Trabajos fda en New York, New York - Page 2Crear alertas

Will practice GCP and FDA/HSS regulations and will comply with Columbia University and Hospital policies and procedures related to Clinical Research. The Multi-Center Trials (MCT) Clinical Research Coordinator II will play an integral role in the coordination and conduct of clinical trials involving

Ensure compliance of products and documentation with regulatory (FDA, State Health Departments, USDA), customer, and third-party standards. Health Savings Account option with quarterly employer contributions.

The Picker is responsible for the efficient movement, selection, loading of food products, accurate scanning, accurate transactions, timely documentation, and maintenance of the facility up to FDA standards.Repetitive lifting, visual identification, and an understanding of labeling practices are key

Supervises and coordinates the staff and activities of designated studies.Interprets protocols, makes recommendations for program enhancement initiatives and maintains industry, FDA, and granting agency relationships.Adheres to and assists in the training of research staff on Good Clinical Practice,

Job Title: Quality Specialist- II -Hybrid Job. Serve as the Quality Assurance Unit (QAU) in compliance with VICH GL9 (GCP), FDA 21 CFR Part 58, and EPA 40 CFR Part 160 (GLP). A thorough and expeditious audit process is necessary for meeting high-quality submission requirements.

Senior Account Executive - Enterprise Sales - Germany. Complement centralized marketing campaigns with own prospecting, develop relationships and alignment at multiple levels C level executive sponsors, influencers, and day-to-day users. FDA approvals executive appointments, press releases) for the

The Picker is responsible for the efficient movement, selection, loading of food products, accurate scanning, accurate transactions, timely documentation, and maintenance of the facility up to FDA standards.Repetitive lifting, visual identification, and an understanding of labeling practices are key

Job Description High end food food manufacturer in the Hunts Point Market is adding a new position to their quality assurance team. • Review ingredient lists, nutritional analysis, allergen statements, and marketing claims to ensure they meet FDA/USDA regulations and international standards., • Audit supplier specifications and documentation to verify ingredient integrity and adherence to food safety standards., • Develop and perform shelf-life studies to ensure product stability and regulatory requirements for code dating and oversee SQF, GMP and HACCP programs., • Maintain internal systems for tracking label approvals, revisions, and version control The successful candidate will • Be a seasoned compliance professional with meaningful experience in food & beverage marketing, • Strong knowledge of USDA & FDA labeling regulations and nutrition labeling requirements, • Ability to work with cross functional teams, • A strategic thinker with regulatory expertise, • Excellent written and verbal communicator Company DescriptionCivilized People is known throughout the industry for our honesty, integrity and straightforward nature. Our years of hands-on in-the-trenches industry experience has given us the tools necessary to be successful in search. Our consultants have over 50 years of hands on experience in the retail and hospitality industries. We have been working in these customer service-oriented industries for virtually our entire careers and have an understanding of the desires and motivations of hospitality and retail professionals. Matching the right people with the right opportunities is hard work. Each day we work diligently to balance the needs of our client organizations with the needs of our candidates and to respond to these needs quickly and effectively.Civilized People is known throughout the industry for our honesty, integrity and straightforward nature. Our years of hands-on in-the-trenches industry experience has given us the tools necessary to be successful in search.\r\n\r\nOur consultants have over 50 years of hands on experience in the retail and hospitality industries. We have been working in these customer service-oriented industries for virtually our entire careers and have an understanding of the desires and motivations of hospitality and retail professionals. \r\n\r\nMatching the right people with the right opportunities is hard work. Each day we work diligently to balance the needs of our client organizations with the needs of our candidates and to respond to these needs quickly and effectively.

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 DescriptionCustoms House Broker located in the JFK/ Five Towns area seeks the following candidates: Experienced entry writer with knowledge of HTS classification for FDA related merchandise in addition to knowledge of USDA/ Fish & Wildlife products. ISF Data entry clerk, duties include allocating all shipping documents, track & trace incoming ocean cargo and filing of ISF IMMEDIATE HIRE!!!!!

Job DescriptionAbout CookUnity: Food has lost its soul to modern convenience. And with it, it has lost the power to nourish, inspire, and connect us. So in 2018, CookUnity was founded as the first-of-its-kind platform that connects the world with the source of truly great food: chefs. Today, CookUnity delivers 50 million meals a year from the industry's best chefs to homes all over the country. Fresh. Ready-to-eat. And crafted with the passion that nourishes body and soul. Unwilling to stop there, CookUnity is expanding beyond delivery to become an ever-innovating marketplace focused on our singular mission: empower Chefs to nourish the world. If that mission has you hungry in more ways than one, you've found the right job posting. The Role: The Food Safety Specialist ensures a sustainable, safe, clean, and functional environment in the CookUnity Commissary. Responsibilities: • Monitor food production and ensure all Chefs are adhering to food safety regulations, • Perform critical checks including refrigeration, chemical concentration and and temperature checks, • Communicate kitchen rules to Chefs as needed- gloves, hairnets, proper hand washing, cleaning of equipment, sanitizing of prep stations, etc., • Ensures all items in coolers and freezers are appropriately labeled. (Labels must include Chef Name, Product Name and Date), • Daily facility compliance walks including corrective actions, • Work closely with other departments such as Kitchen Operations, Supply Chain and Maintenance to correct issues affecting food safety and quality., • Ensure the facility is always ready for inspection by local regulator or third party auditor, • Ensure all walk-in coolers and stand alone fridges remain closed and temperature is at 41 degrees or lower, • Perform weekly thermometer calibrations for Chefs and Food Safety team, • Collaborate with other members of Food Safety team in Chef and employee training on food safety and sanitation topics, • Perform facility and department audits, • Collect and provide data on cooler function and sanitary transport to operations and facilities teamsMinimum Requirements:, • Experience working in a high compliance food processing facility (USDA, FDA), • Positive and committed to doing the right thing, • Experience working with a team in a fast paced environment, • Good communication skills and ability to speak in a professional manner to a wide range of partners and stakeholders, • Ability to build relationships and explain food safety concepts in plain language, • Ability to work independently and complete assigned duties without direct supervision, • Proficiency G Suite/Google Workspace., • Team player with a positive, collaborative mindset, • Ability to work 30-40 hours per week., • Flexible availability for overnight shifts, such as 10:00 PM to 6:00 AM, • Bilingual English/Spanish required Benefits 🩺 Health Insurance coverage 🌅 401k Plan ⛱ Paid sick days 🌟 Awesome opportunity to join a company that is looking to change how we eat and how chefs work! Compensation All final pay rates will be determined by candidates experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.Pay Range for this position$21—$27 USD If you're interested in this role, please submit your application, and if we think you might be a fit, we'll get in touch with you. Thank you for your time! CookUnity is an Equal Opportunity Employer. We are dedicated to creating a community of inclusion and an environment free from discrimination or harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, citizenship status, protected veteran status, genetic information, or physical or mental disability. A quick note for all candidates We've recently seen an increase in recruitment scams across the industry, and we want to make sure you (and your data) stay safe while applying to CookUnity. We also want you to know that we take this seriously — sometimes, as part of our process, we may ask for a brief "proof of humanity" to confirm that we're connecting with a real person, not an impersonator. Here are a few tips to help you protect yourself and know what to expect from us: • Apply only through our official channels. All open roles are listed on our official careers page: careers.cookunity.com, • Our recruiters are real people — and easy to verify. You can always find them on LinkedIn with verified profiles. If you're unsure, feel free to reach out to us on our official LinkedIn Company Page., • We only communicate through official CookUnity channels. That means emails ending in @cookunity.com and interviews held through official company platforms (Google Meet or Zoom) — never WhatsApp, Telegram, or SMS.

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 DescriptionJob Title: QA Associate - Batch Record Review Job Description Perform detailed batch record review for manufacturing, packaging, and labeling operations to ensure accuracy, completeness, and compliance with cGMP requirements, including in a sterile manufacturing facility. Verify that all critical process steps, test results, deviations, and yields are properly documented. Identify documentation errors, inconsistencies, or missing information and coordinate corrections with Manufacturing, Quality Control, and other departments. Responsibilities • Review equipment cleaning logs, line clearance forms, and related production documents., • Support lot disposition activities by preparing QA documentation packets for final review., • Assist in investigating deviations, nonconformances, and CAPAs as needed., • Participate in internal audits and support external regulatory inspections., • Maintain QA documentation according to standard operating procedures., • Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or related discipline., • 1–3+ years of experience in pharmaceutical, biotech, or regulated manufacturing environments., • Strong understanding of cGMP, FDA regulations, and batch documentation requirements., • Excellent attention to detail and strong organizational skills., • Experience with SAP is a plus. The QA department is divided into two teams: QA Operations and QA Systems, with approximately 8 people across both teams. The QA Operations team handles batch record review, AQL, inspections, temperature checks, and label and vial review, while the QA Systems team manages document control, QMCS, calibration, change controls, deviations, investigations, and CAPAs. Employees may have responsibilities in both departments. The work schedule is Monday through Friday, from 8 am to 4:30 pm. Job Type & Location This is a Contract to Hire position based out of Port Washington, NY. Pay and Benefits The pay range for this position is $28.85 - $31.25/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Port Washington,NY. Application Deadline This position is anticipated to close on Feb 28, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job DescriptionCompany Description Eataly is the world’s largest artisanal Italian food and beverage marketplace! Eataly is not a chain; each Eataly is different, with its own character and own theme – but all with the same aim... for our guests to: • EAT authentic Italian food at our restaurants, cafés and to-go counters, • SHOP a selection of high-quality Italian, local and homemade products, • LEARN through our classes and our team’s product knowledgeJob Description The Area Health and Safety Manager oversees food safety, work safety, and sustainability compliance across an area of multiple Eataly stores. The Manager ensures that teams are fully versed on state and local rules and regulations as well as Eataly goals and that excellent safety standards are consistently met. Reports to the Senior Manager, Health & Safety North America • Partners with the Executive Chef, Facilities Manager, Human Resources, and the Store Director in each store to ensure proper food safety compliance, work safety, and sustainability measures, • Collaborates with Health & Safety North America team daily on company wide initiatives and troubleshooting, • Works directly with production employees to troubleshoot and solve food safety issues; implements corrective actions based on solid root cause analysis, • Conducts regular meetings (in-person, virtual, or via email communication) with members of each store’s leadership team for support and guidance related to food safety, • Conducts formal and informal audits of stores, requiring person to be based in a store and traveling to additional stores on a schedule determined between supervisor and incumbent. regular in-person visits to stores to conduct food safety audits of departments and provide follow-up to local store department managers, • Develops relationships with local health departments: keeps current on changes in regulations and standards, communicating updates to restaurants and providing training as needed; follows up on issues identified in health inspections to ensure they are remediated and tests for recurrence, • Clearly and regularly in communication with Senior Manager or other levels of leadership with updates, • Reviews and maintains the area stores’ food safety-related records, Emergency Action Plans, Waste Logs, and additional documents including but not limited to (e.g., receiving records, HACCP plan), • Provides guidance and direction as required by means of store openings, audits, inspections, training, team support, and consultation, • Ensures compliance with all applicable local and federal regulatory agencies (DOH, FDA, CFIA, OSHA, USDA, Port Authority, etc.), • Oversees training and development of store teams, directly and/or indirectly providing coaching, direction, and leadership support, • Assists in the development, implementation, and management of effective food safety and work safety programs, ensuring proper programs are in place to meet strategic goals as well as all applicable regulations, • Performs other duties as required or assignedQualifications Qualifications • Bachelor’s Degree in Management, Nutrition, Health and Safety, Environmental Health, or a related field preferred, • Serv Safe Manager Certificate or ability to obtain within first 30 days of employment, • NYC Food Protection Certificate preferred or ability to obtain within first 30 days of employment, • 4 + years of food safety management experience, • Restaurant or food retail experience, • Knowledge of OSHA , Federal, and local DOH regulations, • Proficient in Microsoft Office Suite, • Ability to work independently with minimal direct supervision; high level of self-motivation, • Outstanding analytical, organizational, and problem-solving skills, • Excellent communication, motivation, and team-building skills, • Ability to exert well-paced mobility for up to 8 hours, • Ability to travel as needed for store support across the region for up to two weeks at any time Additional Information Benefits and Perks • Medical, Dental, Vision Insurance, • Paid Time Off, • Paid Parental Leave, • 401k with company match, • Bonus program, • Free family meal daily, • Discounts at Eataly, • Classes on products and Italian cuisine, • Referral bonus program

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 The Quality Assurance Technician is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilon’s products in the Animal and Human Health industries. This position requires a strong attention to detail as the individual will be responsible for identifying deviations in product quality or safety and ensuring compliance with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP). Position is for 2nd shift. Responsibilities: • Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager., • Perform line clearance activities and in-process inspections., • Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below), • Transfer materials between facilities (see lifting requirements below), • Facility 1 of 2: 122 18th Street, Brooklyn, NY 11215, • Facility 2 of 2: 87 35th Street, Suite 603/604/6R, Brooklyn, NY 11232, • Operate testing equipment such as force testers, torque testers, and balances., • Report all deviations in product, components, raw materials, and equipment per their relevant procedures, • Perform document control activities, including but not limited to printing logbooks and batch records., • Transcribe data into digital systems for tracking Quality Metrics., • Batch record review & support routine batch disposition Requirements Education: High School Diploma or Equivalent (2- or 4-year degree in Engineering, Science, or Technology/Biotechnology preferred) • Required experience in GMP and FDA regulated environments (ISO 13485:2016 preferred), • Ability to be Gowning Qualified per Cresilon’s SOP., • 1 year experience in regulated industry highly desirable · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement The salary for this role is $25/Hour Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

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.

Job Description Location: Remote Job Description: The Project Manager is a proven leader in clinical program management in the clinical research industry, and manages, executes, and reports on clinical study operations. This position provides leadership and support to members of the multidisciplinary project team, internally and externally. Responsibilities encompass the overall management of a project including budgeting, timeline adherence, internal and external communications, and project deliverables. Under limited to no supervision, act as the liaison between the sponsor, team members, and sites while managing projects to ensure quality service. This position will be part of the Clinical Operations Team, which is responsible for planning, executing, managing, and closing projects associated with the company clinical study plans. Essential Duties and Responsibilities: • Assume primary accountability for assigned clinical research projects and ensure compliance with applicable regulations, guidelines, and corporate policies for study activities., • Manage and execute the overall project scope, budget, and timelines. Identify project success factors for analysis, reporting, and tracking., • Manage resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, and contractual agreements., • Lead the development of study specific protocols, consent forms, and other trial related materials as required., • Ensure the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies., • Participate in the review of clinical data for analysis., • Ensure that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs)., • Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated., • Plan for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device. Monitor adherence to project contract and budget., • Coordinate with clinical, marketing, and operations management to identify goals and scope of clinical study projects. Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed., • Support the management and oversight of clinical study related vendors. Review site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements., • Provide therapeutic training and guidance to clinical team., • Enhance department and organization reputation by participating in departmental or corporate initiatives., • Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations., • Attending off-site meetings and conferences, as needed., • Bachelor’s degree or equivalent education/degree in life science/healthcare is required accompanied by 5 years of working within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program., • CRO experience is highly desirable, multiple phases and therapeutic experience is preferred., • Experience qualifying & managing external vendors., • Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies., • Ability to facilitate a teamwork philosophy with a positive attitude., • Extensive organizing and coordinating skills, teaching and facilitation skills, ability to assess training needs and objectives., • Extensive experience overseeing and coordinating the work of others., • Ability to work effectively and efficiently handling multiple tasks simultaneously., • Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity., • Ability to manage multiple deadlines., • Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects., • Strong computer skills, including Microsoft Office.

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 QpHnpP1sVI

Job Description About Lantheus Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands. Summary of role We are seeking an experienced Associate Director Quality Control to lead analytical laboratory operations supporting pharmaceutical manufacturing and product development at our Evergreen Theragnostics site in Springfield, NJ. The ideal candidate is a proactive leader with strong technical expertise, comprehensive understanding of industry practices, regulatory requirements, and a commitment to safety, quality and continuous improvement. This position is based in New Jersey and requires a presence on-site, three days per week. This position is open to applicants authorized to work for any employer within the United States. Responsibilities Strategic Leadership & Operational Oversight • Develop and execute strategic plans for the QC function, leveraging expertise to drive decisions that align with business objectives., • Manage departmental goals to ensure reliable product supply, adherence to company policies, and successful project execution., • Ensure all aspects of laboratory operations are effectively managed, including training, scheduling, inventory, equipment maintenance/calibration, and safety., • Maintain validated methods and qualified equipment, ensuring all QC testing and data management activities comply with SOPs, cGMPs, and regulatory standards., • Ensure effective use of electronic systems such as ERP, QMS, LIMS, and lab equipment software., • Build and manage a high-performing team through effective staffing, training, performance reviews, and workload balancing., • Foster a culture of continuous improvement, compliance, and technical excellence., • Act as a liaison with other departments and management levels to support operational decisions and strategic planning., • Establish and interpret operating policies and procedures for the QC function., • Ensure inspection readiness and compliance with global regulatory requirements (e.g., FDA, USP/EP/JP)., • Oversee timely and effective use of QMS tools including training, investigations, deviations, CAPAs, SOP revisions, change controls, and protocols., • Serve as lead investigator, SOP owner, change control author, or protocol study lead as needed., • Promote and enforce safety protocols, ensuring proper use of protective equipment and safe handling of hazardous materials., • Proactively identify and address safety and environmental risks within the laboratory environment. Basic Qualifications • Requirements include a B.S. in relevant scientific/technical discipline, advanced degree or technological certificates preferred but not required., • 10 years’ experience of progressively more responsible laboratory management in a related scientific/technical discipline or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment, or equivalent., • Deep understanding of QC operations, regulatory requirements, and industry best practices with proven leadership in managing complex laboratory environments and cross-functional teams., • Prior direct experience engaging with health authorities is required., • Flexibility with scheduling requirements for staff and manage support to include evenings, weekends, shifts, and holiday coverage, including during adverse weather conditions. The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone’s health is in our hands Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until March 2, 2026. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at .

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 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 DescriptionAbout Sunrise Group Sunrise Group is building the future of sleep health by combining breakthrough technology with expert care. We started in 2015 with a straightforward idea: sleep diagnosis should happen in the comfort of your own home, not in a hospital. To make that possible, we created a first-of-its-kind chin sensor, carefully validated through clinical research, reviewed by leading sleep experts, and cleared by the FDA. Since then, Sunrise Group has grown from a single innovation into a complete sleep health company. We now design advanced diagnostic and treatment solutions, and we deliver care directly to patients through Dreem Health, our digital sleep clinic. By serving patients in all 50 states with reimbursed care, we are making sleep treatment more accessible, more personal, and much simpler than it has ever been. Your Opportunity The Senior Manager of Contracting & Credentialing is a strategic and operational leader responsible for overseeing provider credentialing, provider licensing, payer contracting, and network expansion across multiple states for a growing telehealth sleep medicine organization. This role requires deep expertise in multi-state credentialing, payer enrollment, government programs (Medicare/TriCare), and third-party vendor management, with a strong understanding of reimbursement and compliance. This role is critical to enabling scalable growth, payer access, and regulatory compliance in a complex, multi-state telehealth environment. The Senior Manager will directly influence provider onboarding speed, payer coverage, revenue integrity and long-term network strategy with direction from the Direction of Managed Care Contracting. The ideal candidate is CPC-certified, highly organized, data-driven, and experienced in scaling provider networks while maintaining compliance with federal, state, and payer requirements. What You'll Do Credentialing & Provider Enrollment • Lead end-to-end provider credentialing, provider licensing and recredentialing for MDs and NPs, and any additional allied clinicians across multiple states, • Oversee CAQH, PECOS, Medicare, and commercial payer enrollment, • Ensure compliance with state licensure, scope of practice, supervision, and collaborative practice requirements, • Maintain credentialing records, expiration tracking, and audit-ready documentation, • Lead payer contracting strategy across commercial, Medicare Advantage, and government payers with direction from Director of Managed Care Contracting, • Negotiate and evaluate fee schedules, reimbursement rates, and contract terms, • Support payer expansion strategy aligned with business growth, market demand, and clinical capabilities, • Coordinate contracting for multi-entity, multi-TIN structures, • Oversee Medicare enrollment and compliance (PECOS, reassignment, revalidation), • Support state-specific government program participation, • Ensure adherence to CMS, No Surprises Act, and payer regulatory requirements, • Manage relationships with credentialing and contracting vendors, • Define SLAs, workflows, and performance expectations, • Audit vendor work for accuracy, timeliness, and compliance, • Partner closely with Compliance, Legal, Finance, Product, Clinical Leadership and Sales/Marketing/Business Development, • Support product and dev teams with credentialing and payer data requirements (APIs, system builds), • Provide reporting and dashboards on credentialing status, payer growth, and risk areas, • Prepare materials for board, compliance committee, and executive review What You Bring, • CPC Certification (required), • 7+ years of experience in provider credentialing, payer contracting, or provider enrollment, • Proven experience with multi-state credentialing and telehealth operations, • Strong knowledge of Medicare/PECOS, commercial payers, and government programs, • Experience managing third-party credentialing and contracting vendors Familiarity with sleep medicine, DME, or specialty care preferred, • Strong understanding of provider reimbursement and fee schedules, • Exceptional organizational, communication, and stakeholder-management skillsWhat Makes You Stand Out, • Experience in a telehealth or virtual care environment, • Knowledge of AASM, ACHC, or similar accreditation standards, • Experience supporting API-driven or data-centralized credentialing systems, • Meaningful work that directly improves peoples' lives, • Be part of an international team across the US, France, Belgium, • Annual company offsite, • Comprehensive health benefits (medical, dental, vision), • FREE One Medical membership, • 401(k) with company match, • 20 days PTO + 10 paid holidays + 80 hours paid sick leave We hire humans, not bullet points. Don't meet every single qualification? That's okay. We care more about who you are than what's on your CV. We're looking for people who are curious, resourceful, and ready to roll up their sleeves — especially if you're excited about building something new in healthcare. So if you think you could make an impact here, reach out to us. Dreem Health / Sunrise is an Equal Opportunity Employer. We welcome people of all backgrounds and are committed to building a workplace where everyone feels included and respected. We do not tolerate discrimination or harassment of any kind.

Job Description The Continuous Improvement Manager is responsible for leading, developing, and executing strategies to drive operational excellence across the medical device manufacturing organization. This role champions Lean, Six Sigma, and problem‑solving methodologies to improve product quality, reduce waste, enhance cost efficiency, and ensure regulatory compliance. The Continuous Improvement Manager partners closely with Manufacturing, Quality, Engineering, Supply Chain, and Regulatory Affairs to standardize processes and cultivate a culture of continuous improvement. Key Responsibilities Continuous Improvement Leadership • Develop and implement sitewide continuous improvement strategies aligned with business goals., • Facilitate Kaizen events, value stream mapping, root cause analysis (RCA), and other improvement workshops., • Mentor and train employees at all levels in CI tools, Lean thinking, and structured problem-solving., • Analyze production and quality performance to identify opportunities for efficiency, cost reduction, and throughput improvements., • Drive initiatives using DMAIC, PDCA, 5S, standard work, and other Lean/Six Sigma methodologies., • Ensure improvement projects support and strengthen compliance with FDA regulations (21 CFR Part 820), ISO 13485, and internal QMS requirements., • Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation., • Plan, execute, and sustain medium‑to‑large scale CI projects, ensuring milestones are met., • Develop business cases, project charters, and ROI analyses to justify improvement initiatives., • Promote a culture of operational excellence and accountability throughout the organization., • Create and maintain training materials, SOPs, and standardized processes., • Bachelor’s degree in Engineering, Manufacturing, Operations, or related field., • 5+ years of experience in continuous improvement, operational excellence, or process engineering within a regulated manufacturing environment (medical device preferred)., • Strong working knowledge of Lean, Six Sigma, and structured problem-solving tools., • Experience working within FDA-regulated or ISO 13485 environments., • Demonstrated success leading CI projects and cross-functional teams., • Excellent analytical, communication, facilitation, and change‑management skills., • Familiarity with statistical software (Minitab, JMP, etc.)., • Experience with automation, digital manufacturing tools, or Industry 4.0 technologies.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job Description Job description Granulation Technology, Inc. is a leading pharmaceutical manufacturer specializing in high-quality OTC (over-the-counter) products. As a fast-growing, Indian-owned and majority women-owned company, we are committed to excellence, innovation, and customer satisfaction. Role Overview: We are seeking a results-driven Pharmaceutical OTC Sales Representative to expand our market presence, secure new accounts, and maintain strong relationships with key customers. This is an exciting opportunity for a sales professional with experience in the pharmaceutical OTC industry. Responsibilities: ✅ Identify and develop new sales opportunities within the OTC pharmaceutical market. ✅ Build and maintain relationships with distributors, retailers, and healthcare providers. ✅ Present and promote our OTC products to potential clients. ✅ Negotiate contracts, pricing, and supply agreements. ✅ Stay updated on industry trends, competitor activity, and market demands. ✅ Collaborate with internal teams (marketing, regulatory, and logistics) to ensure customer satisfaction. ✅ Meet or exceed sales targets and KPIs. Qualifications: Experience: 10+ years in OTC pharmaceutical sales. Skills: Strong negotiation, relationship-building, and communication skills. Knowledge: Familiarity with the OTC market, retail distribution, and pharmacy channels. Self-Motivated: Ability to work independently and drive results. Travel: Willingness to travel as needed for client meetings and industry events. Why Join Us? ✨ Opportunity to work with a growing pharmaceutical company. ✨ Competitive salary with uncapped commission potential. ✨ Flexible work environment with career growth opportunities. ✨ Be part of a dynamic, diverse, and innovative team. Company DescriptionGranulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.Granulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.

Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are hiring a highly experienced Quality Director to join our team. The Director of Quality provides enterprise‑level leadership for quality governance, compliance oversight, and risk management across clinical development and research activities. This role is accountable for ensuring that clinical programs, laboratory operations, and external partners operate in alignment with global regulatory expectations and internal quality standards. As a senior leader, the Director of Quality partners closely with executive and functional leadership to embed quality by design, maintain inspection readiness, and support company-wide development programs. • Lead and execute the organization’s clinical and research quality strategy, ensuring alignment with GCP, GLP, internal standards, and global regulatory requirements., • Serve as the senior authority for quality governance, compliance oversight, and inspection readiness across development programs., • Establish, maintain, and continuously improve the Quality Management System, including SOP governance, training, deviation management, and CAPA processes., • Design and oversee risk‑based audit programs and provide quality oversight of CROs, laboratories, and other external partners., • Ensure regulatory inspection readiness through strong documentation practices, data integrity controls, and TMF oversight., • Partner cross‑functionally to integrate quality into clinical development plans, protocols, and operational execution., • Lead quality risk assessments, track key quality metrics, and communicate risks and trends to executive leadership., • Build, mentor, and lead a high‑performing quality organization while fostering a culture of integrity and continuous improvement. Requirements • Advanced degree in a related technical field., • 10–25 years of progressive experience in quality leadership within the pharmaceutical or biotechnology industry., • Deep expertise in GCP and GLP regulations supporting clinical development and research., • Demonstrated success leading quality systems, audit programs, and inspection readiness initiatives., • Strong understanding of global regulatory frameworks (FDA, EMA, ICH, and related authorities)., • Proven ability to influence senior stakeholders and operate effectively in a matrixed environment., • Exposure to complex or specialized therapeutic areas., • Background in quality support for strategic partnerships, licensing transactions, or acquisitions., • Prior experience building or scaling quality organizations in growing or evolving companies., • Must be authorized to work in the U.S., • No C2C at this time. BenefitsDepending on the candidate’s experience, qualifications, and evolving business needs, this role may be structured as either a temporary or full-time position. Temporary roles include our medical and sick time benefits. Full-time positions are fully benefited in accordance with company offerings. Adhering to the requirements of New York's law on salary transparency, the salary bracket for this role is set between $125,000 - $155,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RT1

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 Our client in Fairfield, NJ is looking for an onsite, direct hire Manufacturing Industrial Engineer. Pay: $120k-$130k The ideal candidate will have an engineering background in mechanical engineering, industrial engineering, systems engineering, value engineering, or related engineering field with concentrated technical knowledge and previous experience in precision metals and plastics manufacturing and/or complex finished device assemblies. Responsibilities: • This role is fundamentally based on long-standing best practices in industrial engineering principles: identifying waste, defining value streams, productivity optimization, kanban setups, takt time studies, labor tracking, ergonomics, material flow, pFMEA, and similar Lean Six Sigma tools., • Support new business development with the purpose of generating accurate and detailed costing proposals that exceed customer expectations for quality, price, and delivery., • Bachelor's degree in Engineering (Mechanical, Industrial engineering, Systems engineering, Value engineering), • Minimum of 5 years of experience in value engineering, industrial engineering, manufacturing costing, or related role in the manufacturing industry, with specific experience utilizing industry 4.0 best practices and/or Lean, • Experience working for a Contract Manufacturer or OEM, • Strong engineering background with a solid understanding of manufacturing processes, materials, and equipment, • Ability to identify the best possible manufacturing processes, • Proficiency in using SolidWorks or equipment CAD/CAM software packages for estimating and DFM purposes, • Experience in product level design for manufacture (DFM), • Ability to collaborate across engineering Centers of Excellence for multi-plant vertically integrated proposals, • Excellent analytical and problem-solving skills, • Strong attention to detail and accuracy, • Effective communication and interpersonal skills, • Ability to work independently and as part of a cross-functional team, • Knowledge of industry standards and best practices in cost estimation

Job DescriptionABOUT PROJECT HEALTHY MINDS Project Healthy Minds is a mental health tech non-profit startup. We are pioneering a first-of-its-kind model: applying technology to address one of the biggest social issues of our time: the growing mental health crisis. We believe in a simple but profound idea: that it should be as easy to find mental health services as it is to book a flight or a restaurant reservation. That's why we're building the world’s first digital marketplace for finding mental health services that are right for you. To do that, we work with some of the most inspiring and influential leaders in America - business titans, tech entrepreneurs, clinicians and scientists, musicians, artists, athletes, media stars, policymakers, and more - because we believe that the world's most complex challenges require interdisciplinary teams and solutions. We are backed by a powerhouse of industry-leading Board of Directors and Advisory Council Members who are passionate, hands-on, and dive into the important work with us. Learn more at projecthealthyminds.com and @projecthealthyminds on social. ABOUT THE ROLE WHAT WE’RE LOOKING FOR:We’re hiring a Director of Live Programming who will oversee the production, programming, and overall attendee experience of the Project Healthy Minds World Mental Health Day festival and other brand-forward experiences. This leader should have four superpowers: • An extraordinary level of creativity and experience conceptualizing and producing outside-the-box, elevated events.• The production chops to make a Coachella production manager blush – someone who intuitively understands production specs and labor needs, has a deep network of vendor relationships and knows how to negotiate and manage vendors, knows all of the different shapes of venue deals and just as importantly, knows how to work with venues, and has the leadership qualities to lead a multi-stakeholder process for signature events and ensure the production of our events is world-class.• You live for producing one-of-a-kind, consumer-oriented, brand-forward experiences – from pop-ups to festivals and everything in between. You’d say you could have produced Spotify House at Ole Red in your sleep. • Exquisite taste and editorial brilliance to curate the right topics, speakers, and participants to ensure Project Healthy Minds events are some of the most intellectually interesting events around. This role will report into the VP of Development, will work very closely with the Founder & CEO, and will serve as a leader working cross-functionally with other members of the Development and Creative teams to conceive and execute groundbreaking events. HOW YOU’LL CONTRIBUTE:• Set the strategic vision and roadmap for the Project Healthy Minds World Mental Health Day Festival – the world’s first and largest – and other brand-forward experiences. • Lead the strategy for the Project Healthy Minds World Mental Health Day Festival – setting the programming, editorial, and talent vision, shaping the creative direction (with the Head of Creative), creating the production and staffing plans, etc. • Drive the execution of all festival production elements end-to-end in a hands-on manner – providing strong day-to-day leadership to all internal stakeholders, external vendors, and venue partners. • Lead all vendor and venue relations – from sourcing to negotiation to management to reporting.• Quarterback the process for securing talent for the festival and other brand-forward experiences – working in close partnership with the CEO, the VP of Development, Board of Directors, internal staff, and other key VIP partners/friends to Project Healthy Minds.• Create detailed end-to-end planning timelines for events and run the process to ensure best-in-class execution across the team.• Own the P&L for all events.• Oversee the creation of all event materials (e.g. digital experiences, printed materials at the event, etc.) – working in close partnership with the Creative and Development teams.• Ensure a world-class guest experience, thoughtfully considering the end-to-end user journey across every Project Healthy Minds touchpoint (pre-event, day-of, post-event).• Partner with the rest of the development staff to create thoughtfully curated invite lists and initiation strategies.• Manage partners and stakeholders.• Provide robust reporting to various stakeholders throughout the event planning and recap cycle. ABOUT YOU OUR IDEAL CANDIDATE IS:• A true event production pro – you have a proven track record with all aspects of events – from conceptualizing the programming structure and flow to setting timelines and driving planning processes to coordinating all production aspects (audio, video, labor, staging, catering, etc.) to leading the negotiation and management of labor/production needs to sourcing and managing vendors to creating detailed run-of-shows and so much more.• Detail-oriented and the most organized person in the room – you love developing effective systems. You are a meticulous planner and can ensure that all the moving parts of an event are clear and categorized. You keep the trains on the track and ensure all stakeholders meet deadlines.• Creative and seeking to establish a new standard for experiential – you have your pulse on what’s happening across the events landscape: fashion events, editorially-driven events produced by major media companies, music festivals, elevated VIP corporate client events, etc. You want to create cutting-edge experiences that everyone else can’t stop talking about. You have extensive experience working on events at media companies and/or on large-scale cultural events (think SXSW, Atlantic Festival, New York Festival, WSJ Future of Everything Festival, NYTimes Live, Coachella, Burning Man, or Cannes Film Festival).• A leader who enjoys building something new – you thrive in a fast-paced environment and identify as a multitasker that can perform under pressure. You enjoy leading cross-functional teams and being the leader that everyone looks to for vision, decisions, and timely feedback. You respond skillfully to rapidly changing priorities and are excited by the prospect of every day being different with new problems to solve. You are willing to travel for this role if needed.• A strong communicator – you have exceptional oral and written communication skills with an ability to engage and inspire a wide range of audiences and a diverse team of stakeholders. • Experienced – Bachelor’s degree and 15-20+ years of experience running events with proven success, ideally in the nonprofit space. WHAT WE OFFER

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: Our Senior Director, HCP Marketing will lead the development and execution of comprehensive healthcare professional engagement strategies to drive awareness, education, and adoption of COMP360. This role will be responsible for creating targeted HCP marketing campaigns, building strategic relationships with key opinion leaders and prescriber segments, and developing evidence-based educational initiatives that support launch readiness and commercial success. Location: Hybrid in our New York City office or remote on the east coast in the United States. Reports to: Chief Commercial Officer. Roles and responsibilities (Include but are not limited to): HCP and Consumer Strategy and Targeting • Develop and execute targeted HCP and consumer marketing strategies aligned with brand positioning and commercial objectives, • Lead HCP segmentation, targeting, and prioritization efforts in collaboration with Sales and Market Access teams, • Design engagement pathways optimized for different HCP personas including psychiatrists, primary care physicians, and institutional prescribers, • Design engagement pathways optimized for consumers and caregivers, • Create compelling, compliant educational content and promotional materials for HCP audiences that translate clinical data into practical insights, • Collaborate with Medical Affairs on KOL engagement strategy, advisory boards, and scientific communications to build clinical credibility, • Develop congress strategies, medical education programs, and peer-to-peer learning initiatives, • Lead omnichannel marketing strategy across digital, in-person, and virtual touchpoints to deliver personalized HCP experiences, • Drive digital marketing initiatives including HCP portals, email campaigns, social media engagement, and webinars, • Partner with Sales on field enablement, ensuring representatives have compelling messaging and materials for HCP interactions, • Build and lead a full cross‑functional marketing team, overseeing PME, Consumer, and Digital Marketing to drive cohesive strategy and execution, • Collaborate closely with Market Access to align HCP messaging with payer and reimbursement strategies, • Partner with Site of Care Marketing to ensure coordinated patient-provider messaging and journey optimization, • Work with Regulatory and Legal to ensure all HCP-facing materials meet compliance requirements, • 10+ years pharma/biotech marketing experience with demonstrated expertise in HCP engagement; CNS/psychiatry experience strongly preferred. Launch experience an asset, • Proven track record developing and executing successful HCP marketing strategies for specialty therapeutics or novel mechanism launches, • Deep understanding of HCP prescribing behaviors, clinical decision-making, and healthcare professional networks, • Bachelor's degree in life sciences, marketing, or related field; advanced degree or MBA preferred, • Strong expertise in omnichannel marketing, digital engagement platforms, and medical marketing in regulated environments, • Excellent scientific acumen with ability to translate complex clinical data into compelling HCP messaging, • Experience collaborating with Medical Affairs, Sales, and Market Access in launch environments, • Outstanding communication, stakeholder management, and cross-functional influence capabilities Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$250,000—$330,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job DescriptionAbout the job This role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities. Key Responsibilities: Primary Responsibilities • Assist in the preparation, formatting, and collection of regulatory submissions, • Ensure the maintenance of regulatory files, declarations of conformity, and device listings/registrations are accurate and complete., • Oversee inquiries into regulatory agency requests for additional information for document submission., • Support U.S. and EU market approval processes and ensure compliance with regulatory standards, • Support post-market submissions (progress reports, annual reports, etc.), • Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers., • Communicate with distributors in response to requests for information, regulatory inquiries or in support of regulatory filings.Compliance & Quality System Support, • Partner with Quality Assurance to ensure continued compliance with applicable regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745., • Support in audits (internal and external) in document preparation as needed., • Support document control and recordkeeping to ensure regulatory documentation integrity and traceability., • Assist in preparing regulatory applications that are compliant with applicable regulatory requirements to achieve business objectives.Cross-Functional Collaboration, • Partner with Engineering and Clinical teams to gather information needed for submissions and documentation., • Assist in preparing summaries, tracking deliverables, and ensuring timely submission of regulatory documents., • Support training and awareness initiatives related to regulatory compliance., • Interpret new or existing regulations and ensure business practices align with compliance requirements., • Create documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance., • Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to other teams/departments and executive leadership., • Establish and maintain regulatory information systems., • Contribute in continuous improvement initiatives and process optimization within Regulatory Affairs.Qualifications:, • Bachelor's degree in biomedical, RA/QA or related scientific area for medical device industry (RAC certification preferred)., • Master’s degree in related field can count towards 1 year of relevant experience., • 3-5 years of experience in a regulated FDA environment (medical devices or combination products strongly preferred)., • Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus). Strong knowledge in regulatory strategy and approval approaches., • Working knowledge of FDA, EU MDR, or ISO regulatory environments preferred., • Audit experience as a contributor is preferred., • Ability to efficiently navigate through the regulatory process either individually or in a team setting ensuring a project’s success., • Strong organizational, communication (verbal and written), and planning skills., • Ability to interact cross functionally across multiple departments with various levels of the organization., • Detail oriented, practical and proactive problem solver., • Proficiency with PC systems and office applications., • Solid understanding of scientific principles applied to regulatory affairs., • Understanding of regulatory and business needs with ability to engage cross functional team members.Salary range is $75,000- $85,000/annual USD An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits. We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind 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 and local laws. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email . Powered by JazzHR KfrVHAUAmF

Job DescriptionJob Title: Lead Quality Assurance TechnicianJob Description As a Lead Quality Assurance Technician, you will perform in-process and finished product inspections across manufacturing lines to ensure compliance with cGMP, SOPs, WIs, and product specifications. You will verify line clearance and readiness of production areas prior to use, monitor, sample, and test materials and finished goods, determine their disposition, and ensure appropriate documentation and labeling. Responsibilities • Execute rework protocols and support disposition activities as required., • Initiate and manage LIMS samples and documentation, and identify, document, and communicate non-conforming material in accordance with hold procedures., • Collect required product, reserve, and customer samples per manufacturing specifications., • Provide day-to-day coordination and guidance to QA Inspectors during the shift, including assigning and balancing workload as needed., • Perform inspection, documentation, or system-entry activities during high-volume periods or when coverage is needed., • Review QA documentation for completeness and accuracy prior to submission to the QA Release team., • Participate in production and quality meetings, including daily coordination meetings and Gemba walks., • Provide coaching and instruction to QA Inspectors to support consistent execution of quality procedures and documentation practices., • Support continuous improvement initiatives and promote a strong quality culture across the manufacturing floor., • Support QA operational activities including inspection tracking tools, logbooks, sample coordination, production order support, and other quality documentation and administrative tasks required to maintain inspection readiness and compliance., • Provide support for validation and trial activities across the manufacturing floor., • Lead training and onboarding efforts for new hires to ensure successful integration, competency development, and adherence to quality and compliance standards.Essential Skills, • 5+ years of quality experience in a regulated environment., • Proficiency in quality assurance, GMP, FDA regulations, and quality assurance testing., • Experience with inspection, batch records, CAPA, investigation, and analysis., • Associates Degree or equivalent relevant experience., • Proficiency in Microsoft Office Suite.Additional Skills & Qualifications, • Proven ability to communicate and collaborate with cross-functional stakeholders at all organizational levels, including senior management. 5% Target Bonus annually Medical, Dental, Vision, 401k match, etc. Holiday/Vacation/Sick Workplace Type This is a fully onsite position in Orangeburg,NY. Application Deadline This position is anticipated to close on Mar 3, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job DescriptionJob Title: GCP Auditor/Senior Auditor, Quality AssuranceJob Description This position focuses on ensuring GXP compliance with regulatory authorities, driving and implementing compliance directives, and supporting quality management systems to minimize risks in a regulated pharmaceutical environment. The role involves conducting and participating in all GXP QA audit programs, including internal and external audits, and providing support to the GXP QA Director across clinical operations, non-clinical, and manufacturing sectors. 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 subject matter experts 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 regulations, 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.Essential Skills, • 5+ years of pharmaceutical experience., • Bachelor's degree in scientific, healthcare, or related discipline., • Extensive 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.Additional Skills & Qualifications, • Sponsor experience, not only CRO experience., • 2 years of experience with GCP, TMF audits, system audits, inspection readiness, and CRO audits., • 2 years of experience in independent auditing. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Paramus,NJ. Application Deadline This position is anticipated to close on Feb 27, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description About Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking an experienced IRB Coordinator Consultant to join the Vitalief team as a contractor. In this role, you will support a leading hospital research center in Livingston, NJ, administering and overseeing Institutional Review Board (IRB) activities to ensure compliance with federal, state, and institutional regulations governing human subjects research. This role supports investigators, staff, and IRB members in the preparation, review, and approval of research protocols, while also assisting with Nussbaum grant activities. Engagement Details • Work Hours: 40 hours per week (8am to 4pm M-F), • Work Location: 100% on-site in Livingston, NJ., • Contract Duration: 6 months (possible extension), • Pay Rate: Market competitive (depends on experience level) Responsibilities:, • Under the direction of the Director of Graduate Medical Education and Clinical Research, coordinate and manage all IRB activities, meetings, and communications., • Review protocol submissions for completeness and accuracy; recommend appropriate level of review., • Draft and issue correspondence reflecting IRB deliberations and decisions., • Provide regulatory and methodological guidance to investigators, staff, students, and IRB members., • Maintain compliance with OHRP, FDA, ICH/GCP, and institutional regulations., • Manage IRB databases, tracking systems, and protocol documentation., • Assist with emergency use protocols and special meetings as needed., • Schedule and support Institutional Research Committee meetings, prepare agendas/minutes, and follow up on action items., • Collaborate with other system IRB Coordinators and departmental staff., • Bachelor’s degree in a scientific or health-related field required; Master’s degree preferred., • Three (3) years of experience in clinical research and research administration, including two (2) years of IRB operations experience., • Strong understanding of IRB regulations, ethical research standards, and ICH/GCP guidelines., • Excellent written and verbal communication skills., • Ability to demonstrate professionalism, clear communication, and respect in all interactions., • Passionate in supporting teamwork and collaborative problem-solving., • Apply continuous quality improvement principles to research operations., • Work independently with accountability, sound judgment, and openness to feedback., • Strong organizational and time management abilities; must be self-motivated and able to multi-task on a variety of projects., • Detail-oriented with strong organizational and follow-up skills., • Proficiency with Microsoft Office (Word, Excel, PowerPoint); database management experience preferred., • Certified IRB Professional (CIP®) is a plus., • Knowledge of medical terminology preferred. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR lfKp3BPFdR

Job Description Job Title: Quality Improvement Compliance Monitor Grade: 28 Salary: $109,145 - $117,588 The Research Foundation for Mental Hygiene is seeking a qualified candidate to fill a full-time Quality Improvement Compliance Monitor position. Reporting to the QIE Director and part of the greater HRPP, the incumbent will conduct site initiation visits and post-approval monitoring reviews of human subject research projects to ensure compliance with federal regulations and guidelines and NYSPI policies. Reviews often focus on, but are not limited to, review of recruitment practices, potential participant screening, adherence to eligibility criteria and the protocol, informed consent procedures, participant safety, document storage, and confidentiality of data. Note: This is a hybrid role with 50% on-site requirement Duties and Responsibilities: • Conducting for-cause audits authorized by the IRB or institutional official., • Writing reports and communicating findings with investigators, compliance committees, and appropriate parties., • Conducting education and training throughout the monitoring process with the ability to recommend further training to the human research education committee., • Providing regulatory guidance to the NYSPI research community. Assisting with site or study-specific research self-assessments., • Bachelor's Degree, • Previous experience as a member of a research team (i.e., study coordinator/research assistant), • Thorough knowledge of state and federal codes (Revised Common Rule, FDA, etc.) regarding research., • Considerable knowledge of Good Clinical Practice (GCP), • Certification as a Clinical Research Associate (CCRA) or SOCRA Certified Clinical Research Professional (CCRP), • Advanced computer/technical skills, • Strong organizational skills To Apply: Submit an application through our website at . Please note only applications submitted through our website will be considered. The Mission of the Research Foundation for Mental Hygiene, Inc. (RFMH) is to promote the mental health of all New Yorkers, with a focus on providing hope and supporting recovery for adults with serious mental illness and children with serious emotional disturbances. Applicants with lived mental health experience are encouraged to apply. RFMH is deeply committed to supporting underserved individuals, organizations, and communities. To this end, RFMH is focused on implementing activities and initiatives to reduce disparities in access, quality, and treatment outcomes for underserved populations. A critical component of these efforts is ensuring that RFMH is a diverse and inclusive workplace where all employees' unique attributes and skills are valued and utilized to support the mission of the Agency. RFMH is an equal opportunity/affirmative action employer. The Research Foundation is a private not-for-profit corporation and is not an agency or instrumentality of the State of New York. Employees of the Research Foundation are not state employees, do not participate in any state retirement system, and do not receive state fringe benefits. Excellent Benefits Package. Affirmative Action/Equal Opportunity Employer - Disabled/Veteran, 41 CFR 60-741.5(a) and 41 CFR 60-300.5(a) compliant. Job Posted by ApplicantPro

Job Description Job Title: Clinical Research Nurse Job Description The primary purpose of the Clinical Research Nurse is to ensure the successful, patient-oriented, safe, and effective conduct of clinical trials. This role involves assisting investigators in preparing and implementing new clinical trials, screening and enrolling study participants, and providing protocol-related clinical management to those participants while on study. The Clinical Research Nurse serves as a resource to faculty and staff on available protocols and general research topics such as FDA, IRB, and GCP regulations. Responsibilities • Collaborate with the Protocol Activation office to initiate and activate new clinical trial protocols., • Prepare and review study tools such as study binders, medication diaries, eligibility checklists, and flow sheets., • Verify Scientific Review Board, Institutional Review Board, data collection plans, and finance/contract approvals prior to study activation., • Review protocol and collect multidisciplinary logistical, educational, and financial feedback to identify potential obstacles to safe, effective study conduct., • Perform protocol-related nursing education to other disciplines to facilitate safe, effective care of enrolled patients., • Collaborate with the clinical research team to ensure timely prescreening of potential subjects and active cancer patients for clinical trials., • Review patient charts and medical history to confirm protocol eligibility and obtain source documents as needed., • Obtain informed consent for both therapeutic and non-therapeutic studies in accordance with IRB, GCP, and institutional policies., • Serve as a link between patients and all other members of the research team, addressing challenges with protocol completion and adherence., • Ensure protocol-specific orders are executed accurately, coordinating continuity of protocol-specified procedures between disciplines/sites of care., • Manage patient reimbursement while on clinical trial and deliver high-quality, compassionate oncology nursing care., • Collaborate with medical system staff to ensure coordinated and timely services for patients., • Grade adverse events using protocol-referenced NCI common toxicity criteria, provide informal teaching/coaching to clinicians, and complete SAE forms., • Assist in monitoring visits, audits, and providing responses to sponsor's queries., • Experience and comfortability communicating with patients., • Clinical research coordinator experience (1-3 years)., • Proficiency in computerized systems (e.g., Word, Excel)., • Excellent communication and interpersonal skills., • Detail-oriented with excellent organizational skills., • Graduate of an accredited school of nursing with a license to practice in the State of New Jersey., • Bachelor’s Degree in Nursing preferred., • One year of oncology experience required; three to five years of oncology research experience preferred., • Active Basic Life Support (BLS) certification., • Oncology Nursing Society (ONS) certification as an Oncology Certified Nurse (OCN) or Advanced Oncology Certified Nurse (AOCN) preferred. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Newark,NJ. Application Deadline This position is anticipated to close on Mar 4, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands. Summary of role The Radiopharmaceutical Clinical Applications Associate Director will be responsible for leading the clinical application efforts regionally for our radiopharmaceutical products. This role involves building and maintaining relationships with Key Opinion Leaders (KOLs) and Healthcare Providers (HCPs), providing advanced clinical and technical expertise, and ensuring the optimal use of our products in the clinical setting. The position will also support field research initiatives, provide educational training, and ensure compliance with industry regulations and company policies. This is a remote position open to applicants authorized to work for any employer within the United States. The territory includes MA, NY City, CT, RI, NH, ME, VT. Responsibilities • Identify, develop, and engage in long-term relationships with Key Opinion Leaders (KOLs) and Healthcare Providers (HCPs) in the assigned territory, including Nuclear Medicine Physicians, Radiologists, Radiation Oncologists, Technologists, Safety Officers, Health Physicists, Nursing Staff, and Advanced Practice HCPs at imaging facilities and medical centers., • Provide training to imaging/treatment centers on handling, administration, and radiation safety of current products, including initial and re-training sessions., • Educate on-site preparation and infusion processes for products, including radiopharmaceutical licensing, supporting approved imaging/therapies, and clinical trials., • Educate the HCP community to ensure they have the proper knowledge and technical expertise to use Lantheus products safely and effectively., • Utilize clinical and technical expertise to institutional workflows, regional diagnostic imaging patterns, treatment guidelines, and therapeutic advances in oncology and molecular imaging. Gather insights into the needs and interests of healthcare providers and the medical needs of patients with a focus on Lantheus approved and investigational agents., • Maintain thorough and up-to-date knowledge of imaging techniques, clinical information, and product data in the diagnostic and therapeutic radiopharmaceutical field., • Respond appropriately and document accurate scientific data in response to unsolicited questions from customers about approved and investigational products., • Support Lantheus Field Research Initiatives, including Investigator Sponsored Trials (ISTs), the Image Library, and Clinical Trials aligned with the Lantheus pipeline., • Attend national congresses and meetings, providing medical and scientific booth support as requested, in compliance with industry regulations., • Fully understand and comply with all Lantheus SOPs, working procedures, and corporate requirements., • Minimum Bachelor’s Degree Required, • 4+ years Nuclear Medicine Technologist, Clinical Application Specialist, or similar/relevant experience., • 2+ years Clinical experience in oncology, urology, neurology or radiopharmaceuticals/medical imaging, • Exceptional communicator and presenter with proven oral and written communications skills., • Advanced understanding of current and emerging trends in the field of Nuclear Medicine, radiopharmaceuticals, and diagnostic imaging., • Proficient at translating and communicating approved scientific or clinical data into high quality medical information appropriate to the audiences engaged., • Demonstrated success working in a team environment, communicating clearly and effectively with management, peers, and all cross-functional teams., • Highly motivated to achieve optimal results with a demonstrated record of career growth and achievement., • Advanced Word, PowerPoint, and Excel skills The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone’s health is in our hands Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until February 28, 2026. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at .

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Senior Manager, Clinical Quality is responsible for developing and implementing a risk-based GCP (Good Clinical Practice) audit program. This includes planning and conducting audits, coordinating the activities of independent QA auditors, and supporting regulatory inspection readiness activities and regulatory inspections by EMA, FDA and other competent authorities. The role contributes to quality risk management and continuous improvement across clinical trials and related processes. Location: Remote on the East Coast, USA or hybrid working in our NYC office. Reports to: Director, Clinical Quality. Responsibilities (include but are not limited to): • Provision of GCP QA advice and support to clinical project teams and cross-functional departments to help ensure compliance with applicable regulations and internal quality standards, • May act on behalf of the Director, Clinical QA, to provide leadership support and ensure continuity of QA oversight and decision-making, • Manage GCP audits of sites, documents, databases, vendors, or internal systems in compliance with GCP and Compass quality standards, • Coordinate activities of external auditors, during the preparation, conduct and reporting of GCP audits, • Support, and conduct when required, risk-based audits of clinical trial sites, both internally and those managed by CROs (Contract Research Organizations), vendors and internal systems ensuring adherence to GCP guidelines, protocols, and regulatory standards, • Support the preparation of comprehensive audit reports, identifying potential issues and recommending corrective actions for internal teams and collaborating with CROs to implement necessary changes, • Work closely with internal teams to ensure alignment with GCP expectations to address findings and action items from audits, • When required, lead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness, • Proactively assess compliance issues and risks; serve as the expert GCP consultant for issue management & issue escalation, • Support partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes, • Support the management of GCP inspections within Compass and at vendors/partners of Compass studies and/or processes, as required, • Liaise with regulatory agencies (e.g., FDA, EMA) regarding GCP compliance matters, • Stay up-to-date on evolving GCP regulations and best practices in clinical trial audit methodology, • Participate in the development and implementation of training programs for clinical trial staff, both internal and at CRO partners, on GCP and regulatory compliance, • Degree in a life science field or a related clinical research area (preferred), • GCP QA professional with broad drug experience which spans all clinical phases (Phase I to IV), • Extensive experience in GCP auditing and clinical trial operations, • In-depth knowledge of GCP guidelines (ICH-GCP) and regulatory requirements for clinical trials, • Strong understanding of clinical trial design, conduct, and data management, • Excellent leadership, communication, and interpersonal skills, • Strong analytical and problem-solving skills, • Ability to work independently and as part of a team, • Excellent project management skills Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Welcome! Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions and symptoms caused by excess neural excitability. Ovid is advancing a pipeline of novel targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. It is with curiosity, courage, and tenacity that, together, we work for meaningful change in the lives of patients and their families. With this sense of purpose and urgency we challenge the conventional and embrace the wisdom and thought that comes from diverse backgrounds and perspectives. Importantly, we understand the commitment we make to our patients, our broad community and to each other is based on the humanity that we share. The Role On Our Team We are seeking an experienced Clinical Operations professional in New York City, Philadelphia, or Boston area for our trials spanning early to late-stage clinical development. Your role will be responsible for overseeing and managing all aspects of clinical operations for a high priority program. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders working cross functionally with Clinical Development, Regulatory, Non Clinical and other internal functions to develop operationally feasible and clear protocol concepts and final protocols, and will independently oversee one or more clinical studies by establishing the operational strategy and securing excellence in execution through external partners to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III). This role will be a leader in the organization who knows how to manage a team internally, at our clinical sites and with our vendors. Reporting to the Sr Vice President, this is a highly visible and team-facing role. The role is a hybrid of office visits in NYC, working from home, and traveling to our sites and for business meetings. Key Responsibilities and Impact • Manage interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders and effectively interact with scientists and managers within and outside Clinical Research Organization (CRO), vendors, and partners. Have strong outsourcing experience, • Provide program-level sponsor’s operational oversight of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget, • Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors, • May also be responsible for contributing to a clinical development plan within a program moving into a new or subdivision of a current indication, • Organize and lead study specific meetings, • Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, robust, data monitoring plans, and other study documents, • Develop operational strategy along with CRO/vendors aligned with the program strategy and incorporating local and country-level input, • Lead and oversee the strategic planning, implementation and execution of clinical trials across key programs in accordance with project timelines, budget, and quality standards, • Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies, • Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones, • Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program, • Serve as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards, • Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct, • Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity, • 10+ years of clinical research / project management experience preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline, and budget expectations., • Detailed understanding and experience in all aspects of clinical protocol development, implementation, regulatory submissions, and overall drug development, • Ability to establish operational plans and support the CRO/vendor in the execution of the plans., • Prior investigator site and/or monitoring experience is advantageous, • Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the development of study designs is desirable., • Adaptability, flexibility, independence, and resourcefulness to roll-up-sleeves and multi-task so to thrive in a small company, fast-paced environment, • Marked proficiency in clinical and/or medical writing, • Broad experience in early-stage and late-stage development programs, • Demonstrated experience working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, • Extensive knowledge of regulatory guidelines and experience with worldwide regulatory agencies in therapeutic product development; global experience highly preferred, • Outstanding presentation, written and oral skills are required. A clear communicator who can influence effectively both internally and externally, • Bring a history of great collaboration and teamwork with the ability to motivate and influence others; have a reputation for successful partnering with internal and external stakeholders, • Have the ability and the drive to succeed in a small biotech organization. Interest to grow in the function to advance new technologies in new therapies. Must be self-motivated, proactive, work well under pressure and deadlines, and thrive in a small “all hands-on deck” environment, • Solution-oriented thinker who possesses a “can do” attitude with a strong sense of urgency, • Create a balance of analytical and methodical problem solving with creative and flexible solutions Ovid operates in a hybrid-work model. Candidates applying must be willing and able to be in the NYC office in coordination with their manager's expectations, as well as department and business needs. The base salary range for this position is $200,00-270,000. The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, skills, level offered, and performance expectations. Powered by JazzHR lJ9lJ1vhhf

Job DescriptionAbout CookUnity: Food has lost its soul to modern convenience. And with it, it has lost the power to nourish, inspire, and connect us. So in 2018, CookUnity was founded as the first-of-its-kind platform that connects the world with the source of truly great food: chefs. Today, CookUnity delivers 50 million meals a year from the industry's best chefs to homes all over the country. Fresh. Ready-to-eat. And crafted with the passion that nourishes body and soul. Unwilling to stop there, CookUnity is expanding beyond delivery to become an ever-innovating marketplace focused on our singular mission: empower Chefs to nourish the world. If that mission has you hungry in more ways than one, you've found the right job posting. The Role CookUnity is seeking an experienced and highly motivated Senior Manager, Food Safety to lead and scale food safety excellence across our NYC operations. This role is central to enabling CookUnity's rapid growth and marketplace expansion by building robust, data-driven food safety systems that protect customers, strengthen brand trust, and support operational innovation. Reporting into senior Quality & Food Safety leadership, this role partners closely with Operations, Culinary, Supply Chain, and Regulatory teams to embed preventive controls, regulatory readiness, and continuous improvement into daily execution. The ideal candidate is both strategic and hands-on—equally comfortable setting enterprise standards and working directly on the production floor. Responsibilities • Lead site-level food safety strategy for high-volume, ready-to-eat meal production, ensuring alignment with CookUnity's growth, retention, and marketplace objectives, • Serve as the primary food safety authority for regulatory agencies, third-party audits, and inspections; own inspection readiness, execution, and corrective action management, • Oversee preventive control programs and critical limits, including cold-chain management, sanitation systems, chemical controls, and cook-chill processes, • Analyze, trend, and interpret food safety and environmental monitoring data to proactively identify risk and drive continuous improvement, • Design, implement, and scale food safety programs, including internal and Chef audits, shelf-life validation, environmental monitoring, and risk assessments, • Partner with Operations and Culinary leaders to integrate food safety into production planning, new menu launches, and process innovation, • Lead food safety investigations, root cause analysis, and CAPA programs to prevent recurrence and strengthen systems, • Develop and deliver engaging training programs for GMPs, sanitation, allergen control, and safe food handling for employees and Chef partners, • Build and mentor high-performing food safety team members, fostering technical excellence and leadership capability, • Translate evolving federal, state, and local regulations into clear, practical standards that support speed, consistency, and compliance, • Champion a strong, proactive food safety culture across multiple shifts and teams in a fast-paced environmentQualifications, • Bachelor's degree in Food Science, Microbiology, Food Safety, or a related discipline; advanced degree preferred, • HACCP, PCQI, and/or Certified Food Safety Manager credentials, • 7+ years of progressive experience in food safety, quality, or regulatory leadership within ready-to-eat, fresh, or high-compliance food production environments, • Demonstrated success leading food safety programs at scale in complex, high-growth operations, • Strong working knowledge of FDA, USDA, and local regulatory requirements, preventive controls, and HACCP systems, • Proven ability to influence cross-functional leaders and drive change without direct authority, • Excellent communication, training, and stakeholder engagement skills, • Highly analytical, detail-oriented, and comfortable working with performance data and risk metrics 🌅 401k Plan 📈 We grow, you grow: Stock Options Plan granted on Day 1 🌟 Eligible for a bi-annual performance bonus ⛱ Unlimited PTO 🗓️ 5-year Sabbatical: After 5 years with CookUnity, you get a 4-week paid sabbatical 🐣 Paid Family Leave 🕯 Compassionate Leave: 3–5 days each time the need arises 🥘 Monthly CookUnity credits to enjoy our meals 🧘🏽️‍♀️ Wellness perks: nutritional coach access and fitness subsidies 👩🏾️‍🏫 Personalized Spanish coach 🌟 Opportunity to join a company that's redefining how we eat and how chefs work Compensation All final pay rates will be determined by candidates experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.Pay Range for this position$140,000—$160,000 USD If you're interested in this role, please submit your application, and if we think you might be a fit, we'll get in touch with you. Thank you for your time! CookUnity is an Equal Opportunity Employer. We are dedicated to creating a community of inclusion and an environment free from discrimination or harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, citizenship status, protected veteran status, genetic information, or physical or mental disability. A quick note for all candidates We've recently seen an increase in recruitment scams across the industry, and we want to make sure you (and your data) stay safe while applying to CookUnity. We also want you to know that we take this seriously — sometimes, as part of our process, we may ask for a brief "proof of humanity" to confirm that we're connecting with a real person, not an impersonator. Here are a few tips to help you protect yourself and know what to expect from us: • Apply only through our official channels. All open roles are listed on our official careers page: careers.cookunity.com, • Our recruiters are real people — and easy to verify. You can always find them on LinkedIn with verified profiles. If you're unsure, feel free to reach out to us on our official LinkedIn Company Page., • We only communicate through official CookUnity channels. That means emails ending in @cookunity.com and interviews held through official company platforms (Google Meet or Zoom) — never WhatsApp, Telegram, or SMS.

Job DescriptionABOUT PROJECT HEALTHY MINDS Project Healthy Minds is a mental health tech non-profit startup. We are pioneering a first-of-its-kind model: applying technology to address one of the biggest social issues of our time: the growing mental health crisis. We believe in a simple but profound idea: that it should be as easy to find mental health services as it is to book a flight or a restaurant reservation. That's why we're building the world’s first digital marketplace for finding mental health services that are right for you. To do that, we work with some of the most inspiring and influential leaders in America - business titans, tech entrepreneurs, clinicians and scientists, musicians, artists, athletes, media stars, policymakers, and more - because we believe that the world's most complex challenges require interdisciplinary teams and solutions. We are backed by a powerhouse of industry-leading Board of Directors and Advisory Council Members who are passionate, hands-on, and dive into the important work with us. Learn more at projecthealthyminds.com and @projecthealthyminds on social. ABOUT THE ROLE WHAT WE’RE LOOKING FOR: The Manager, Fundraising & Special Events is a mission-driven, detail-obsessed, highly organized events professional who will support and help execute Project Healthy Minds’ ambitious slate of fundraising and cultivation events. Reporting to the Senior Strategic Events, Fundraising & Production Lead, this role plays a critical part in producing elevated, culturally resonant experiences—from large-scale signature fundraisers to intimate VIP salon dinners, corporate partner activations, and national parlor gatherings. Project Healthy Minds' events are a critical engine for fundraising, storytelling, and community building. This role ensures that every experience reflects the excellence, creativity, and care our mission deserves. The Manager, Fundraising & Special Events will be an essential partner in scaling a national events program that sparks deeper connection, inspires generosity, and brings the movement for mental health to life. This person thrives in a fast-paced, creative environment and is excited by the challenge of helping a growing nonprofit build a world-class events program. They bring a strong production foundation, impeccable project management, and a collaborative mindset. The ideal candidate is equal parts logistics pro, relationship builder, and brand ambassador. HOW YOU’LL CONTRIBUTE: Event Planning & Production Support• Work closely with the Senior Strategic Events, Fundraising & Production Lead to execute the full Project Healthy Minds events calendar, including signature fundraisers, salon & parlor events, corporate activations, and wrap-around programming events.• Support end-to-end production, including timelines, run-of-show drafts, vendor coordination, venue walkthroughs, deliveries, load-in/out schedules, staffing plans, and onsite event management.• Manage logistics for smaller events independently, serving as the day-to-day lead under the Senior Strategic Events, Fundraising & Production Lead's strategic direction.• Assist with event design & vendor sourcing.• Maintain strong relationships with event production companies, A/V teams, rental partners, caterers, printers, photographers, and transportation/lodging partners.• Track vendor deliverables, deadlines, and invoices; support budget reconciliation. Guest Experience & Donor Stewardship• Ensure a seamless guest experience across invitation, registration, arrival, program, and post-event follow-up.• Support thoughtful stewardship practices, including personalized follow-up, recognition touchpoints, and donor engagement tracking. Project Management & Internal Coordination• Manage guest lists, RSVP tracking, seating charts, and check-in tools in close collaboration with the Revenue team.• Support talent, speaker, and guest communications, including event prep materials, schedules, and hospitality.• Support creation and maintenance of detailed event project plans, production schedules, and internal workstreams.• Support the creation of briefing documents, scripts, call sheets, run-of-shows, floor plans, and internal memos. Fundraising & Development Support• Partner with the Revenue team to support sponsorship deliverables and activation needs.• Assist with solicitation materials, sponsor fulfillment, and post-event stewardship touchpoints.• Help prepare reporting, recaps, and metrics for internal and external audiences.• Support prospect research related to events and cultivation efforts, including identifying, qualifying, and briefing potential donors, sponsors, and hosts in partnership with the Development Operations teams.• Assist with building and maintaining prospect pipelines tied to events, including tracking engagement history, relationships, and next steps in the CRM.• Prepare concise donor and prospect briefing materials (profiles, talking points, giving context) to support senior leadership, board members, and hosts • Support pre and post-event fundraising strategy by helping identify follow-up opportunities, stewardship priorities, and cultivation pathways stemming from event engagement. ABOUT YOU OUR IDEAL CANDIDATE:• 5–7 years of experience in special events, production, nonprofit fundraising events, or related fields.• Strong project management skills -- you love a timeline, a tracker, and a well-organized Google Drive.• Comfort working with vendors, production teams, and high-profile stakeholders.• A proactive, “no job too big or too small” attitude; willingness to dive in at every level of execution.• Excellent communication skills, professionalism, and discretion when working with VIP guests, donors, and partners.• Strong aesthetic sensibility and interest in design, culture, talent, and storytelling.• Experience with CRM, project management, guest list platforms, or event management tools is a plus (e.g., Salesforce, Monday.com, Zkipster).• Ability to thrive in a fast-moving environment with shifting priorities.• A passion for mental health and the mission of Project Healthy Minds. WHAT WE OFFER

Job Description QC Chemist position Position Responsibilities * • Perform QC Chemistry tests on incoming raw material, • Perform Water System tests and controls – Must be experienced., • Assist in the execution of equipment qualification and validation projects as required, • Perform Chemistry tests for products on stability, • Perform in-process testing and batch record review, • Calculate, record, and compile reports on assays, • Perform IQ, OQ & PQ (Qualification/Validation) of analytical instruments, • Perform calibration of laboratory instruments, • Author and revise QC Chemistry SOPs, • Routine QC activities. Document work according to established SOP’s., • Perform microbiologic testing Education: • Knowledge of cGMPs and area SOPs, • Knowledge of USP Water Systems is a must, • Must have strong interpersonal and teamwork skills, • Knowledge of the pharmaceutical manufacturing environments and processes, • Substantial experience performing QC testing of bulk, final, and stability pharmaceutical products.

Job Description A cuttingedge biotechnology company is seeking a Senior Director, Regulatory Affairs to lead global regulatory strategy across a portfolio of innovative, highimpact programs. This team is composed of world-class scientists and innovators who are leading the charge on integrating advanced imaging and AI technologies to revolutionize drug discovery The Senior Director, Regulatory Affairs will oversee the design and execution of regulatory strategies from early development through registration, ensuring alignment with U.S. and international requirements. The ideal candidate will bring deep expertise in global regulatory pathways, exceptional leadership in crossfunctional settings, and the ability to provide strategic guidance across R&D, Clinical, and Quality functions while serving as a key liaison with regulatory authorities. Responsibilities: • Develop and execute comprehensive regulatory strategies supporting development, approval, and commercialization., • Ensure alignment of regulatory plans with corporate objectives and clinical development goals., • Maintain deep awareness of evolving U.S. and global regulations, guidelines, and industry standards., • Ensure all company activities and programs adhere to applicable regulatory requirements., • Oversee the preparation, review, and delivery of regulatory submissions such as INDs, NDAs, BLAs, and MAAs., • Ensure submission packages are scientifically sound, strategically positioned, and delivered on time., • Partner closely with Clinical Development, Research, Quality, CMC, and other key stakeholders to integrate regulatory considerations into development programs., • Provide clear, proactive regulatory guidance across program teams., • Support regulatory aspects of quality systems, including adherence to GCP, GLP, and other relevant standards., • Ensure inspection readiness and alignment with regulatory expectations., • Identify regulatory risks and develop mitigation strategies across programs and functions., • Anticipate potential regulatory challenges and proactively guide teams toward solutions. Qualifications • Postgraduate degree with 12+ years of regulatory affairs experience, or bachelor's degree with 15+ years of relevant experience., • Prior experience as a people manager is a requirement, • Extensive knowledge of FDA and global regulatory requirements and guidelines., • Proven experience supporting regulatory strategy across all stages of the product lifecycle, • Oncology experience is a plus, • Proven leadership experience in developing and executing regulatory strategies., • Strong communication, negotiation, and crossfunctional partnership skills., • Analytical, detailoriented, and solutionsfocused, with the ability to operate in a fastpaced environment., • Demonstrated adaptability and readiness to lead in a highgrowth, innovationdriven setting. Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints. Job Responsibilities: -\tConducting Post Market Activities and Post Market Surveillance -\tManaging Customer and Product Complaint Investigation programs Education and Experience: -\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry -\tBachelor's degree -\tComputer proficiencyA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities:\r\n•\tConducting Post Market Activities and Post Market Surveillance\r\n•\tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience:\r\n•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r\n•\tBachelor's degree\r\n•\tComputer proficiency

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Team You will join our expert Computational Imaging team, where we develop sophisticated algorithms to enhance and improve medical imaging. We are focused on improving the quality and clinical value of medical images, creating powerful, extra software components that correct artifacts, standardize data, and ensure the utmost precision before the final analysis. Our work is essential for elevating the reliability and accuracy of Cleerly's regulated products. Responsibilities • Research and develop state-of-the-art AI and non-AI algorithms for coronary CT imaging applications., • Translate product and clinical requirements into algorithmic specifications in collaboration with Product and Clinical teams., • Partner with Regulatory Affairs to support regulatory submissions (e.g., 510(k), De Novo,PCCP), including generating evidence and documentation., • Collaborate with engineering teams to deploy AI and non-AI based solutions in clinical practice., • Communicate findings and strategy to internal stakeholders and leadership through clear technical documentation, presentations, and demos., • Contribute to intellectual property development through patents and scientific publications., • Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field, with 5+ years combined postdoc and/or industry experience; OR an M.S. with 8+ years of relevant experience., • R&D experience in medical image processing, demonstrating subject matter expertise in deep learning methods for image quality enhancements, optical flow analysis and CT harmonization., • Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis)., • Strong experience in Python, Tensorflow and pytorch., • Prior experience with ITK, OpenCV, VTK., • Excellent interpersonal, cross-functional, and cross-cultural collaboration skills., • 5+ years of industry experience in AI-based medical device development or clinical deployment., • Experience supporting FDA regulatory submissions for ML-based software, including familiarity with De Novo, 510(k), and PCCP pathways. *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job Description Position Summary: The Engineering Director – Product Engineering position oversees project management and addresses supply and design-related matters for the released portfolio of company products. The company device is a medical system integrating multiple engineering disciplines, utilizing both capital equipment and disposable components to support liver transplants and improve organ availability. Responsibilities include developing new features within the lifecycle management of the current product range. This role involves leading cross-functional teams to identify issues, develop corrective action plans, and implement solutions related to both technical product matters and broader product development challenges. This position requires interaction with upper management for project reporting and phase reviews. The role encompasses experience with various therapies, products, and operational considerations connected to patient care and business objectives. Major Responsibilities: As the leader of a small multi-disciplinary Product Engineering team, and under the direction of the SVP, Product Engineering, the successful incumbent will drive activities in the following areas: • Lead cross-functional team members to ensure clear communication and coordination of project/program objectives, deliverables, and timing of key milestones., • Orient quickly to understand new quality issues based on field or factory performance, and to concurrently manage multiple projects with different teams and while balancing competing priorities., • May take direct responsibility for design-related CAPAs (Corrective and Preventive Action) within the Product Engineering department as well as process focused CAPAs., • Author investigation (i.e., root cause analysis) plans, reports, and supporting documents of high quality (i.e., submission and audit/inspection ready) that are technically sounds, critically reasoned, and use appropriate root cause tools/methodologies (e.g., 5-Whys/Cause Map, Contradiction Matrix, other DRM/Six Sigma problem-solving and statistical analyses)., • Provide clear and concise communication – both written and verbal., • Author strong documentation with attention-to-detail that is audit-ready., • Present team's investigation findings and action recommendations to quality (e.g., CAPA Board) and other management/business stakeholders., • Plan schedule and resources (e.g., labor skills sets and duration, expenses) to achieve desired project outcomes., • Responsible for maintaining a focus on quality, while effectively partnering with Quality, R&D, Operations, and Regulatory stakeholders to facilitate consensus, resolve disagreements, and ensure sound decision-making., • Experience in the medical device or highly regulated industry., • Experience or technical education in software development, software or computer engineering, and/or software quality assurance, including knowledge of IEC 62304 (Medical device software – software life cycle processes)., • Experience with medical device systems that include software applications and/or embedded software (i.e., firmware)., • Experience leading a complex project/program, including cross-functional team leadership, risk-based decision making, financial accountability, and ability to manage change implementation., • Background with CAPA (Corrective and Preventive Action) process, and/or experience with the use of root cause investigation, problem-solving, or similar structured methodologies and tools (e.g., 5-Whys, Fishbone, etc.), • Experience participating in or supporting audits or external inspections (e.g., FDA, TUV, internal audit)., • Proven experience in achieving results through influence management and motivating teams., • Knowledge and/or experience with product development processes and/or QMS (Quality Management System) Design Control procedures., • Strong understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, Medical Device Directive, and European Medical Device Regulation., • Requires a bachelor's degree in engineering and a minimum of 5 years of relevant experience, or an advanced degree with a minimum of 3 years of relevant experience., • Certified practitioner in Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), or Lean Sigma methodologies., • Ability to travel 15%

Job Description About Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking an experienced IRB Coordinator to join our exceptional team as a full-time Vitalief employee. In this role, you will support a leading hospital research center in Livingston, NJ, administering and overseeing Institutional Review Board (IRB) activities to ensure compliance with federal, state, and institutional regulations governing human subjects research. This role supports investigators, staff, and IRB members in the preparation, review, and approval of research protocols, while also assisting with Nussbaum grant activities. WHY VITALIEF? • Contribute to advancing scientific discoveries that improve patient lives., • PEOPLE FIRST culture with opportunities for growth and innovation., • Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans. Responsibilities: • Under the direction of the Director of Graduate Medical Education and Clinical Research, coordinate and manage all IRB activities, meetings, and communications., • Review protocol submissions for completeness and accuracy; recommend appropriate level of review., • Draft and issue correspondence reflecting IRB deliberations and decisions., • Provide regulatory and methodological guidance to investigators, staff, students, and IRB members., • Maintain compliance with OHRP, FDA, ICH/GCP, and institutional regulations., • Manage IRB databases, tracking systems, and protocol documentation., • Assist with emergency use protocols and special meetings as needed., • Schedule and support Institutional Research Committee meetings, prepare agendas/minutes, and follow up on action items., • Collaborate with other system IRB Coordinators and departmental staff., • Bachelor’s degree in a scientific or health-related field required; Master’s degree preferred., • Three (3) years of experience in clinical research and research administration, including two (2) years of IRB operations experience., • Strong understanding of IRB regulations, ethical research standards, and ICH/GCP guidelines., • Excellent written and verbal communication skills., • Ability to demonstrate professionalism, clear communication, and respect in all interactions., • Passionate in supporting teamwork and collaborative problem-solving., • Apply continuous quality improvement principles to research operations., • Work independently with accountability, sound judgment, and openness to feedback., • Strong organizational and time management abilities; must be self-motivated and able to multi-task on a variety of projects., • Detail-oriented with strong organizational and follow-up skills., • Proficiency with Microsoft Office (Word, Excel, PowerPoint); database management experience preferred., • Certified IRB Professional (CIP®) is a plus., • Knowledge of medical terminology preferred. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR oj96ccgxpc

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

Job Description About the Job We are seeking an experienced Senior Quality Systems Specialist to join Synchron’s Quality team. This is an amazing opportunity to shape the future of Synchron’s Quality Management System (QMS) and contribute to the Culture of Quality at the company. We are looking for candidates with experience working within FDA regulated industries (preferably medical devices) and who have experience performing document control within an eQMS (preferably Arena). The ideal candidate will be detail-oriented, process-driven, and comfortable working cross-functionally in a growing company with evolving needs. Synchron is a “patient first” company full of mission-driven people. We are looking for someone who shares our passion for problem-solving and doing right by our patients. If this sounds like you, then we invite you to apply and join the team! Job Location New York, NY (on-site). Travel is generally not expected but may be needed infrequently for supplier audits. Job Responsibilities • Document Control, • Own the Document Control process, including processing change requests and executing change orders for documents inSynchron’seQMS(Arena),identifyingimprovement opportunities for the process, and educating company personnel on Document Control best practices, • eQMSAdministration, • Administer and manage the Arena electronic Quality Management System including configuration, account allocation, and license management, • Training Management, • Own the Personnel Training process in the QMS, includingdetermininginitial Quality Training needs, assigning employee Quality Training Plans, monitoring training completion,maintainingtraining records and certifications, anddeterminingaccess to theeQMSand development tools for new hires, • QMS Process Development, • Drivethe maintenance and development of existing and new Synchron SOPs/documentation to meet Synchron business needs, current regulations, and industry standards by employing industry experience and knowledge of QMSR, GLP, GMP and FDA compliance standards, • Quality Process Execution, • Own the execution of processes associated withhandling ofclinical product, including incoming inspection, inventory management, product distribution, and product returns, • Support processes including Design Control, Change Management, CAPA, Product Feedback, and Nonconformances by guiding project teams to develop recordsin accordance withinternal procedures, • Support non-product software tool assessments and validations related to the QMS, • Management Reviews, • Support Quality Management Reviews, including taking meeting minutes, preparing data and information for the review, and publishingthereview in the QMS, • Audits, • Assistwith audit preparation and execution, resolution of audit findings,interfacewith auditing groups and inspectors through all stages of audits, and perform or oversee contractorsforaudits of critical suppliers, • General, • Use continuous improvement mindset to improve quality tools and processes, • Use creative problem solving to partner with cross-functional team members to respond to and resolve issues, • Foster a culture of quality through collaboration, partnership, teamwork, and a drive for change and continuous improvement, • Bachelor’s degree, preferably in the sciencesbut we are open todifferent backgrounds, • 5+ years of experience working within a Quality Management System in an FDA regulated environmente.g.medical device,pharmaceutical,orbiotech, • We are open to candidates withvarying levels of experiencesoif you believe your skillset aligns withthe rolewestillencourage you toapply, • Knowledge and understanding of medical device Quality Management Systems and applicable regulations and standards including 21 CFR 820 and ISO 13485:2016, • Experience using an electronicQuality/DocumentManagementSystem (preferably Arena), • Demonstrated ability to perform detail-oriented work with a high degree of accuracy, • Excellenttime management,organizational,and planning skills, • Effective written and oral communication skills, • Possesses initiative and is proactive, • Must work effectively within teams with rapidly changing priorities, • Builds productive internal and external working relationships, • Experience with class III medical devices in an area such as neuromodulation, vasculardevicesor cardiac rhythm management, • Experienceparticipatingin quality inspections and performing supplier quality audits, • Experiencesupporting investigational devices undergoing clinical trials, • ISO 13485:2016 Lead Auditor Certification Compensation The base salary range for this role is $120,000– $160,000, depending on experience, skills, and qualifications. In addition to base pay, this role may be eligible for discretionary bonuses and/or equity grants subject to board approval and company policy. Work Authorization Notice Synchron hires only individuals who are authorized to work in the United States. At this time, visa sponsorship is not offered for this role. Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible • Subsidized medical and dental insurance coverage for you and your dependent(s), • Life insurance, short-term disability, long-term disability, • 401k, • Discretionary unlimited PTO, • Flexible Spending Account for you and your dependent(s), with eligible plan elections, • Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply and now and build the future with us.