companies and/or external parties. Knowledge, Skills, and Other Abilities: • Strong drug product and clinical pharmacy knowledge, • Familiar with clinical program components, formulary designs, prescription benefit trends, and PA programs, • Time management skills, • Written and Oral communication skills, • Demonstrated ability to handle confidential information appropriately, • Ability to work independently with minimal supervision and self-motivated, • Strong computer skills, including MS Window, Word, Outlook, and Excel, • Excellent interpersonal and problem-solving skills, • Ability to work in a fast-paced call center environment, • Strong team building and leadership skills, • Strong customer service orientation and commitment to professionalism The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to walk; sit and use hands. The employee is occasionally required to stand. Benefits: Paid Time Off, Paid Holidays, Medical/Dental/Vision benefits, Short Term Disability, 401k, and Life Insurance. Schedule: • Licensed Pharmacist- NJ Required, • NY Preferred - Will be required to get licensed in NY within 3 months of employment.

Job DescriptionELLKAY started out providing connectivity solutions to laboratories and within a few years, grew to also provide data management solutions to ambulatory organizations. ELLKAY is now a trusted data management partner in five healthcare segments. ELLKAY’s solutions continue to serve laboratories and ambulatory practices and have expanded to empower hospitals and health systems, healthcare IT vendors, ambulatory practices, health plans, and other healthcare organizations with cutting-edge technologies and solutions that drive their growth and interoperability strategies. Today, ELLKAY remains true to our core values, building strong partner relationships and offering unparalleled service and support while providing innovative, scalable solutions to the challenges our customers face in today’s data-rich world. ELLKAY's experience, customer-focused approach, and reputation for innovation, speed, and accuracy differentiate ELLKAY as a premier partner for your interoperability needs and data management strategy. Job Description: This is a full-time, technically oriented-professional exempt position. A senior project manager in this position will be responsible for leading team(s) to deliver project(s) that span across multiple software solutions in the ELLKAY product suite to support our growing Health Care Delivery customer base. This includes management of issues, risks, and project change requests to ensure successful and on-time project delivery. The Sr. Project Manager – EMR Migrations has the authority to run each project on a day-to-day basis and is responsible for establishing and cultivating a positive working relationship with each customer from an Operations perspective. Essential Duties & Responsibilities: • Oversee the successful implementation of ELLKAY’s most complex EMR Migration and Data Archiving Solutions in the ELLKAY product suite., • Provide leadership for the project team by coaching, mentoring and motivating team members to meet project goals, adhering to their responsibilities and project milestones., • Work with customers to develop a comprehensive data migration strategy including goals, extraction plans and validation of migrated data., • Manage all aspects of multiple related projects to ensure overall success of the customer implementation., • Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation, and excellence., • Full project life cycle ownership: successful project delivery will include full implementation from initiation to deployment for one or more initiatives simultaneously., • Manage the day-to-day project activities and resources and chair the regular project status update meetings with the customer., • Create and follow prescribed policies, procedures, and processes for a successful implementation., • Demonstrate a functional acumen to support how solutions will address client goals., • Monitor, track, and control outcomes to resolve issues, conflicts, scope changes, dependencies, and critical path deliverables., • Understand interdependencies between technology, operations, and business needs., • Serve as primary point of contact for all project communication, both oral and written, • Set and manage appropriate expectations both internally and externally., • Collaborate and work with cross functional teams effectively, with a focus on organizational goals., • Participate and drive innovation towards process improvement., • Self-motivated, decisive, with the ability to adapt to change and competing demands., • Exceptional ability to communicate professionally with people at all levels of the organization and external contacts both verbally and in writing., • Demonstrated organization and planning abilities., • Strong skills with critical thinking, attention to detail, problem solving and decision-making capabilities., • Knowledge and experience in clinic or hospital-based applications and workflows., • Experience leading multiple large-scale and multifaceted projects., • Experience leading, motivating, and managing various project team sizes, including internal and external resources., • Demonstrated success in managing and delegating in a team-based environment., • Bachelor’s degree in appropriate field of study or equivalent work experience., • 5 years of related experience in the healthcare industry., • 5 + years of project management experience, including tracking and planning projects., • Intermediate level of proficiency with MS Project, Excel, Visio, and PowerPoint. ELLKAY offers a comprehensive and competitive benefit package that starts day one! Including: • A Competitive salary, • 401k w/ matching – once eligibility is met, • Work/life balance, • Paid Volunteer Program, • Flexible working hours, • Unlimited PTO, • Remote work options, • Employee Discounts, • Parental Leave, • Working with talented, collaborative, and friendly people who love what they do, • Professional growth within, • Innovation environment At ELLKAY, we are committed to operating as a hybrid workplace, offering employees flexibility in how they structure their time between in-office and remote work. We recognize the significance of fostering connections, collaboration, and creativity within our office culture and its positive impact on our business. Our philosophy of operating as a hybrid workplace underscores our dedication to enabling employees to tailor work-life balance to their individual preferences. For those who do not live within 40 miles of one of our offices, we are open to considering remote work for candidates whose skills and experience strongly align with the role. While we prioritize a hybrid work environment for most roles, we understand the importance of flexibility and are open to remote work for specific positions and specialized skill sets. For more information on our company, visit . ELLKAY LLC is a Smoke-Free Workplace. ELLKAY, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.