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

Job DescriptionJob Title: Research Chemist (Medical Device) Job Description: • The R&D Chemist plays a key role in advancing innovative medical devices based on regenerative technologies., • This position combines hands-on laboratory research with product development responsibilities, including experimental design, material characterization, prototype development, and compliance with design control requirements., • The scientist will work independently on defined projects, contribute to cross-functional teams, and support the smooth transfer of products into manufacturing., • Plan, execute, and analyze laboratory experiments involving biomaterials, regenerative matrices, and medical device components., • Contribute innovative ideas for new products, testing methods, or process improvements to enhance R&D capabilities., • Develop, build, and refine prototypes to meet defined specifications and clinical needs., • Generate accurate technical documentation, reports, and protocols in compliance with FDA and Control requirements., • Characterize materials and prototypes using analytical, biochemical, and mechanical testing methods., • Perform risk assessments, troubleshoot technical issues, and propose solutions to improve product performance or process robustness., • Support technology transfer from R&D to manufacturing, including process documentation, validation support, and training of personnel., • Collaborate with cross-functional teams (Manufacturing, Quality, Regulatory, Marketing, and Clinical) to align product development with business and clinical requirements., • Engage with external consultants and customers to gather feedback and translate needs into product features., • Mentor and provide technical guidance to junior staff on laboratory practices, data analysis, and project tasks., • Present findings and project updates to management, peers, and cross-functional stakeholders., • Strong proficiency in laboratory research and development., • Expertise in biomaterials, regenerative technologies, or medical device research and development., • Knowledge of laboratory techniques for material characterization, tissue-derived biomaterials, or device testing., • Familiarity with Design Controls, GLP/GMP, and industry standards., • Proficiency in experimental design, data/statistical analysis, and technical problem-solving., • Strong organizational skills with the ability to manage multiple studies and projects simultaneously., • Excellent communication and presentation skills for cross-functional collaboration., • MS with 1–2 years or BS with 3–5 years in Biomedical Science, Materials Science, Chemistry, or related field. The role involves working within a team of one other Scientist and three Engineers in a GMP environment. The position requires collaboration with a cross-functional team and adherence to safety and operational standards. Job Type & Location This is a Permanent position based out of Paramus, New Jersey. Pay and Benefits The pay range for this position is $85000.00 - $95000.00/yr. Great benefits / medical benefits start 1st day, 401k requiring no employee contribution, frequent employee activities Workplace Type This is a fully onsite position in Paramus,NJ. Application Deadline This position is anticipated to close on Oct 9, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description Experience Required: 5 Years Education Level: Bachelor's Degree Job Function: Accounting/Auditing Industry: Pharmaceuticals Relocation Assistance: No Visa Sponsorship Eligibility: No Job Summary: The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with current Good Manufacturing Practice (cGMP), regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes. Key Responsibilities: • Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers., • Prepare detailed audit plans, checklists, and schedules to ensure comprehensive audits., • Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines., • Review and approve deviations, CAPAs, and change controls., • Document audit observations and issue formal audit reports., • Track and verify implementation of corrective and preventive actions (CAPAs)., • Guide compliance requirements and audit readiness., • Support regulatory inspections and customer audits., • Identify systemic issues and recommend process improvements to enhance efficiency and effectiveness., • Stay updated on evolving regulatory requirements and industry best practices. Qualifications: • Bachelor's degree in Life Sciences, Pharmacy, or related field., • 3–5 years in Radio Pharmaceuticals, with at least 2 years in auditing, • Strong knowledge of RPT cGMP, GDP, and global regulatory requirements., • Excellent attention to detail and analytical skills., • Strong communication and report-writing abilities., • Ability to travel (up to 10%) for audits. Preferred Certifications: • ASQ Certified Quality Auditor (CQA), • ISO 9001 Lead Auditor, • GCP/GMP auditing certifications

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

Job Description About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit . How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact • Patient Coordination, • Prescreen study candidates, • Obtain informed consent per Care Access Research SOP., • Complete visit procedures in accordance with protocol., • Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc., • Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion., • Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff., • Prioritize activities with specific regard to protocol timelines, • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials., • Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives., • Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate), • Documentation, • Record data legibly and enter in real time on paper or e-source documents, • Accurately record study medication inventory, medication dispensation, and patient compliance., • Resolve data management queries and correct source data within sponsor provided timelines., • Assist regulatory personnel with completion and filing of regulatory documents., • Assist in the creation and review of source documents., • Patient Recruitment, • Assist with planning and creation of appropriate recruitment materials., • Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database., • Actively work with recruitment team in calling and recruiting subjects, • Other Responsibilities, • Review and assess protocol (including amendments) for clarity, logistical feasibility, • Ensure that all training and study requirements are met prior to trial conduct., • Communicate clearly verbally and in writing., • Attend Investigator meetings as required., • Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords), • Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management, • Maintain effective relationships with study participants and other care Access Research personnel.The Expertise Required, • Ability to understand and follow institutional SOPs., • Excellent working knowledge of medical and research terminology, • Excellent working knowledge of federal regulations, good clinical practices (GCP), • Ability to communicate and work effectively with a diverse team of professionals., • Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail, • Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel., • Critical thinker and problem solver, • Friendly, outgoing personality; maintain a positive attitude under pressure., • High level of self-motivation and energy, • Excellent professional writing and communication skills, • Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience:, • Bachelor's Degree preferred, or equivalent combination of education, training and experience., • A minimum of 1-year prior Clinical Research Coordinator experience required, • Recent phlebotomy experience required How We Work Together, • Location: Position requires onsite work 5 days per week at either the Yonkers, NY., • Travel: This role requires up to 10% travel within 100 miles of site. Length of travel will depend upon study requirements, staff needs, and company initiatives., • Physical demands associated with this position Include:, • Walking-20%, • Standing-20%, • Sitting-20%, • Lifting-20%, • Up to 25lbs Overhead, • Driving-20%Benefits & Perks, • Paid Time Off (PTO) and Company Paid Holidays, • 100% Employer paid medical, dental, and vision insurance plan options, • Health Savings Account and Flexible Spending Accounts, • Bi-weekly HSA employer contribution, • Company paid Short-Term Disability and Long-Term Disability We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to:

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Job Summary: Manage the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH, and Regulatory requirements. This is a hybrid position that requires two days in the Paramus, NJ office. Essential Duties/Responsibilities: • Assist in planning, implementing, manage and reporting for regional or global clinical studies., • Manage selection process of CROs for regional or global clinical studies., • Manage the performance of study vendors (e.g., CROs and central labs), • Manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans, • Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.), • Tracking clinical data, regulatory documents, and patient enrollment information and data resolutions to ensure the timely completion of clinical studies in line with approved clinical development plans., • Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to ensure that the studies are conducted fulfilling the requirements of the study protocols., • Coordinate negotiation of clinical trial contracts between investigational sites and CROs., • Manage data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan., • Support for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites., • Implement project specific training program and training materials., • Support Creating and maintaining clinical SOPs and inspection-ready TMF as part of global QMS and TMF processes., • Perform administrative tasks (e.g., coordination, schedules, submission, filing, etc.)., • Must be able to manage and coordinate with the Clinical Lead to achieve project objectives and able to manage/solve project management performance issues if they arise., • Demonstrated ability to support the development and management of various aspects of the end-to-end study operational plan., • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners, and vendors., • Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies., • Ability to manage multiple tasks and prioritize., • Strong organizational, communication and presentation skills., • Team player, flexible, ability to adapt to change., • Bachelor’s degree in sciences or related field with a minimum of 5 years of pharmaceuticals/biotech experience in a matrix environment, • Minimum of 5 years of drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials. NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $150,000 to $175,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training NS Pharma is an EEO employer.

Job Description Nurse Manager – Oncology Clinical Research Are You Ready to Lead with Purpose in Oncology Research? • Do you thrive in complex, high-acuity settings where research and clinical care intersect?, • Are you passionate about advancing cancer treatment through cutting-edge trials and protocol oversight?, • Do you have experience managing oncology research teams and ensuring compliance across multi-phase studies? Why Choose Us? Join a team that values more than just your credentials. Here's what makes this opportunity stand out: • Respected Cancer Research Program: Become a key leader in a clinical research unit that supports early-phase to post-market oncology trials in a nationally regarded cancer setting., • Purpose-Driven Environment: Contribute to life-changing studies while upholding the highest standards of patient care, ethics, and scientific integrity., • Autonomous Leadership Role: Lead operations and personnel in oncology clinical research, with direct accountability for safety, compliance, documentation, and results., • Robust Infrastructure: Work alongside physicians, research coordinators, data managers, and regulatory teams in a collaborative, high-functioning model., • Planned Transition: This role is open due to an upcoming retirement, offering a stable foundation and collaborative onboarding plan., • Recognition and Growth: Join an organization recognized for nursing excellence and professional development opportunities across leadership levels. What's In It for You? • Competitive base salary with leadership incentives, • Generous PTO, paid holidays, and sick time, • Comprehensive health, dental, vision, and life insurance, • 401(k) retirement plan with employer matching, • Professional development funding and CME support, • Relocation assistance available, • Participation in research symposia, IRB engagement, and study planning committees, • Work within a Magnet-recognized nursing environment committed to integrity and innovation Discover Northern New Jersey Whether you're local or considering relocation, here's why this location is a great place to grow: • Well-Connected: Just minutes from NYC, major highways, and international airports, • Top-Rated Living: Great schools, safe communities, and suburban convenience, • Culture + Recreation: Close to performing arts, dining, outdoor activities, and sports venues, • Smart Value: Access to world-class healthcare institutions and affordable living Role Overview As the Nurse Manager for Oncology Clinical Research, your responsibilities will include: • Managing day-to-day operations of 25 oncology research nurses across multiple clinical trials, • Overseeing protocol compliance, informed consent processes, investigational drug handling, and safety monitoring, • Ensuring adherence to all internal policies, GCP standards, and federal regulations (FDA, IRB, etc.), • Coaching and mentoring RN staff, research coordinators, and other clinical team members, • Overseeing staffing, payroll, scheduling, equipment, and resource allocation, • Managing data collection integrity, deviation tracking, adverse event reporting, and audit readiness, • Collaborating with PI(s), regulatory teams, CROs, and sponsors for protocol execution and trial success, • Participating in clinical research committees, accreditation activities, and strategic planning initiatives Qualifications Required: • Bachelor's Degree in Nursing (BSN), • Active NJ RN license, • AHA Basic Life Support (BLS) Certification, • Minimum of 3 years RN experience in oncology and/or clinical research, • Master's degree in Nursing or Healthcare Administration, • National certification in oncology or clinical research (e.g., OCN®, CCRP), • 3+ years of progressive nursing leadership, especially in clinical research or academic settings What Their Team Says “This role bridges patient care and discovery. We're shaping the future of oncology, and nurse leaders are a vital part of that.” – Clinical Trials Director “It's exciting, complex, and deeply rewarding. You'll never be bored—and your work will truly matter.” – Senior Research RN Ready to Lead Research That Makes a Difference? If you're a seasoned clinical leader with a passion for oncology research and team development, we want to hear from you. Apply today for a confidential conversation.

Job Description Sr. Auditor needs 35 years in Radio Pharmaceuticals, with at least 2 years in auditing. Sr. Auditor requires: Skills: cGMP, GDP, FDA, EMA, ICH, RPT cGMP, regulatory inspections, customer audits, CAPA, deviations, change controls, audit planning, audit checklists, audit schedules, audit reporting, process improvements, compliance requirements, audit readiness, report writing, analytical skills, communication skills, pharmaceutical quality system (PQS), auditing, ISO 9001, GCP, GMP, ASQ Certified Quality Auditor (CQA) • Bachelors degree in Life Sciences, Pharmacy, or related field., • Strong knowledge of RPT cGMP, GDP, and global regulatory requirements., • Excellent attention to detail and analytical skills., • Strong communication and report-writing abilities., • Ability to travel (up to 10%) for audits., • ASQ Certified Quality Auditor (CQA), • ISO 9001 Lead Auditor, • Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers., • Prepare detailed audit plans, checklists, and schedules., • Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines., • Review and approve deviations, CAPAs, and change controls., • Document audit observations and issue formal audit reports., • Track and verify implementation of corrective and preventive actions (CAPAs)., • Provide guidance on compliance requirements and audit readiness., • Support regulatory inspections and customer audits.

Job Description Job Summary: The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes. Key Responsibilities: • Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers., • Prepare detailed audit plans, checklists, and schedules., • Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines., • Review and approve deviations, CAPAs, and change controls., • Document audit observations and issue formal audit reports., • Track and verify implementation of corrective and preventive actions (CAPAs)., • Provide guidance on compliance requirements and audit readiness., • Support regulatory inspections and customer audits., • Identify systemic issues and recommend process improvements., • Stay updated on evolving regulatory requirements and industry best practices. Qualifications: • Bachelors degree in Life Sciences, Pharmacy, or related field., • 35 years in Radio Pharmaceuticals, with at least 2 years in auditing., • Strong knowledge of RPT cGMP, GDP, and global regulatory requirements., • Excellent attention to detail and analytical skills., • Strong communication and report-writing abilities., • Ability to travel (up to 10%) for audits. Preferred Certifications: • ASQ Certified Quality Auditor (CQA), • ISO 9001 Lead Auditor, • GCP/GMP auditing certifications

Job Title: Quality Assurance Auditor – Radiopharmaceuticals Location: Paramus, NJ, 07652 Job Type: Temporary Assignment Duration: 5+ Months Work Type: Onsite Shift: 9.00AM-5.00PM Pay Rate: $ 60.00-67.00/ Hourly Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Job Description: Summary: • The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards., • Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers., • Prepare detailed audit plans, checklists, and schedules., • Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines., • Review and approve deviations, CAPAs, and change controls., • Document audit observations and issue formal audit reports., • Track and verify implementation of corrective and preventive actions (CAPAs)., • Provide guidance on compliance requirements and audit readiness., • Support regulatory inspections and customer audits., • Identify systemic issues and recommend process improvements., • Bachelor’s degree in Life Sciences, Pharmacy, or related field., • 3–5 years in Radio Pharmaceuticals, with at least 2 years in auditing., • Strong knowledge of RPT cGMP, GDP, and global regulatory requirements., • Excellent attention to detail and analytical skills., • Strong communication and report-writing abilities., • ASQ Certified Quality Auditor (CQA), • ISO 9001 Lead Auditor

Job Description Oncology Research Project Manager Are you a strategic leader with a passion for driving oncology research forward? Do you thrive when mentoring teams, managing complex clinical trials, and delivering results in a fast-paced environment? Do you see opportunity in innovation and satisfaction in contributing to meaningful cancer breakthroughs? If this sounds like you, read on—you might be the perfect fit for our nationally recognized Cancer Center in the vibrant Northern New Jersey region. Overview A nationally recognized Cancer Center within a prominent Health Network in Northern New Jersey is seeking a Manager of Oncology Research Project Management to lead a team of seven Clinical Research Project Managers. This individual will not only manage and mentor the team but will also oversee complex oncology clinical trials within a designated research division—such as Phase I, solid tumors, hematologic malignancies (leukemia, lymphoma, myeloma), BMT, or investigator-initiated trials. This is a high-impact leadership opportunity in a collaborative, mission-driven environment focused on advancing cancer science and improving patient outcomes through cutting-edge clinical research. Why Join This Cancer Center? • Join a nationally ranked Cancer Center known for pioneering CAR T-cell therapy, precision oncology, and one of the largest bone marrow transplant programs., • Collaborate with world-renowned oncologists and physician-scientists., • Contribute to a research program with hundreds of ongoing Phase I-IV trials., • Lead a team of 7 project managers and manage high-impact research studies., • Participate in trials featuring advanced therapies like CAR T-cell and novel immunotherapies., • Work in a modern, expanded cancer research facility with innovation hubs., • Join a collaborative and outcomes-driven team focused on transforming cancer care. Employee Perks & Benefits • Competitive NYC metro-rate salary, • Generous PTO, health benefits (Medical, Dental, Vision), • 401a and 403b retirement plans, tuition reimbursement, • Disability coverage, FSA, and wellness/continuing education programs Living in Northern New Jersey • Discover the perfect balance of energy and tranquility in Northern New Jersey. Within close proximity to New York City, you'll enjoy the best of both worlds—urban excitement and peaceful suburban living., • Spend your weekends hiking the Appalachian Trail, catching a Yankees game, or exploring charming downtowns and farmers' markets., • From vibrant cultural experiences to award-winning dining and scenic parks, the region offers something for everyone., • And yes—you'll get all four seasons, with just enough snow in winter to make summer that much sweeter. Role Overview As the Manager of Oncology Research Project Management, you'll lead a team of 7 project managers overseeing complex clinical trials in oncology divisions such as Phase I, BMT, Lymphoma, Leukemia, Myeloma, and Solid Tumors. You'll manage your own portfolio of studies, guiding them from protocol development through final deliverables. Responsible for strategic planning, compliance, and cross-functional collaboration. Key Responsibilities • Lead and mentor a team of 7 project managers, • Oversee trials across multiple oncology specialties, • Manage budgets, timelines, deliverables, • Ensure FDA/GCP compliance, • Communicate with investigators, sponsors, and teams Leadership & Strategy • Develop and lead a high-performing team, • Oversee metrics, quality, and process improvements, • Promote innovation, accountability, and excellence Clinical Trial Operations • Oversee trials from protocol to close-out, • Collaborate with investigators and staff, • Act as liaison for stakeholders and regulators Compliance & Reporting • Ensure adherence to regulations and ethics, • Prepare KPIs, financial reports, executive updates, • Manage audits and site visits Qualifications & Experience • Bachelor's degree in life sciences or related field (Master's or PhD preferred), • 3+ years of oncology trial management; team leadership experience required, • Strong GCP/FDA knowledge; PMP/CCRP/CCPM a plus, • Familiarity with tumor types, therapies, and trial design Skills & Competencies • Excellent leadership and mentoring skills, • Deep regulatory understanding (FDA, GCP, IRB), • Effective multitasking and deadline management, • Strong communication with stakeholders and leadership Preferred Certifications • PMP (Project Management Professional), • CCRP (Certified Clinical Research Professional) Apply Now If you're ready to elevate your leadership career in clinical research and play a vital role in improving cancer care, we want to hear from you. Apply today to join a mission that truly matters.

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