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Aquestive Therapeutics is hiring directly for several key positions, with Inizio Engage supporting the recruiting process. About Aquestive Therapeutics With more than 20 years of pioneering patient-centered innovation, we've transformed how millions access life-saving medications. Our track record speaks for itself: 6 FDA approvals, 2.5 billion doses delivered worldwide, and a presence across 6 continents. As we prepare to launch Anaphylm™, our latest breakthrough in overcoming patient barriers, we're building a sales team that shares our commitment to innovation that matters. The Role As a Therapeutic Specialty Representative (TSR), you’ll be on the front lines of a critical product launch, introducing Anaphylm to healthcare providers. Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis. If approved, people at risk for severe allergic reactions would have a device-free, needle-free epinephrine option. Similar in size to a postage stamp, Anaphylm is administered as a thin, dissolvable film placed under the tongue. As a Therapeutic Specialty Representative (TSR), you will educate healthcare providers on how Anaphylm is designed to address barriers that prevent patients from carrying and administering epinephrine, building trusted relationships to drive adoption of Anaphylm. This role is ideal for ambitious sales professionals who thrive in a launch environment and who want their work to have genuine clinical impact. Key Responsibilities Strategic Territory Development * Design and execute territory business plans that identify high-potential accounts and drive measurable market penetration * Analyze prescribing patterns, payer landscapes, and competitive dynamics to prioritize efforts and maximize ROI * Partner with Regional Sales Managers to align field execution with broader commercial strategy Clinical Education and Relationship Building * Deliver compelling, compliant clinical presentations that demonstrate Anaphylm's value in addressing unmet patient need * Build trust-based relationships with key prescribers, practice administrators, and healthcare stakeholders through consistent engagement and authentic dialogue * Navigate complex clinical objections with insight and empathy, positioning Anaphylm as the solution to real-world challenges Access and Pull-Through Excellence * Master payer coverage dynamics across your territory—national, regional, and local insurance landscapes * Collaborate with Market Access, to overcome prior authorization barriers and ensure seamless patient onboarding * Drive formulary wins and in-office pull-through by equipping providers with the tools and knowledge they need Flawless Execution * Orchestrate high-impact customer engagement programs including lunch-and-learns and speaker events * Maintain CRM excellence: capture detailed call notes, payer feedback, sampling activity, and strategic next steps with precision * Ensure 100% compliance with PDMA sampling requirements, AE/product complaint reporting, and promotional guidelines Field Intelligence * Serve as the eyes and ears of the organization, sharing customer insights, competitive intelligence, and best practices that inform strategy * Contribute to a culture of continuous learning and improvement across the sales organization Qualifications Required * Bachelor's degree * 3+ years of pharmaceutical, specialty, or B2B sales success with proven track record of exceeding targets * Deep understanding of payer coverage, prior authorization workflows, and access barrier navigation * Strong analytical skills with demonstrated ability to translate data into actionable territory strategies * Willingness to travel overnight 50% for customer meetings, conferences, and sales meetings Preferred * Launch experience in specialty or allergy markets. * Specialty pharmacy or hub services background * Experience selling products that address medication adherence or administration barriers Who Thrives Here * Mission-driven achievers motivated by outcomes results-oriented with passion for improving patient outcomes * Strategic hunters who combine creativity, persistence, and disciplined execution to drive market growth * Resilient and adaptable performers able to navigate obstacles, adapt quickly, and thrive in a competitive, fast-paced launch environment * Collaborative team players who elevate others while maintaining accountability for outcomes * Consultative and influential communicators who earn trust, educate customers, and drive conversion through insight and conveying value Compliance * Ensure field compliance with all company and industry standards, including: * Sampling and PDMA (if applicable) * Adverse Event (AE) and product complaint reporting * On-label and compliant promotional dialogue * CRM data quality and timely documentation * Maintain alignment with corporate policies, training, and legal/regulatory requirements. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected salary range: $125,000 - $150,000/per year. Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Aquestive provides equal employment opportunities to all colleagues 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.

Job DescriptionProvides administrative and secretarial support for the vice president and department. RESPONSIBILITIES • Monitors and oversees facility operations for a large biotech site., • Troubleshoots and performs repairs on system issues involving electronic, electrical, pneumatic, hydraulic, and mechanical devices, Johnson Controls Metasys BMS, utility, and water systems., • Supervisor in charge of facility housekeeping staff for second shift., • Generates work orders in SAP, participates in site emergency response and Hazmat activities. Novartis Pharmaceuticals 01 Sep 2005 - 01 May 2014 ENGINEERING TECHNICIAN 1216 5th Avenue New York NY , 10029 OK to contact this employer? - No RESPONSIBILITIES • Repaired, maintained, and calibrated pharmaceutical manufacturing, production and packaging equipment.

Job DescriptionPosition Description: Dr. Praegers was founded in 1994 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job DescriptionPosition Description: Dr. Praegers was founded in 1992 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job Description Unit Pack is a family-owned and operated company with over 50 years of experience in packaging liquids, creams, gels, serums, oils, and pastes in single-use packages catering to your packaging needs. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing your brand. At our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that your needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations. Job Summary: As a Machine Operator, you will be responsible for operating and maintaining the machines to ensure efficient production of high-quality goods. Your primary focus will be on inspecting packages, monitoring machine performance, and maintaining a clean and organized workstation. Attention to detail, physical strength, and technical skills are essential for this role. Requirements: ● The job requires the ability to lift up to thirty pounds without assistance. ● You should be able to stand for prolonged periods of time. ● Climbing tall equipment to replace parts is a frequent task, so it is essential to do so safely. ● You will be working in a loud production floor environment, and proper hearing protection is mandatory. ● You must have a keen eye for detail to continuously inspect and focus on small details of produced goods. ● Inspect 100% of packages during production, including checks on print quality, seams, welds, and fill volume. ● Maintain the correct position at all times while operating the machine. ● Keep the workstation clean and organized, properly arranging tool trays, scale tables, and roll tables. ● Keep the work station stocked with necessary supplies: alcohol, wipes, gloves… ● Assemble boxes and fill them with the correct number of packages while adhering to designated weight requirements. ● Replenish raw materials on printers and tube makers, while also disposing if waste properly ● Replace wear parts to maintain a high level of quality in production ● Line boxes with paper to check for leaks and perform leak tests on boxes containing paper. ● Clean the production line at required times following work instructions to prevent downtime, interruptions, and defective packages ● Identify and replace defective jaws on the machine. ● Empty the butt trim chip bucket and water collect bucket at the machine as needed. ● Perform visual inspection to ensure proper functioning of pumps and prevent air entrapment unless the order is complete. ● Clean pumps following standard operating procedures (SOPs) for pump cleaning at designated cleaning stations. ● Accurately complete all quality control paperwork, following instructions and performing necessary checks. ● Report any issues with paperwork to the quality control team promptly. ● Record all machine stoppages using the Down Time Log, communicating with mechanics to accurately document stations and actions performed. ● Complete all tasks outlined in the Machine Operators Work Instructions on a daily basis. ● Attend weekly Machine Operator meetings to stay updated on any changes or improvements. ● By diligently executing these responsibilities, you will contribute to the overall efficiency and productivity of the production process and ensure the delivery of high-quality goods to customers. *Please note that this job description is subject to change as needed based on the evolving requirements of the role and the production environment. Company DescriptionUnit Pack is a family-owned and operated company with over 60 years of experience in packaging liquids, creams, gels, serums, oils, and greases in single-use packages. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing brands. At our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that customer needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations.Unit Pack is a family-owned and operated company with over 60 years of experience in packaging liquids, creams, gels, serums, oils, and greases in single-use packages. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing brands.\r\n\r\nAt our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that customer needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations.

Job Description Join a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies. As a GCP Senior Auditor, you will play a key role in ensuring GXP compliance with global regulatory authorities, driving company-wide compliance initiatives, and strengthening quality management systems to minimize risk in a regulated environment. This role is ideal for a detail-oriented professional with strong Good Clinical Practice (GCP) experience and a passion for maintaining high-quality standards across global clinical operations. Key Responsibilities Audit Leadership & Compliance Oversight • Plan, conduct, and manage global clinical process and vendor audits across multiple trials., • Execute internal and external GXP audits, ensuring adherence to FDA, EMA, and ICH GCP guidelines., • Collaborate with clinical sourcing, supplier quality, and clinical partnerships to evaluate and manage CROs, CMOs, investigator sites, and other vendors., • Develop detailed audit reports and manage related non-conformance items., • Ensure alignment with corporate Quality Management Systems (QMS) and Standard Operating Procedures (SOPs)., • Support regulatory inspections by preparing documentation and participating in audit readiness activities., • Bachelor's degree in a scientific, healthcare, or related discipline., • Minimum 5+ years of experience in the pharmaceutical or biopharmaceutical industry., • Strong background in GCP auditing and safety/pharmacovigilance., • Demonstrated experience conducting and managing internal and external GXP audits., • Proven knowledge of FDA, EMA, and ICH GCP regulatory requirements., • Familiarity with QMS, SOPs, and compliance documentation., • Experience auditing CROs, CMOs, investigator sites, and clinical vendors., • Experience within a biopharmaceutical organization focused on neurology or psychiatry therapeutic areas., • Hybrid schedule: 3 days on-site (Tuesday-Thursday) in Paramus, NJ., • Flexibility is required as the on-site schedule may adjust over time., • Up to 10% travel may be required for audits and inspections.

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

Job Description SUMMARY: • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files, • Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications., • Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements., • Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data., • Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing. Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field. Experience: • Prior experience in pharmaceutical or regulatory writing., • CMC (Chemistry, Manufacturing, and Controls) Writer experience.

Job Description Auto-Chlor is now hiring an Electrical Engineer-Equipment Design to lead our engineering development initiatives. We’re looking for a leader who will contribute to our “People First” culture. This position would work in-office full-time at our facility in MEMPHIS, TN. What’s in it for you? • A people first culture where contributions and collaboration are encouraged and celebrated., • A competitive salary up to $150k annually with an excellent benefits package., • Ongoing wellness initiatives to improve your health and well-being. What are some of the day-to-day responsibilities? • Develops and implements solutions for dishwasher and dispensing innovation projects, including both new equipment development and existing equipment innovation. Projects vary in duration from two months to over a year based on Project Brief requirements., • Administers regulatory compliance with agencies such as NSF, CSA, UL, BOCA, ASSE, UPC, and Federal, State, and Local authorities. Provides support to the field sales team on regulatory issues, with an emphasis on maintaining customer equipment operation without disruption to business., • Provides technical support to field sales team, contractors, consultants, engineers, and architects., • Develops and manages technical documentation for design control and field use. Requirements: • Bachelor of Science in Engineering Degree or comparable years of work experience., • 5-10 years of electrical and electronic design experience, along with experience working with regulatory agencies. Experience in the commercial appliance industry is preferred., • Embedded Software/hardware design, • Knowledge of codes and standards for plumbing, sanitation, electrical, and building (NSF, CSA, UL, BOCA, ASSE, UPC, FDA), • Electrical/electronic circuit design, • CAD Modeling – Autodesk Inventor Preferred Location: 746 Poplar Ave Memphis, TN 38105 #PROFESSIONAL

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 Responsibilities include but are not limited to: Preparing and submitting customs entries: This involves preparing the necessary documentation and data to US Customs and Border Protection (CBP) and other government agencies like the FDA, Fish & Wildlife Service (FWS), USDA, etc. Transmission of Customs Entries to U.S. Customs for import shipments Ensuring compliance: Verify accuracy of documents (commercial invoices, etc.) and ensure compliance with US Customs regulations.. Coordinating with various parties: Communicate and coordinate with internal / external customers, carriers, freight forwarders, customs officials and other agencies to ensure smooth clearance of good Problem-solving: Resolve documentation discrepancies, Customs exams, FDA holds, or other issues related to Customs clearance. Receiving, reviewing, and processing import documentation for an assigned base of accounts Preparing daily activities including: preparing delivery orders and coordinating the pickup and delivery of cargo, filing ISF (Importer Security Filing), answering emails Processing documents through the system and interface and providing updates and communications for internal and external customers to produce timely and compliant transactions Tracing key transaction information such as HBL, commercial invoice, and other required documents to determine if record is available Corresponding with overseas agents and clients Working with steamship lines/airlines/trucking companies to obtain quotations and handle the movement of freight Developing and maintaining excellent customer service to internal and external customers Preparing quotations Handling the files from A to Z Responsible to ensure legal compliance, provide import guidance and control within government rules and regulations. Job Requirements: Minimum 2- 4 years of experience in Import Customs Clearance operations Knowledge of current and historical Customs regulations, Harmonized Tariff Schedule, and related directives of government agencies (including but not limited to Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and United States Agriculture Department (USDA) is a plus) Be able to work independently, multi-task, be a team player and work in a fast-paced environment Possess excellent written and verbal communication skills Have computer skills and knowledge of Microsoft Outlook, Excel, Word and Access Experience with the handling of hazardous materials a plus

Job DescriptionJob Title: REMOTE Territory Sales Manager – Specialty Chemicals & APIsCompensation: $100,000–$130,000 base + performance incentives Location: Remote (U.S.) Industry: Specialty Chemicals / APIs / Pharmaceutical Intermediates Overview A global manufacturer of specialty chemicals and pharmaceutical ingredients is expanding its North American commercial team. This is a high-impact sales role focused on growth within key verticals including iodine derivatives, intermediates for anti-cancer and contrast media, and active pharmaceutical ingredients (APIs). The role is modeled on a proven sales structure used for similar markets, emphasizing relationship management, business development, and strategic positioning across nutraceutical, pharma, and fine chemical sectors. Key Responsibilities * Drive sales growth across the North American territory for specialty and pharmaceutical-grade chemical ingredients. * Identify, target, and close new business opportunities across the following categories: * Iodine derivatives * Anti-cancer drug intermediates * X-ray and contrast media intermediates * APIs and stomach-related APIs * Develop and maintain relationships with key accounts, distributors, and manufacturers. * Collaborate closely with global production and regulatory teams to ensure compliance and delivery. * Analyze market trends and identify high-value prospects for long-term partnerships. * Represent the company at key trade shows and industry events (e.g., IBIE, CPhI, SupplySide West). * Prepare detailed reports and forecasts for executive management. Qualifications * Bachelor’s degree in Chemistry, Chemical Engineering, or related field (advanced degree a plus). * Minimum 5 years of experience in B2B sales of specialty chemicals, APIs, or pharmaceutical intermediates. * Proven track record of achieving revenue goals and building strategic partnerships. * Familiarity with regulated markets (FDA, REACH, GMP) preferred. * Exceptional communication, negotiation, and presentation skills. * Self-motivated, entrepreneurial mindset; able to operate with minimal supervision. Compensation & Benefits * Base salary between $100,000 and $130,000, depending on experience. * Performance-based commission and annual bonus structure. * Health coverage, paid time off, and travel reimbursement. * Long-term growth opportunity with a global chemical leader expanding in the U.S. market.

Job DescriptionCompliance Investigator, Clinical ManufacturingAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Compliance Investigator, Clinical Manufacturing leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS degree in a Quality/ Process related field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • 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, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Quality Systems Training (Deviation/CAPA)Working Environment While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionDescription: Leading Freight Forwarder / NVOCC/ Customs House Broker/ Tank Container Operator, with locations in 24 countries and over 3300 employees strong, is seeking a highly motivated and organized individual to fill the position of Import Customer Service Representative – Customs Entry Writer in our Jersey City, NJ office. Responsibilities include but are not limited to: • Preparing and submitting customs entries: This involves preparing the necessary documentation and data to US Customs and Border Protection (CBP) and other government agencies like the FDA, Fish & Wildlife Service (FWS), USDA, etc., • Transmission of Customs Entries to U.S. Customs for import shipments, • Ensuring compliance: Verify accuracy of documents (commercial invoices, etc.) and ensure compliance with US Customs regulations., • Coordinating with various parties: Communicate and coordinate with internal / external customers, carriers, freight forwarders, customs officials and other agencies to ensure smooth clearance of good, • Problem-solving: Resolve documentation discrepancies, Customs exams, FDA holds, or other issues related to Customs clearance., • Receiving, reviewing, and processing import documentation for an assigned base of accounts, • Preparing daily activities including: preparing delivery orders and coordinating the pickup and delivery of cargo, filing ISF (Importer Security Filing), answering emails, • Processing documents through the system and interface and providing updates and communications for internal and external customers to produce timely and compliant transactions, • Tracing key transaction information such as HBL, commercial invoice, and other required documents to determine if record is available, • Corresponding with overseas agents and clients, • Working with steamship lines/airlines/trucking companies to obtain quotations and handle the movement of freight, • Developing and maintaining excellent customer service to internal and external customers, • Preparing quotations, • Handling the files from A to Z, • Responsible to ensure legal compliance, provide import guidance and control within government rules and regulations. Requirements: Job Requirements: · Minimum 2- 4 years of experience in Import Customs Clearance operations · Knowledge of current and historical Customs regulations, Harmonized Tariff Schedule, and related directives of government agencies (including but not limited to Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and United States Agriculture Department (USDA) is a plus) · Be able to work independently, multi-task, be a team player and work in a fast-paced environment · Possess excellent written and verbal communication skills · Have computer skills and knowledge of Microsoft Outlook, Excel, Word and Access · Experience with the handling of hazardous materials a plus Our Benefits include: · Medical · Dental · Vision · Flexible Spending Account (Medical and Dependent Care) · 401(k) with company match · Company paid Life Insurance, Short-Term Disability and Long-Term Disability · Paid Holidays plus PTO and Sick Leave · Voluntary Time Off · Employee Assistance Program · Tuition Reimbursement · Employee Referral Program · Employee Discounts When applying, the candidate should include salary requirement. Background check required. Only those considered for the position will be contacted. Thank you for your interest.

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 DescriptionCompany Description Leap Consulting Group supports clinical diagnostics and clinical research organizations through a full range of services supporting the end-to-end digital and technology needs of the lab, from the digital front door to the pre-analytical lab bench process (LIMS, instrumentation, automation, etc.), and all of the complex processes for report writing, revenue cycle, and patient engagement before and after testing. Leap provides turnkey services starting with strategic planning through full implementation and everything in between for CLIA, CAP, NYS CLEP, and FDA-compliant laboratories. Leap’s lab practice is led and staffed by veteran laboratory leaders from high-volume, high-complexity laboratories across the United States. In addition to lab-centric capabilities, Leap offers full capabilities across digital, cloud, and the rest of the IT ecosystems. Job Description We’re looking for experienced laboratory professionals — former bench technologists, R&D scientists, or lab operations specialists — who are excited to apply their laboratory expertise to be client-facing and working directly on client lab projects building the latest and greatest in clinical laboratory workflows and laboratory software system implementations. This is a hands-on, problem-solving role — you’ll work alongside scientists, engineers, and clinicians to make lab systems work better, not sell software or convince people why they need to do better - everyone is working together to make it better. This role is not a generic IT business analyst position — it’s designed for individuals with deep understanding of how labs actually function, from sample accessioning to reporting. If you have great IT analyst skills we need those too, but we are currently not hiring for those. Please do not apply here if you are not deeply experienced in clinical laboratory and/or LIMS. This is a role reporting into our Healthcare Practice Lead focused on supporting several laboratory initiatives including digital-front-doors, preanalytical systems, LIMS, lab automation, bioinformatics, revenue cycle, and other related needs. The role requires Laboratory Operations and/or Laboratory IT awareness, a background in digital transformation or information systems, and ideally exposure to clinical laboratory revenue cycle. The person in this role would be a smart, inquisitive, experienced clinical laboratory or health system technology business analyst or functional technical analyst. From Buy vs. Build Analysis, to System Sourcing projects, to big picture planning, and down to the real roll-up-your-sleeves implementation requirements gathering, technical design, and partnering with your software engineering peers to deliver solutions. In this position, you will work closely with Leap client’s business, clinical, and technology leaders to understand their needs, design and develop innovative solutions, and tackle complex challenges. The people in this role will help clients articulate their requirements, prioritize their needs, develop detailed specifications, and at times will lead implementations in Agile methodologies often supporting a mixed team of both Leap provided and client employee engineering resources. The ideal candidate will be well spoken, extremely organized, and able to succinctly capture every detail. You should also be able to ask questions to clients to ensure there are no gaps in the analysis conducted and be an effective communicator when there have been changes in the requirements. As is the nature of digital transformation consulting, the right people for this role find themselves adaptable and flexible in an environment where change is the only constant. The ideal candidate finds clarity in ambiguity and shifts priorities quickly as new client considerations, challenges, and opportunities arise. You should excel in managing projects, driving product development, and analyzing business needs, all while thriving in a fast-paced and collaborative environment. This role is a hybrid position based in our Bergen County NJ offices. Hybrid expectations include 4 days a week in office, 1 day remote, exclusive of client-related-travel which would be as required. Key Responsibilities: * Portfolio and Program Management: * Partner with clients to define a product or program vision, strategy, and roadmap in alignment with business goals and stakeholder needs * Business Analysis: * Able to understand complex lab workflows and communicating future state changes to developers * Perform gap analysis to identify discrepancies between current processes and desired outcomes * Translate bench-side workflows into system requirements * Document process maps that mirror the flow of specimens through the lab * Collaborate with engineers to digitize and automate R&D and QC processes * Be able to handle changes in workflow and how to address them when those blockers occur * Facilitate meetings to gather requirements, develop solution plans, and drive alignment with business stakeholders * Participate in detailed design sessions with the technical teams to define the implementation approach based on requirements gathered * Project Management: * Handle project ambiguity, complexity, and interdependencies with an organized and structured approach * Assess and prioritize new information and requirements, integrating them seamlessly into project deliverables * Identify and manage project risks and issues * Maintain project documentation, ensuring all project deliverables are documented, updated, and communicated effectively * Facilitation & Communication: * Maintain situational awareness and resolve conflicts efficiently to keep projects on track * Ensure clear and effective communication across all levels of the organization * Adaptability & Creative Problem Solving: * Demonstrate a proactive approach to identifying and addressing challenges * Embrace and manage chaos with a continuous learning mindset, adapting to evolving requirements and challenges * Detail Orientation & Strategic Vision: * Dive into the details to ensure precision and accuracy while maintaining a strategic, high-level perspective * Communicate complex technical concepts in a way that is accessible to non-technical stakeholders, effectively bridging the gap between technical and business perspectives * Stay strategic without losing the detail - it is an art more than a science * Execution & Results: * Demonstrate dependability and reliability with a focus on clear thinking and meticulous attention to detail * Produce detailed stories to drive development and be reliable for QA testing If you are an energetic and multifaceted professional who can embrace uncertainty, think on their feet, and effectively manage shifting priorities to drive projects forward, with the ability to navigate both technical details and strategic business goals, we encourage you to apply and help us drive impactful solutions for our clients! Keywords: LIMS, LIS, ELN, middleware, automation, genomics, pathology, molecular diagnostics, assay development, quality control, sample tracking, data integrity, CLIA, CAP, HL7, FHIR, lab workflow optimization Qualifications Minimum Qualifications: * Education: BA/BS Required * Experience: Minimum of 3-5 years working at the bench and/or as a Business Analyst or Functional Technical Analyst, preferably in a clinical laboratory * Be comfortable communicating in-person, by phone, over video, as well as collaboration chat tools such as Slack and Teams * Be a self-starting independent team player who is both professional and kind to colleagues and customers * Be tech savvy and ideally consider yourself 'fairly technical' * Proven experience in project management, product management, and business analysis * Strong facilitation, communication, and conflict resolution skills * Ability to manage multiple projects simultaneously and prioritize tasks effectively * Ability to manage complexity and ambiguity in a structured and organized manner * Demonstrated ability to drive results and deliver innovative solutions * Proficiency in discussing technical details and translating them into business value * Experience in performing gap analysis and creating business process flows Preferred Qualifications: Knowledge, experience, or proficiency in most or all of the following: * Acting as a liaison between technical operations and solutions providers * Documenting, analyzing, and recommending solutions to complex problems * Information Technology and Software Development business cycles * Healthcare Digital Physician and/or Patient Portals * Revenue Cycle Management * Laboratory Operations * Bioinformatics Additional Information • Be comfortable communicating in-person, by phone, over video, as well as collaboration chat tools such as Slack, • Be a self-starting independent team player who is both professional and kind to colleagues and customers

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 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 DescriptionThis is a temporary 6-month contracted 1099 position with no benefits. The pay range for this position is $70-$85/hr (depending on prior experience) Job Functions: • Applies expertise as an emerging authority in the mechanical engineering discipline., • Conceives and develops solutions to difficult analytical and pneumatic/mechanical/electrical design problems., • Participates in establishing system or component design objectives and writes portions of complex specifications and engineering reports., • Reviews and helps to develop product specifications, • Conducts conceptual design studies using MCAD and other applicable design tools. Collaborates with other engineering functions, • Develops prototype hardware using internal manufacturing resources and outside vendors, • Tests product to verify that designs meet specification requirements such as environmental, regulatory and safety requirements, • Generates documentation supporting the design, • Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software., • Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable., • Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable., • Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data., • Experience with electronic document control systems in medical device and/or medical equipment design and development., • Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis., • Ability to create and meet scheduled timelines (manage and coordinate tasks as required)., • Ability to work in a team environment., • Strong communication skills., • Familiarity with dimensioning and tolerance, thermal and structural analysis, and vibration testing/analysis, • Intermediate knowledge of FDA, IEC and UL standards relating to medical electronic equipment, • Strong technical and analytical ability, verbal and written communication skills, ingenuity and creativity, interpersonal and project management skills, • Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM’s and oscilloscopes, • BSME or MSME and a minimum of 10 years of related experience in design/product development of electro pneumatic assemblies including technical supervision of sub-projects, • Formal training in basic and advanced topics in Solid Works is strongly preferred, • Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat, • Advanced proficiency with SolidWorks, MCAD/CAE software and database management software preferred, • Advanced proficiency with Microsoft Visio and Microsoft Project preferred Important Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to . Powered by JazzHR X8pVqY29x5

Job Description Hudson Regional Health System (HRHS) seeks a results-driven and collaborative laboratory leader to oversee diagnostic and clinical laboratory operations for Bayonne University Hospital and Secaucus University Hospital. The Director is accountable for ensuring regulatory compliance, service quality, and operational efficiency across both campuses, supporting HRHS’s mission of delivering exceptional, patient-centered care. Position Summary The Director manages all inpatient and outpatient laboratory functions for Bayonne and Secaucus hospitals, including technical operations, staffing, compliance, and financial performance. The position ensures consistency, quality, and innovation across both campuses while supporting HRHS’s broader laboratory strategy. This position reports directly to the System Chief Operating Officer. Key Responsibilities • Oversee daily operations of clinical laboratory services across Bayonne and Secaucus facilities., • Ensure full compliance with CLIA, CAP, Joint Commission, OSHA, FDA, and applicable state regulations., • Supervise laboratory leadership teams, including supervisors, and technical personnel., • Maintain appropriate staffing, scheduling, and budgetary controls to ensure cost-effective performance., • Collaborate with hospital executives, medical directors, and clinical departments to support patient care initiatives., • Lead continuous quality improvement and performance optimization efforts across both sites., • Manage equipment procurement, service contracts, and laboratory supply chains., • Partner with IT and system teams to standardize data, reporting, and laboratory information systems., • Track and report KPIs, turnaround times, and quality metrics to system leadership., • Serve as the administrative and operational leader for laboratory services at Bayonne and Secaucus campuses., • Collaborate directly with the System COO and other hospital executives to align goals and share best practices., • Work closely with other HRHS laboratory leaders to advance system standardization and integration., • Bachelor’s degree in Clinical Laboratory Science, Medical Technology, or related field required; Master’s degree preferred., • Current licensure and national certification (ASCP, NCA, or AMT) required., • Minimum 7 years of progressive experience in laboratory management, including multi-site leadership preferred., • Reference Lab experience preferred., • Deep understanding of regulatory requirements, budget management, and process improvement methodologies., • Exceptional interpersonal and leadership skills, with the ability to collaborate effectively across departments.

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 We are Licensed Customs House Brokers looking for a highly motivated, customer service oriented data entry clerk. The hours are from 8:30 to 5:00. Import Entry Specialist - TCRS4556 HIGH LEVEL OVERVIEW The Import Entry Specialist is responsible for the timely and accurate filing of customs entries ensuring compliance with CBP and other government regulations. This is an on-site position based in Englewood Cliffs, NJ. EXPECTATIONS • Prepare, review, & process import entry documentation for air/ocean shipments and border crossings, • Work with CBP and other government agencies to resolve any compliance issues, holds, or queries, • Work with internal and external partners to provide timely clearance updates, • Maintain and manage client product database with HTS classification, • Stay current with changes to regulations and understand the impact to import entry processes, • Knowledge of U.S. Customs regulations; HTS Classification, COO, Valuation, • 3 years’ Customs Brokerage experience preferred, • Strong attention to detail, accuracy in data entry, and time-management skills, • Organizational skills and the ability to multitask in a fast-paced environment, • Understanding of FDA, DOT, and LACEY import regulations, • Knowledge of trade automation tools; CargoWise, ACE, etc., • Experience with import entry software, ideally Decartes/NetCHB, • Experience in Microsoft applications- Excel, Word, PowerPoint, OutlookCompany DescriptionLicensed Customs House BrokerLicensed Customs House Broker

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

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: • Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs), • Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity, • Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data, • Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents, • Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports), • Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC, • Demonstrated ability to lead others to complete complex projects, • Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines, • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment, • Organizational expert within the nonclinical subject area, • Excellent written/oral communication and strong time and project management skills, • Ability to attend regular team meetings, lead client meeting and CRMs, • Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars, • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)Requirements:, • BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control, • Knowledge of GLP, ICH guidelines, and applicable regulatory requirements, • 2+ years of pharmaceutical regulatory nonclinical writing experience, • Strong writing and analytical skills, • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred uuQhjdtYkG

Job DescriptionJob Title: Adobe Campaign Lead Developer Location: U.S.-based (onshore). Hybrid/remote (Preferred but not restricted to Philadelphia or Atlanta USA). Type: Full-time, client-facing Role Summary Lead end-to-end strategy and execution of email and direct mail programs on Adobe Campaign (v8/Classic) for a major telecommunications client. Own campaign intakebuildQAlaunchreporting, guide an offshore/onshore pod, and partner with marketing, data, and CRM teams to deliver timely, compliant, high-impact communications. Key Responsibilities • Campaign leadership: Own calendar, briefs, targeting rules, build/QA, and launches for Email & Direct Mail; ensure on-time, error-free delivery with clear stakeholder updates., • Audience & personalization: Translate business asks into segments and dynamic content using Adobe Campaign data model and templates; manage suppressions/seed lists and opt-in/opt-out compliance., • Direct Mail orchestration: Coordinate list pulls, QA, creative specs, vendor handoff, and match-back reporting for DM alongside digital touchpoints., • Cross-functional partnership: Work with client data/analytics teams to ensure smooth execution across martech., • Governance & quality: Uphold brand, legal, and privacy standards (CAN-SPAM/GDPR/CCPA); maintain documentation, playbooks, and campaign audit trails., • Excellent stakeholder communication, prioritization, and project leadership in a fast-paced, enterprise environment., • Strong segmentation and campaign workflow experience; comfortable translating requirements into executable builds and QA plans., • Working knowledge of SQL for audience creation and troubleshooting; comfort with HTML/CSS for email template QA., • Familiarity with integrations across CRM systems (Salesforce/Microsoft Dynamics) and Adobe stack (AEP/Analytics/Target) is a plus.Nice to Have - Adobe Campaign certification (ACE), experience with transactional/real-time messaging, and exposure to FDA/API/SFTP integrations. This is a remote position.

Job DescriptionQC Analytical Compliance Investigator Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Our client is seeking a QC Analytical Compliance Investigator to lead life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field., • Experience in GMP Operations and/or QA in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • 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, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • GMP Trained, Quality Systems Trained (Deviation/CAPA)Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. 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. Physical RequirementsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Other DutiesPlease 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 DescriptionJOB DESCRIPTION:The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES:Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS:5+ years of pharmaceutical experience Must have experience with Radiopharmaceuticals and Quality BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

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

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

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

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Join Our Team at Bergen New Bridge Medical Center!** We are dedicated to providing high-quality, compassionate care to our diverse community. As a leading healthcare provider, we offer a supportive and inclusive work environment. If you’re passionate about making a difference and thrive in a collaborative setting, Bergen New Bridge Medical Center is looking for a Mammography Technologist. Job Duties Performs and obtains high quality mammograms on all patients (i.e. In-Patients, Clinic or Private Outpatients); recognizes the need for and utilizes radiation protection measures as appropriate in accordance with departmental policies. As required, transports patients to and from mammography rooms. Assists the Radiologist with needle localizations. Properly utilizes all mammography equipment permitted within the scope of their license and within the realm of their training. Assessment, treatment and patient care responsibilities are delivered with a knowledge of patient growth and development and are appropriate to the ages of the patients served. Ability to perform and maintain quality management as required by the FDA and MQSA. Customer Service: respect, flexibility, knowledge, confidence, professionalism, pleasant attitude, patience and helpfulness. All responses should be timely, professional, caring, and respectful in accordance with Customer Service Performance expectations Maintains established departmental policies and procedures, objectives, quality assurance program, safety, environmental, and infection control standards. Assesses gaps in policies and procedures, and create necessary policies and procedures to fulfill these gaps. Understands and adheres to the Medical Center’s Code of Conduct. Familiar with the Medical Center’s Mission, Vision, and Values Statements. OTHER JOB DUTIES Develops all X-rays when required. Provides patient comfort (e.g., bedpans, blankets) as required. Performs required clerical work when necessary to maintain patient records. Maintains a clean and orderly environment to include; Mammography room and equipment, and Mammography processor and dark room. Informs appropriate personnel when equipment is in need of repair. Fulfills all continuing education requirements specified by regulatory agencies and Medical Center standards. Performs other related duties as required. BASIC COMPETENCIES Education/Licensure Graduation from an AMA approved School of Radiologic Technology; ARRT or Registry eligible. Current NJ license as a Licensed Radiologic Technologist. Mammography registry. American Heart Association Heart saver CPR/AED certification. Experience None Skills Good interpersonal skills. Speaks, reads and writes English to the extent required by the position. JOB SETTING/PHYSICAL DEMANDS Diagnostic Imaging Department; contact with staff, patients. Lifts, positions and/or transfers patients. Frequent prolonged standing. Lifts/moves x-ray equipment. Protective clothing worn: gloves, gown, lead apron. Salary commensurate with experience within posted range. $38.46-$43.07 DIFFERENTIALS EVE/NIGHT $2.40/ WEEKEND $1.75 We provide a comprehensive benefits package, including a competitive medical, dental, and vision plans. We prioritize work-life balance with a generous time off policy that includes ample vacation days, personal time, sick leave and nine paid holidays. Additionally, we are committed to the personal and professional growth of our employees, offering robust tuition reimbursement and continuing education programs to help support our employees ongoing development. Company DescriptionBergen New Bridge Medical Center, a clinical affiliate of Rutgers Biomedical and Health Sciences, is a 1,070 bed hospital located at 230 East Ridgewood Avenue in Paramus, NJ. Founded in 1916 to treat patients with contagious diseases, the medical center has grown to become both the largest hospital and licensed nursing home in New Jersey and the fourth-largest publicly-owned hospital in the nation. A safety net facility, Bergen New Bridge Medical Center, renamed in October 2017, provides high-quality comprehensive services including long term care, behavioral health care, substance abuse treatment, and acute care to the greater Bergen County community. The medical center, including its Long Term Care Division, is fully accredited by The Joint Commission. With 323 behavioral health beds and 84 medical detox beds, Bergen New Bridge Medical Center is one of the largest medical facilities providing a continuum of care for those in need of behavioral health and/or substance abuse treatment. Please apply on our website: New Bridge Medical Center, a clinical affiliate of Rutgers Biomedical and Health Sciences, is a 1,070 bed hospital located at 230 East Ridgewood Avenue in Paramus, NJ. Founded in 1916 to treat patients with contagious diseases, the medical center has grown to become both the largest hospital and licensed nursing home in New Jersey and the fourth-largest publicly-owned hospital in the nation. \r\n\r\nA safety net facility, Bergen New Bridge Medical Center, renamed in October 2017, provides high-quality comprehensive services including long term care, behavioral health care, substance abuse treatment, and acute care to the greater Bergen County community. The medical center, including its Long Term Care Division, is fully accredited by The Joint Commission. With 323 behavioral health beds and 84 medical detox beds, Bergen New Bridge Medical Center is one of the largest medical facilities providing a continuum of care for those in need of behavioral health and/or substance abuse treatment.\r\n\r\nPlease apply on our website:

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. In Japan. Summary: Manage and support the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. Essential Duties and Responsibilities: • Assist to plan, implement, manage and report for regional or global clinical studies., • Manage selection process of CROs for regional or global clinical studies., • Manage the performance of study vendors (e.g. CROs and central labs), • Manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans, • Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.), • Tracking of 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., • Coordinate negotiation of clinical trial contracts between investigational sites and CROs., • Manage assigned vendors to ensure timely analysis output delivery in accordance with vendor-specific plan., • Support 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, • Support creating and maintaining clinical SOPs and TMF as part of global QMS and TMF processes., • Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.)., • Must be able to manage and coordinate with the Clinical Lead and Study Manager to achieve project objectives and able to manage/solve project management performance issues if they arise., • Demonstrated ability to support the development and management of various aspects of the end to end study operational plan., • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners and vendors., • Thorough understanding of clinical operations involved as related to the planning, conducting, and closing clinical studies., • Ability to handle multiple tasks and prioritize., • Strong organizational, communication and presentation skills., • Team player, flexible, ability to adapt to change., • Bachelor’s Degree in sciences or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience., • Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials., • Program and project management experience preferred. Compensation And Benefits: 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 $110,000 to $135,000; 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, • Flexible Work Arrangement Programs Applications will be accepted until January 19, 2025, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Job Description Position Overview: Hudson River Imaging is seeking a skilled and compassionate Mammography Technologist to join our team. The ideal candidate will be experienced in operating the Siemens Revelation mammography system, dedicated to delivering high-quality patient care, and committed to maintaining the highest standards of imaging and safety in accordance with ACR, MQSA, and state guidelines. Key Responsibilities: * Perform screening and diagnostic mammography examinations using the Siemens Revelation system. * Ensure optimal image quality while minimizing radiation exposure in compliance with ALARA principles. * Prepare and position patients for mammographic procedures, ensuring comfort, dignity, and safety. * Verify patient identification, review medical history, and explain exam procedures. * Collaborate with radiologists, technologists, and clinical staff to support timely and accurate diagnoses. * Perform daily quality control and equipment checks in accordance with ACR and FDA requirements. * Maintain accurate patient records and documentation in PACS/RIS. * Stay current with new mammography techniques, regulations, and continuing education requirements. Qualifications: * ARRT (R)(M) certification required. * Current state radiologic technologist license. * Minimum 1 year of experience in mammography; Siemens Revelation system experience strongly preferred. * Knowledge of ACR accreditation standards and MQSA compliance. * Strong interpersonal and communication skills with a focus on patient-centered care. * Ability to work independently and collaboratively in a fast-paced imaging environment. Preferred Experience: * Familiarity with tomosynthesis (3D mammography) workflows. * Experience assisting with breast biopsy procedures a plus. Why Join Us: * Work with state-of-the-art imaging technology, including Siemens Revelation mammography systems. * Supportive, team-oriented environment focused on excellence in patient care.

Job Description Overview Amerita is an entrepreneurial-founded company and a wholly owned subsidiary of PharMerica. The home infusion market is positioned for rapid growth driven by the aging population, increase in chronic diseases, robust pipeline of infusible drugs coming to market, and an industry shift from hospital delivery settings to lower-cost, high-quality alternative providers such as Amerita. Prepares technical and clerical tasks associated with the preparation, labeling and dispensing of pharmaceuticals. Plays an integral role in the inventory and quality assurance activities. Schedule: Monday - Friday 9:00am - 5:30pm • Competitive Pay, • Health, Dental, Vision & Life Insurance, • Company-Paid Short & Long-Term Disability, • Flexible Schedules & Paid Time Off, • Tuition Reimbursement, • Employee Discount Program & DailyPay, • 401k, • Pet Insurance Responsibilities • Coordinates and facilitates new referrals and admissions through collaboration with nurses, customer service and distribution, • Conducts and documents initial and ongoing assessment of specific patient, drug and disease information to identify real and potential drug-related problems or needs, • Escalates to a clinician as needed, • Answers inquiries from patients, families, physicians and other healthcare professionals. Escalates to a clinician as needed, • Maintains thorough and appropriate documentation in the customer/patient record of all clinical activities and communication with patients, physicians and other healthcare professionals, • Coordinates and schedules the preparation of IV therapies and home medical equipment orders with the assistance of the Pharmacist, • Helps coordinate patient care activities with Pharmacists, Nurses, other Technicians and Patient Care Coordinators, • Prepares labels, prescriptions and compounding/mixing worksheets and completes and maintains product lot numbers, expiration dates and batch records, • Generates delivery/pick slips under the supervision of the Pharmacist. Picks and pulls supplies and home medical equipment, • Obtains supply inventories from patients/clients and communicates information obtained to the Pharmacist as required and documents all communication in patient progress notes on the pharmacy computer system, • Participates in branch management, department and intra-departmental meetings and quality improvement activities, • Adheres to all accreditation, OSHA, FDA, state, local and federal regulations and standards relevant to infusion pharmacy and home medical equipment, • Other duties as assigned, • Supervisory Responsibility: No Qualifications • Successful completion of an approved/accredited pharmacy technician training program; IV certification preferred, • Registered Pharmacy Technician license in state of practice per state regulations, • National Pharmacy Technician Certification as required by the state board of pharmacy in state of practice, • One to three (1-3) years of related pharmacy experience in a home care setting, retail, or pharmacy setting, • General knowledge of drug terminology, pharmaceutical calculations, drug use and aseptic techniques, • Flexible schedule with the ability to work on-call evenings and weekends on an as-scheduled basis, • Effective mathematical and communication skills required, • Basic pharmacy knowledge of reading and interpreting prescriptions, • Ability to work independently, accurately, and efficiently, • Valid driver’s license, preferred Driving Position: Yes To perform this role will require constant sitting and typing on a keyboard with fingers, and occasional standing, and walking. The physical requirements will be the ability to push/pull and lift/carry 10-30 lbs

Job Description We are conducting a search for an experienced Director of Quality Control / Quality Assurance to lead and manage our quality programs in a fast-paced, high-volume food manufacturing environment. The ideal candidate is a certified SQF Practitioner with a proven track record of successful third-party, regulatory, and customer audits, and extensive experience in both foodservice and retail segments. This leadership role is critical to ensuring our products consistently meet the highest standards of safety, quality, and compliance. What You'll Do: • Direct and oversee all QC/QA activities across food manufacturing operations., • Maintain and improve the company’s SQF program; act as the designated SQF Practitioner., • Lead all audit activities (SQF, FDA, , customer, and third-party), ensuring successful outcomes and timely resolution of non-conformities., • Implement and monitor HACCP plans, food safety systems, GMPs, SOPs, and other quality-related programs., • Supervise and develop the QA/QC team; drive a culture of accountability and continuous improvement., • Partner with cross-functional teams including Operations, R&D, and Supply Chain to optimize product quality and efficiency., • Ensure thorough documentation, traceability, and compliance across all quality-related functions., • Manage and respond to customer complaints, deviations, and corrective/preventive actions (CAPAs)., • Monitor industry trends and regulatory updates to ensure ongoing compliance. What You'll Bring: • Bachelor’s degree in Food Science, Microbiology, or related field., • Certified SQF Practitioner (REQUIRED)., • Minimum 10 years of QA/QC experience in the food manufacturing industry, with leadership responsibilities., • Demonstrated success managing quality in both foodservice and retail channels., • Proven track record of passing regulatory, third-party, and customer audits., • Deep understanding of HACCP, GMPs, FSMA, FDA regulations., • Strong organizational, communication, and leadership skills., • Ability to thrive in a high-speed, hands-on manufacturing environment., • Experience with refrigerated, shelf-stable, or specialty food products is a plus., • Bilingual (English and Spanish) is a plus

Job Description Our client is seeking a CMC Writer to join their team. & SUMMARY: • Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. JOB DESCRIPTION: • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files KEY RESPONSIBILITIES: • Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format., • Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals., • Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions., • Ensure compliance with FDA, EMA, and ICH guidelines and internal processes., • Collaborate with cross-functional teams to gather accurate technical information., • Identify and communicate potential regulatory risks; propose mitigation strategies. QUALIFICATIONS: • Education: Bachelor’s or advanced degree in Chemistry, Pharmaceutical Sciences, or related field., • Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management., • Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities., • Familiarity with global regulatory frameworks and eCTD submissions., • Excellent technical writing, communication, and organizational skills., • Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint). PREFERRED SKILLS: • Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings., • Ability to interpret and apply regulatory guidelines effectively., • Strong project management and stakeholder communication skills.

Job Description Director, Business Development - Clinical Research Director, Clinical Business Development Full Time Remote-USA Based Reports to: Senior Vice President, Clinical Services Frontage Laboratories Inc. Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials. Frontage Clinical Services At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion. Responsibilities: • Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers, • Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes, • Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization, • Ensure appropriate strategy/solution is proposed to clients, • Monitor actions and results against plans, • Lead client visits to the Frontage facilities, • Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities, • Monitor sponsor satisfaction by regular communication with the clients/sponsors, • Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (salesforce) system, • BS degree or above, life science preferred., • 3+ years’ experience in a clinical operation role and /or 1+ years’ experience selling early-stage clinical research services., • Solid understanding of the principles of drug discovery and development., • Knowledge and experience in DMPK & Safety Toxicology, • Knowledge and understanding of FDA, GCP, and ICH regulations and guidance, • Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel., • Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities., • Excellent oral and written communication skills., • Ability to travel.

Job DescriptionThis position will report into the Manager of QC Analytical. The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control and technical standards. The QC Analytical Supervisor will also provide oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Schedules and monitors daily operation of department based on projected client demands., • Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices., • Approval of investigations and documentation of non-confirming events and OOS., • Recommends process improvements to achieve greater efficiency within the department and between sites., • Participates in department and cross functional meetings., • Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness., • Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Direct reports: QC Analysts (Approximately 8-10 reports), • Other duties as assigned.REQUIREMENTS, • BS degree in Science or relevant field;, • 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent., • Strong knowledge of FDA and EU regulatory standards. cGMP experience required., • Strong knowledge of analytical test methods and philosophies., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office and LIMS, • Competencies/Candidate Profile, • Acts decisively, • Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively., • Builds and maintains relationships, • Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders., • Communicates effectively, • Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback., • Fosters continuous improvement and innovation, • Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies., • Fosters integrity and honesty, • Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically., • Supervises and manages performance, • Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues., • Manages projects and functions, • Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs., • 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 using a performance management and development processes to include goal setting, feedback, and performance development planning., • Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication., • GxP/GDP TrainingWorking EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Must have the ability to work with specialized equipment.The employee must be able to comply with the company's personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification as well as annual re-qualification as a core competency requirement of their employment in this role. 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: • Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities., • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files, • Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format., • Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals., • Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions., • Ensure compliance with FDA, EMA, and ICH guidelines and internal processes., • Collaborate with cross-functional teams to gather accurate technical information., • Identify and communicate potential regulatory risks; propose mitigation strategies., • Education: Bachelors or advanced degree in Chemistry, Pharmaceutical Sciences, or related field., • Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management., • Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities., • Familiarity with global regulatory frameworks and eCTD submissions., • Excellent technical writing, communication, and organizational skills., • Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint)., • Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings., • Ability to interpret and apply regulatory guidelines effectively., • Strong project management and stakeholder communication skills.

Job Description TRADE COMPLIANCE SPECIALIST TCRS4481 HIGH LEVEL OVERVIEW The Trade Compliance Specialist will be the subject matter expert for all trade compliance related topics and activities ensuring compliance with customs rules and regulations. This position is in-office near Wayne, NJ. EXPECTATIONS • Prepare and review shipping documents; commercial invoice, certificate of origin, packing list, • Manage and maintain accurate records for all import/export activities, • Conduct risk assessments to identify issues and create mitigation strategies, • Collaborate with cross-functional teams to enhance trade compliance procedures, • Stay up to date on trade regulation changes and industry standards, • Work with Brokers, Customs, and other government agencies to resolve clearance issues, • Develop procedures, work instructions and training to provide trade compliance guidance ESSENTIALS • 3-5 years' trade compliance experience, • Licensed Customs Broker required, • Bachelor's Degree preferred, • Thorough understanding of HTS Classification, Country of Origin, Valuation, Free Trade Agreements, • Knowledge of U.S. and Canadian Customs and PGAs regulations (FDA, EPA, FWS, etc), • Experience working with Customs Brokers and clearing import entries, • Expertise with Excel required including pivot tables and VLOOKUP, etc., • Effective problem solver with strong data and analytic skills, • Experience working with Customs brokers and clearing import entries

Job Description Job Duties: Performs and interprets automated and manual testing procedures on blood, urine and fluid specimens in the laboratory. Evaluates specimen/test orders for acceptance/rejection according to guidelines; accessions specimens accurately. Meets established TAT and productivity standards. Recognizes and resolves errors/discrepancies or problems and notifies appropriate personnel. Is proficient with all IT systems; can order, cancel, retrieve result, review work lists, sample collections, and test status. Addresses critical results and delivers STAT results properly according to policy. Correlates results with diagnosis and compares previous results if necessary. Can operate all Laboratory testing instruments; can recognize, troubleshoot and resolve instrument issues. Ensures proper function, maintenance and QC of each instrument; ensures compliance with QC, maintenance, temperature and reagent records. Performs proficiency testing and quality audits as needed. Ensures compliance with JCAHO, FDA, CAP, AABB and NJDOH. Maintain the record of reagents and supply; reports reagents shortage to the supervisor or designee; ensures that all reagents used for testing are in date and show no signs of drift or contamination as indicated in the daily QC data. Assists with training new employees, participates in teaching students. Demonstrates knowledge and follows to all department safety procedures and policies. Ensures proper handling of chemical and bio-hazard materials. Works weekdays, weekends and holidays as scheduled. Conducts personal business on non-productive time, limits socializing to ensure the work flow continues uninterrupted. Shows leadership quality; assumes responsibility in absence of supervisor. Attends department meetings and participates in continue education. EDUCATION + EXPERIENCE REQUIREMENTS: BS degree from an accredited institution with a major in medical technology. Minimum of 1 year clinical laboratory experience, which may be concurrent or subsequent to education, required. MT (ASCP) or equivalent certification desired. May be required to meet specific state requirements. CREDENTIALS + QUALIFICATIONS: Degrees from foreign institutions will require credential equivalency evaluation. Ability to provide excellent customer service internally and externally. Possess superior written and verbal communication skills. Ability to read, understand and follow detailed procedures. Analytical, numerical and reasoning abilities necessary. Proven skills of critical thinking, problem solving, and decision making. Ability to prioritize, organize, and handle a high volume workload efficiently essential. Good close vision and color perception required.

Certification Details • BLS, • ARRT, • Diagnostic Radiography License, • Mammography Certification (required within 3 months)Job Details, • The Mammography Technologist is responsible for performing mammography examinations following ACR requirements., • Assists with breast ultrasound, stereotactic biopsy, breast localization and other radiologic guided procedures within the Breast Center., • Performs diagnostic and screening mammographic examinations on adult, adolescent, and geriatric patients., • Performs mammographic imaging for breast needle localization and stereotactic procedures including setup and cleanup., • Assists in procedures using ultrasound guidance., • Provides immobilization devices, selects proper technical factors based on patient needs, and operates equipment for specific procedures., • Identifies patient films correctly with name, x-ray number, side of patient, and initials all films., • Develops exposed x-ray film using processing methods., • Completes patient requisitions with technologist’s initials, date number, and size of films., • Assists with quality control procedures and documentation as delegated by Chief Mammography Technologist., • Assists in breast self-exam instruction and other patient education including pre and post procedure instructions., • Prepares cases to be imaged including chart and films., • Assists with compiling statistics for patient follow-ups, breast localizations, biopsies, and ultrasound examinations., • Documents procedures regarding quality control and assurance for mammography in compliance with ACR, MQSA, NJ State and FDA., • Documents pertinent patient information in the Breast Center chart., • Modifies and delivers care specific to patient needs including age, culture, language, and disabilities., • Communicates with patients, parents, and caregivers at appropriate developmental and educational levels., • Adheres to organizational competencies and standards of behavior.Job Requirements, • Minimum 2 years prior experience as a Licensed Mammography Technologist., • High school diploma or equivalent., • Graduate of an AMA approved School of Radiologic Technology., • Must have ARRT certification., • Must obtain mammography certification within the first three months of employment., • Must have active Diagnostic Radiography License.Unit Specific Information, • Works within the Breast Center performing mammography and related breast imaging procedures.

Job DescriptionDescription: AAF International is an Equal Opportunity Employer M/F/Disability/Veteran. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, sexual orientation, gender identity, national origin, citizenship, veteran status, uniform servicemember status, age, disability or any other legally recognized protected personal characteristics. Certification Tech to work at various customer sites throughout New Jersey and New York. This successful team player will perform HEPA filtration certification, service, and preventive maintenance in a wide variety of Cleanroom and containment applications. you mut be able to work in a team environment; keep neat and accurate records, willing to work in outdoor areas as well as a sterile environment, follow OSHA, FDA and other regulatory guidelines and assist in other duties and areas of maintenance as needed. Requirements: • Be familiar with all Certification test equipment and their proper use, • perform airflow readings and be proficient in the analysis of obtained data, • travel to customer sites to conduct HEPA filter testing and installations, • troubleshoot and diagnose problems in field testing situations, • prepare complete and organized reports, • routinely inspect HEPA filtered areas, • conduct periodic customer evaluation and service status on field HEPA filtered equipment, • communicate with client on their projects, • provide daily timesheets to certification coordinator, • have valid driver's license, • be able to pass an MVR

Job Description Unit Pack is a family-owned and operated company with over 50 years of experience in packaging liquids, creams, gels, serums, oils, and pastes in single-use packages catering to your packaging needs. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing your brand. At our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that your needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations. Job Summary: As a Machine Operator, you will be responsible for operating and maintaining the machines to ensure efficient production of high-quality goods. Your primary focus will be on inspecting packages, monitoring machine performance, and maintaining a clean and organized workstation. Attention to detail, physical strength, and technical skills are essential for this role. Requirements: ● The job requires the ability to lift up to thirty pounds without assistance. ● You should be able to stand for prolonged periods of time. ● Climbing tall equipment to replace parts is a frequent task, so it is essential to do so safely. ● You will be working in a loud production floor environment, and proper hearing protection is mandatory. ● You must have a keen eye for detail to continuously inspect and focus on small details of produced goods. ● Inspect 100% of packages during production, including checks on print quality, seams, welds, and fill volume. ● Maintain the correct position at all times while operating the machine. ● Keep the workstation clean and organized, properly arranging tool trays, scale tables, and roll tables. ● Keep the work station stocked with necessary supplies: alcohol, wipes, gloves… ● Assemble boxes and fill them with the correct number of packages while adhering to designated weight requirements. ● Replenish raw materials on printers and tube makers, while also disposing if waste properly ● Replace wear parts to maintain a high level of quality in production ● Line boxes with paper to check for leaks and perform leak tests on boxes containing paper. ● Clean the production line at required times following work instructions to prevent downtime, interruptions, and defective packages ● Identify and replace defective jaws on the machine. ● Empty the butt trim chip bucket and water collect bucket at the machine as needed. ● Perform visual inspection to ensure proper functioning of pumps and prevent air entrapment unless the order is complete. ● Clean pumps following standard operating procedures (SOPs) for pump cleaning at designated cleaning stations. ● Accurately complete all quality control paperwork, following instructions and performing necessary checks. ● Report any issues with paperwork to the quality control team promptly. ● Record all machine stoppages using the Down Time Log, communicating with mechanics to accurately document stations and actions performed. ● Complete all tasks outlined in the Machine Operators Work Instructions on a daily basis. ● Attend weekly Machine Operator meetings to stay updated on any changes or improvements. ● By diligently executing these responsibilities, you will contribute to the overall efficiency and productivity of the production process and ensure the delivery of high-quality goods to customers. *Please note that this job description is subject to change as needed based on the evolving requirements of the role and the production environment. Company DescriptionUnit Pack is a family-owned and operated company with over 60 years of experience in packaging liquids, creams, gels, serums, oils, and greases in single-use packages. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing brands. At our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that customer needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations.Unit Pack is a family-owned and operated company with over 60 years of experience in packaging liquids, creams, gels, serums, oils, and greases in single-use packages. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing brands.\r\n\r\nAt our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that customer needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations.

Elida Beauty is a Global Personal Care Business. We proudly support and nurture our portfolio of iconic brands globally. Our ambition is to remix classic beauty brands for a new generation, making them even bigger beauty hits than they were the first time around, to drive accelerated growth and value creation. Driven by creativity and agility, we unleash the true potential of beloved brands, ‘Re-Founding’ them using a start-up mentality that always ‘finds a way’. Elida Beauty is a part of the Yellow Wood Partners portfolio of companies, a private equity company that invests exclusively in the consumer industry. Position Summary The Formulation, Process and Claims Consultant will ensure flawless execution of new product innovations or enhancements, technical transfer of new products, and reformulations. This role requires expertise in liquid and cream formulations, process development, and claims substantiation. The consultant will partner closely with Packaging, R&D Operations, Supply Chain Marketing, and external suppliers. In addition to a strong understanding of the end-to-end process for finished goods production, this role calls for creativity and strong business acumen. Primary Responsibilities • Partner with Marketing and Packaging on developing new product innovations for 2026+ and work with external suppliers on the briefing and prototyping stages of the project., • Develop and execute the end-to-end product development operations via external suppliers and manufacturers to ensure high quality, reproducibility, and reliability for all categories withing the portfolio (i.e. lotions, creams, body washes, etc.)., • Identify data gaps and actions in existing product portfolio., • Ensure robust documentation of product formulation, process, and corresponding claims data., • Collaborate with Procurement in establishing raw material supplier strategic partnerships across different categories (i.e. critical raw materials, fragrances, etc.) to co-develop/tap into innovation based on supplier’s expertise., • Partner with Procurement, Operations, and Quality in supplier selection, qualification, and onboarding processes to ensure the availability of high-quality, cost-effective packaging materials and services., • Partner with procurement to secure project cost targets with raw material suppliers and external manufacturers., • Design, optimize, and implement manufacturing and filling processes for liquid and cream products in partnership with external suppliers., • Support the transfer of production to new external manufacturers., • Troubleshoot issues in production and scale-up processes., • Drive continuous improvement initiatives for efficiency and cost savings., • Track performance of manufacturing sites to anticipate and prevent non-conformances., • Maintain partnerships with external sites in collaboration with Quality & Regulatory teams., • Draft and execute peer-reviewed manuscripts and technical reports. Required Qualifications • 5-10 years of experience with BS or equivalent, 3-5 years with MS, preferably in consumer goods, cosmetics, or related field., • Strong understanding of formulation technology and chemical science for liquids and creams., • Knowledge of GxPs and FDA compliance requirements., • Excellent communication skills, both spoken and written., • Ability to partner effectively across diverse business partners and customers., • Entrepreneurial mindset; hands-on and collaborative approach., • Critical thinking and comprehensive business acumen., • Ability to travel internationally and domestically up to 30%. Preferred Qualifications • Experience with consumer products such as skin care, cleansers and sun care., • Experience in formulation, product, and process development under Cosmetic or Drug regulatory classifications., • Knowledge of process design options for liquids (batch, semi-continuous, continuous)., • Process development and scale-up experience., • Experience working with external manufacturing and technical project management., • Experience generating, reviewing and organizing claims data in partnership with CROs., • Hands-on experience with R&D formula and specification management systems., • Experience managing large data sets including structured and unstructured data. Personal Attributes • Positive and energetic individual with strong business acumen and urgency to achieve results., • Consumer-centric, creative, and design-oriented., • Inquisitive, with a history of seeking and implementing best practices., • Invokes trust, collaboration, shared accountability, and continuous improvement., • Knows what excellence looks like and how to achieve it., • Ability to develop and implement strategy with a high bias for execution., • Demonstrated track record of problem solving, priority setting, and action orientation. Diversity at Elida Beauty Diversity at Elida Beauty is about inclusion, embracing differences, creating possibilities, and growing together for better business performance. We embrace diversity in our workforce. This means giving full and fair consideration to all applicants and continuing development of all employees regardless of age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, marriage and civil partnership, and pregnancy and maternity.

Company Overview Our client is a U.S.-based leader in healthcare, consumer products, and regulated formulations, developing and distributing a diverse portfolio spanning infection prevention technologies, medical devices, over the counter (OTC) drugs, cosmetics, sanitizers, disinfectants, and specialty cleaning products. With multiple R&D and manufacturing sites across the United States, the organization is known for its commitment to innovation, scientific rigor, and product excellence. The team is expanding and seeking a seasoned expert to lead product safety, toxicology strategy, and regulatory safety governance across a broad and growing portfolio. Position Overview This person is responsible for developing, implementing, and overseeing the non-clinical safety strategy that supports new product development, regulatory submissions, and the maintenance of marketed products. This role will lead safety strategy across drugs, medical devices, cosmetics, sanitizers, disinfectants, and other regulated categories, ensuring scientific robustness, regulatory compliance, and on-time delivery of all safety-related documentation. The ideal candidate blends deep technical expertise, strong regulatory acumen, and hands-on experience with a leadership mindset. Key Responsibilities Safety & Toxicology Leadership • Lead the Product Safety & Toxicology function, guiding safety strategies across early innovation, development, and post-market., • Develop and execute non-clinical safety plans supporting regulatory submissions, including:, • Investigational New Drug (IND) / New Drug Application (NDA), • Medical Device 510(k) submissions, • Pesticide registrations under applicable federal frameworks, • Evaluate new ingredients, impurities, and inactive ingredients for safety qualification., • Oversee the design, monitoring, and interpretation of in vitro and in vivo studies., • Author and review non-clinical safety sections for:, • IND / NDA submissions, • 510(k) medical device filings, • Pesticide regulatory submissions, • Deliver toxicological risk assessments, safety clearances, and Consumer Product Safety Reviews (CPSR)., • Serve as the safety representative across R&D, Clinical, Manufacturing, Quality, and New Product Development., • Advise teams on safety concerns, study design, and risk mitigation., • Maintain and improve safety documentation, assessment templates, and internal SOPs., • Lead initiatives to enhance process efficiency, accuracy, and compliance. o Raw material qualification o SDS generation o Packaging, fragrance, and nonwoven safety reviews o Managing third-party safety and environmental certifications (e.g., Safer Choice, USDA Biobased, NEA, EWG) o Foster scientific excellence, knowledge-sharing, and cross-functional alignment. Performance Expectations • Deliver high-quality, accurate, regulatory-compliant safety outputs on schedule., • Demonstrate scientific judgment, ownership, and proactive problem-solving., • Influence decision-making across cross-functional teams without formal authority., • Contribute innovative solutions and lead continuous improvement initiatives. Qualifications Education • Bachelor’s degree in Life Sciences required., • Advanced degree (PhD, PharmD, MS) strongly preferred., • 8–10+ years in toxicology, product safety, or regulatory safety roles., • Experience with regulatory submissions:, • IND / NDA, • Medical Device 510(k), • Pesticide registrations, • Exceptional written and verbal communication., • Strong analytical, organizational, and leadership abilities., • Ability to manage multiple projects in fast-paced, matrixed environments., • High attention to detail with strong problem-solving skills., • Independent, decisive, and comfortable interfacing with stakeholders at all levels. Working Conditions Hybrid schedule: 4 days onsite / 1 day remote in New Jersey.