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Job Description We are seeking a detail-oriented and dependable Pharmaceutical Batcher to join our growing team in Carlstadt, NJ. In this role, you will be responsible for operating industrial mixing and blending equipment to manufacture high-quality pharmaceutical products while adhering to strict quality, safety, and regulatory standards. The ideal candidate will have experience in pharmaceutical, chemical, food manufacturing, or other regulated production environments and possess a strong commitment to accuracy and compliance. Pay Rate: $20.00/hr and up (Based on Experience and Interview) Schedule: Monday-Friday | 8:30 AM - 5:00 PM Key Responsibilities • Accurately weigh, measure, and dispense raw materials, powders, liquids, and active ingredients according to batch specifications., • Follow Master Batch Records (MBRs) and Standard Operating Procedures (SOPs) to ensure precise product formulation., • Set up, operate, monitor, and troubleshoot industrial mixing, blending, and granulation equipment., • Record production data, including weights, temperatures, mixing times, and processing parameters, ensuring complete and accurate documentation., • Perform in-process quality checks, including sampling and testing to verify product specifications., • Maintain a clean and organized production environment while following strict sanitation and contamination control procedures., • Execute cleaning and sterilization protocols between production batches., • Adhere to all GMP (Good Manufacturing Practices), safety guidelines, and company policies., • Properly utilize required Personal Protective Equipment (PPE) and follow Lockout/Tagout (LOTO) procedures when necessary., • Collaborate with Quality Assurance, Production, and Warehouse teams to support efficient manufacturing operations. Qualifications • Previous experience in pharmaceutical, chemical, food manufacturing, nutraceutical, or related production environments preferred., • Ability to follow detailed instructions and batch records with a high level of accuracy., • Strong documentation and recordkeeping skills., • Ability to work in a fast-paced manufacturing environment while maintaining quality standards., • Comfortable working with industrial equipment, chemicals, and required safety procedures., • Basic computer skills and experience with ERP systems is a plus., • Ability to lift up to 50 pounds and stand for extended periods throughout the shift.\nCompany Description Many of those employed through JobConnection Services find that their positions are temp-to-hire. Our skilled office staff works to set each employee up for success! We ensure you have a clear picture of the responsibilities of the assignment you are going to, and work as a liaison between you and the client. A personal relationship that includes constant communication with our clients makes for a pain‐free temporary or permanent placement process - and that translates to happy employees! Stop in today - and feel free to bring a friend along! Many of those employed through JobConnection Services find that their positions are temp-to-hire. Our skilled office staff works to set each employee up for success! We ensure you have a clear picture of the responsibilities of the assignment you are going to, and work as a liaison between you and the client. \r\n\r\nA personal relationship that includes constant communication with our clients makes for a pain‐free temporary or permanent placement process - and that translates to happy employees!\r\n\r\nStop in today - and feel free to bring a friend along!

Job Description Pharmaceutical Manufacturing Packaging Machine Operators Needed in West Caldwell, NJ on All 3 Shifts! Position: Machine Operator Shift: 1st: 6am-2:30pm (Monday-Friday) 2nd: 2pm-10:30pm (Monday-Friday) 3rd: 10pm-6:30am (Sunday Night - Friday morning) Location: West Caldwell, NJ Pay: $22-$24/hour ; Overtime: $33-$36/hour Job Description The Packaging Operator plays a key role in pharmaceutical manufacturing by operating vial filling, fabrication, and secondary packaging equipment in a cleanroom environment. This role focuses on accurate and efficient packaging, strict adherence to Good Manufacturing Practices (GMP), and meticulous documentation to ensure product quality and compliance. The position requires hands-on work with packaging lines, labeling, inspection, and general production activities. Responsibilities • Operate vial filling machines, fabrication machines, and secondary packaging equipment, including labeling systems and semi-automatic packaging equipment, in accordance with GMP and standard operating procedures., • Clean, set up, and prepare manufacturing and packaging equipment prior to production runs to ensure proper operation and product safety., • Verify that all calibration stickers on equipment are current and accurate before use., • Record all required information in appropriate logbooks and batch records in a clear, accurate, and timely manner., • Palletize completed work and transport finished product to the warehouse as needed, following established handling procedures., • Complete downtime logs accurately and contemporaneously, documenting reasons for delays or stoppages and actions taken., • Meet established scrap rate goals by following procedures, monitoring equipment performance, and handling materials carefully., • Communicate effectively with IPC Operators and relevant team members regarding quality concerns, component issues, and machine performance., • Ensure that all reconciled labeling materials, including pouch stock, inserts, shipper labels, and waste, are properly accounted for and documented., • Report and communicate mechanical issues, production status, and other relevant information to incoming and outgoing shifts to support smooth handovers., • Apply knowledge of all relevant standard operating procedures (SOPs) in daily activities and ensure practical, compliant execution of tasks., • Perform visual inspection of products and packaging to identify defects or nonconformities and take appropriate corrective actions., • Use basic tools and equipment to make minor adjustments or perform routine tasks on the packaging line as required., • Follow gowning procedures and other cleanroom protocols to maintain a controlled and compliant manufacturing environment. Essential Skills • Minimum of 3 years of pharmaceutical packaging experience, including work on packaging lines and in GMP-regulated environments., • High school diploma or equivalent education., • Demonstrated ability to operate vial filling machines, fabrication machines, and secondary packaging equipment, including labeling and semi-automatic packaging systems., • Experience working in a cleanroom or controlled manufacturing environment., • Knowledge and practical application of relevant standard operating procedures (SOPs)., • Basic reading, writing, and verbal communication skills to follow instructions and complete documentation accurately., • Basic mathematical skills for counting, reconciliation, and recording production data., • Basic proficiency in using tools and equipment for routine tasks and minor adjustments on the production line., • Good manual dexterity to handle small components and packaging materials safely and efficiently., • Strong visual acuity to perform inspections and identify quality issues., • Ability to lift or move 25 to 49 pounds as part of regular job duties., • Ability to gown appropriately for manufacturing and adhere to cleanroom requirements. Additional Skills & Qualifications • Experience with general production and packing activities in a manufacturing setting., • Familiarity with GMP documentation practices, including batch records, logbooks, and downtime logs., • Comfort working on pharmaceutical packaging lines, including labeling, inspection, and reconciliation of packaging materials., • Attention to detail and strong focus on accuracy in both production tasks and documentation., • Ability to work effectively on a second-shift schedule and coordinate information across multiple shifts., • Reliability and consistency in meeting production goals and scrap rate targets.Job Type & Location This is a Contract to Hire position based out of Caldwell, NJ. Pay and Benefits The pay range for this position is $20.00 - $24.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 Caldwell,NJ. Application Deadline This position is anticipated to close on Oct 9, 2026. About Aerotek Aerotek® Inc. provides staffing and services solutions in manufacturing, logistics, construction, aviation, facilities and maintenance. We provide the expertise, solutions and people required to rise to the challenges of North American industry. Headquartered in Hanover, Md., Aerotek operates a unified network of over 200 offices across North America, supporting more than 18,000 clients each year. Aerotek is an Allegis Group company, the global leader in workforce and business solutions. To learn more, visit: Aerotek.com | 1-888-AEROTEK. Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

In this role, you will lead Quality Assurance, Quality Control Laboratories, Document Control, Validation, and Complaint Management operations, while overseeing the implementation and continuous improvement of the site Quality Management System in alignment with FDA requirements and corporate standards. You will serve as the site quality lead for FDA and customer inspections, ensuring a constant state of inspection readiness, addressing compliance issues, and managing CAPAs effectively. The position promotes accountability, data integrity, and a right-first-time mindset, and collaborates closely with Operations, Engineering, R&D, and other cross-functional teams on investigations, change management, validations, and continuous improvement initiatives. Responsibilities include supervising batch record review, product release, deviations, and investigations; working directly with customers and stakeholders to meet compliance expectations; and analyzing quality metrics to drive performance and improvement. You will coach and develop a high-performing quality organization, ensure appropriate resourcing, represent site quality leadership in executive meetings, contribute to alignment with corporate quality strategy, and participate in strategic planning and facility expansion discussions. Duties may vary slightly by location. The ideal candidate holds a Bachelor"s degree in Chemistry, Pharmacy, Microbiology, Chemical Engineering, or a related discipline, with an advanced degree preferred, and brings more than 10 years of experience in FDA-regulated OTC, pharmaceutical, or personal care manufacturing environments. This experience includes extensive leadership of FDA inspections and remediation efforts, with additional exposure to aerosol manufacturing and topical formulations considered a strong plus. The role requires expert-level proficiency in cGMPs, 21 CFR Parts 210/211, ICH, and USP requirements, as well as demonstrated success leading FDA and customer audits, maintaining inspection readiness, and developing and verifying effective remediation plans. Candidates must be adept at partnering with Operations, Engineering, and R&D on QMS initiatives, coaching and mentoring teams, and ensuring appropriate quality resourcing. Strong internal and external stakeholder communication skills are essential, along with high proficiency in ERP systems such as SAP, quality platforms such as LIMS or MasterControl, and TrackWise. The successful candidate will have a proven ability to drive transformation in quality mindset and execution across the organization. ASQ certification and Lean Six Sigma or Operational Excellence training are preferred.

Job DescriptionJob Title: Pharmacist In Charge PIC Pharmacy Name: Presidential Pharmacy Location: 121 W Broadway, Paterson, NJ - 07522 Position Type: Full-Time Immediate Start Preferred Company Overview: Presidential Pharmacy is looking for a dedicated and experienced Pharmacist to join our team. We are committed to delivering exceptional patient care and ensuring that our pharmacy operates in full compliance with all relevant laws and regulations. If you are passionate about pharmaceutical care and ready to make a difference, we invite you to apply. Candidates available for immediate start are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide thorough guidance on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure compliance with federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain precise records and responsibly manage controlled substances., • Staff Training: Train and mentor pharmacy staff to uphold best practices., • Collaborative Care: Collaborate with healthcare providers to enhance patient care., • Inventory Management: Monitor and manage inventory levels to avoid shortages or excess., • Insurance Processing: Efficiently handle insurance claims and reimbursements., • Customer Service: Professionally address and resolve patient inquiries and concerns.Job Requirements:, • Required: Valid pharmacist license as per state regulations., • Required: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: 3-5 years of experience in a pharmacy setting.Skills:, • In-depth knowledge of federal and state pharmacy laws and regulations., • Proficiency in pharmacy management software., • Excellent communication and interpersonal abilities., • Strong organizational skills with a keen attention to detail., • Ability to thrive in a fast-paced environment., • Dedication to providing outstanding patient care.Preferred Qualifications:, • Certification in Medication Therapy Management (MTM)., • Experience in inventory management and implementing cost-saving measures., • Proven success in managing a pharmacy team effectively.Benefits:, • 401(k) matching, • Performance-based bonuses, • Competitive salary, • Paid time off, • Opportunities for training and professional development, • Wellness resourcesPerks:, • Competitive Compensation: Attractive salary and benefits packages., • Supportive Environment: Work within a collaborative team that values your contributions., • Career Advancement: Opportunities for growth and development within the organization., • Work-Life Balance: Flexible schedules to support a healthy work-life balance.Why Join Us?, • Supportive Environment: Be part of a team that values your input and fosters your growth., • Growth Opportunities: Advance your career with ample professional development options., • Balanced Schedule: Enjoy a healthy work-life balance with our flexible schedules., • Competitive Packages: Benefit from attractive compensation and growth potential.We look forward to receiving your application! Presidential Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees.

Job DescriptionBenefits: • 401(k), • Competitive salary, • Flexible schedule, • Opportunity for advancement, • Paid time off, • Training & development, • Wellness resources Job Title: Full Time Pharmacist MUST HAVE RETAIL EXPERIENCE Position Type: Full-Time (Immediate Joining Preferred and Available to work weekends) Job Description: Icare Pharmacy Plus is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly., • Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices., • Collaborative Care: Work with healthcare providers to manage and improve patient care., • Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock., • Insurance Processing: Handle insurance claims processing and reimbursement efficiently., • Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements: • Must Have: A valid state required pharmacist license, • Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: • Strong knowledge of federal and state pharmacy laws and regulations., • Proficiency with pharmacy management software systems., • Excellent communication and interpersonal skills., • Ability to work efficiently in a fast-paced environment., • Strong attention to detail and organizational skills., • Commitment to providing exceptional patient care. Preferred Qualifications: • Certification in Medication Therapy Management (MTM)., • Experience with inventory management and cost-saving measures., • Proven track record of effectively managing a pharmacy team. Benefits: • Performance-based bonus, • Competitive salary, • Paid time off, • Training and development opportunities, • Wellness resources Why Join Us: • Supportive Environment: Be part of a team that values and supports your contributions., • Growth Opportunities: Advance your career with opportunities for professional development., • Balanced Schedule: Maintain a healthy work-life balance with our balanced work schedules., • Competitive Packages: Benefit from competitive salary packages and growth opportunities. We look forward to reviewing your application. Icare Pharmacy Plus is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionHuman Resources ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Human Resources Business Partner will provide human resources consultation and support to assigned divisions. Understand business needs in order to assess the human resources implications of various business strategies. Acts as liaison to other functions to ensure achievement of business objectives. Provides staffing and placement support to departments and divisions. Facilitates the recruitment and on-boarding process for all new hires. This position is both operational and strategic in nature and provides HR expertise in the areas of talent management, organization design and effectiveness, performance management, employee relations, employee engagement, compensation, retention and process improvement initiatives. This role will report to the Sr. Director, Human Resources and will serve as a business partner to the Quality Leadership team and function. In addition, this role supports, implements, and executes all tactical aspects of the HR function. • HR Leadership: Coaching, developing and providing guidance to HR team members within assigned groups., • Business Partner: Serving as a true business partner and advisor, gaining the trust of the organization in order to influence and provide effective HR processes, advice and support., • Talent Acquisition: Designing and executing workforce planning and recruitment strategies that attract and retain the best talent in the industry., • Organization Effectiveness: Serves as a change agent in the organization, sponsoring change initiatives in support of organizational evolution., • Employee Relations: Promoting a philosophy of employee relations throughout the company which emphasizes open communications, equal opportunities and treatment, continuous learning and reflects our core values., • HR Expert: Acting as a subject matter expert within the organization and providing interpretation, recommended best practices and ensures compliance with key legal requirements and adherence to company policies and procedures., • Compensation: Ensures our compensation practices continue to attract and reward top talent. Overseeing salary administration to include annual performance management and compensation processes., • Continuous Improvement: Analyzing trends and metrics in partnership with the HR team to draw insights, develop solutions, programs and policies.REQUIREMENTS, • Bachelor’s degree in business, Human Resources or related field., • HR Certification (PHR, SHRM-CP) or ability to obtain certification within one year of employment., • 10 + years progressive HR/business leadership experience is required., • 5+ years in clinical and/or pharmaceutical industry., • Demonstrated ability to build credibility and confidence with a wide variety of employees and leaders as a trusted advisor and confidant., • Ability to influence individuals at all levels of the organization., • Strong problem solving and conflict resolution skills., • Prior experience in working in a matrix and complex operating environment preferred. fast paced, challenging industry., • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance., • Highly ethical, authentic and committed to high integrity., • Learns, fast, while being adaptable to the changing environment., • Looks to raise the bar of service delivery and always seeks ways to address the status quo looking for ways to improve., • Communications proficiency: for both written and verbal communication., • Works collaboratively with all levels of employees., • Works with a composed attitude and behaves accordingly., • Action oriented with results, executes on all assigned goals and objectives., • Must have high level of interpersonal skills to ensure accurate flow of all information.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.SUBMIT: info@lynkxstaffing.com

Job DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. 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, 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., • Manage CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field or equivalent experience., • 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience., • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA, • Must have technical experience writing and assessing deviations, investigations, and Out of Specifications, • Must be able to analyze data/information and to assess and resolve complex problems, • Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing, • Knowledge of operational processes and controls in non-sterile and sterile operations, • 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., • Training; GMP Training, Quality Systems Training (Deviation/CAPA), Safety Training, Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. 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 DescriptionBenefits: • 401(k) matching, • Competitive salary, • Flexible schedule, • Paid time off, • Training & development, • Wellness resources, • Opportunity for advancement Job Title: Pharmacist Pharmacy Name: Sinai Pharmacy Location: 121 W Broadway, Paterson, NJ - 07522 Position Type: Full-Time (Immediate Joining Preferred) Job Description: Sinai Pharmacy is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly., • Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices., • Collaborative Care: Work with healthcare providers to manage and improve patient care., • Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock., • Insurance Processing: Handle insurance claims processing and reimbursement efficiently., • Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements: • Must Have: A valid state required pharmacist license, • Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: • Strong knowledge of federal and state pharmacy laws and regulations., • Proficiency with pharmacy management software systems., • Excellent communication and interpersonal skills., • Ability to work efficiently in a fast-paced environment., • Strong attention to detail and organizational skills., • Commitment to providing exceptional patient care. Preferred Qualifications: • Certification in Medication Therapy Management (MTM)., • Experience with inventory management and cost-saving measures., • Proven track record of effectively managing a pharmacy team. Benefits: • 401(k) matching, • Performance-based bonus, • Competitive salary, • Paid time off, • Training and development opportunities, • Wellness resources We look forward to reviewing your application. Sinai Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description This role is field-based, and candidates should live within a reasonable distance from the primary city. Talent will be hired at a level commensurate with experience. This geography covers the areas surrounding: Manhattan, Bronx, NY and Paramus, NJ. Coordinate commercial activity within in-field teams to ensure targets are reached for increasing sales within an assigned geography. Create, implement, and communicate District Sales Plan and monitor progress. Responsibilities: • Coordinate in-field activity to achieve results and agreed-upon targets. Maximize market, segment, and team dynamics to drive both top- and bottom-line results., • Ensure smooth, collaborative efforts in both day to day and long term business execution. Set tone and pace for business process and organization., • Understand and present a market and franchise/business point of view when leading teams and championing in-field meeting by developing a mastery of product and disease state information, as well as pertinent Market dynamics, including Managed Care landscape., • Coach, mentor, educate and develop direct and indirect team members to enhance individual skills and elevate overall team performance. Hold direct reports accountable to behaviors and expectations., • Provide direction and insights to key internal partners in business planning process. Consistently exemplify the AbbVie Ways of Working.Qualifications, • Bachelor's degree in health, sciences, pharmacy or business-related field preferred or relevant and equivalent industry experience required., • Business analysis and planning skills that drive sales performance., • Proven District Manager leadership to include: In good standing with safety and compliance standards. Minimum four years pharmaceutical sales management experience (external management experience can be considered). Is currently meeting performance expectations. Is living the AbbVie Way and effectively demonstrating the Leadership Attributes., • Excellent judgment and decision making skills. Ability to articulate the scientific aspects of treatments and therapeutic areas, • Proven ability to deliver candid, effective feedback and efficiently manage performance. Ability to develop talent for promotional opportunities., • Ability to create a culture of winning and full team engagement., • An essential requirement of your position is to satisfy all applicable health care industry representative (HCIR) credentialing requirements to gain and maintain entry into facilities and organizations that are in your assigned territory. You must also be in good standing and/or eligible to obtain these credentials., • These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, proof of immunization/vaccination for various diseases, fingerprinting and specific licenses required by individual state or cities. Please remember that you are solely responsible for ensuring that you satisfy all HCIR credentialing requirements and for any associated liability for failing to do so. to AbbVie has resources to answer questions you may have regarding your responsibilities., • Driving a personal auto or company car or truck, or a powered piece of material handling equipment, • Valid driver’s license: Ability to pass a pre-employment drug screening test and meet safe driving requirements. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job Description Overview Amerita, Inc. is a leading provider in home Infusion therapy. We are looking for a Pharmacist to join our Pharmacy team as we grow to be one of the top home infusion providers in the country. The Pharmacist will report to the Pharmacy Manager and work in our City, State branch. Amerita is an entrepreneurial-founded company and a wholly owned subsidiary of PharMerica. The home infusion market is positioned for rapid growth driven by the aging population, increase in chronic diseases, robust pipeline of infusible drugs coming to market, and an industry shift from hospital delivery settings to lower-cost, high-quality alternative providers such as Amerita. As a core member of the Pharmacy team, you will be expected to perform pharmaceutical care activities for customers and patients within the service area. We will help you achieve your goals through continuous professional development and regular career progression discussions. Schedule: Monday - Friday 9:00am - 5:30pm Weekends and on- call rotations required • Competitive Pay, • Health, Dental, Vision & Life Insurance, • Company-Paid Short & Long-Term Disability, • Flexible Schedules & Paid Time Off, • Tuition Reimbursement, • Employee Discount Program & DailyPay, • 401k, • Pet Insurance Responsibilities • Evaluates and monitor drug therapy relative to the total needs of the home care patient in collaboration with physicians, nurses and other healthcare professionals., • Adheres to organization policies and procedures and all applicable state and federal laws and regulations governing pharmacy practice., • Adheres to all appropriate standards of accreditationand participate in quality assurance activities., • Coordinates and facilitate new referrals and admissions through collaboration with nurses, customer service and distribution., • Reviews, receives and verifies all new patient orders and document on the respective order form., • Assists the physician and other involved healthcare professionals with:, • Planning and implementing patient care in the home;, • Setting therapeutic objectives for drug therapy;, • Establishing parameters for monitoring the safety and efficacy of drug therapy; and, • Preparting regular progress reports., • Conducts and document initial and ongoing assessment of specific patient, drug and disease information to identify real and potential drug-related problems or needs., • Monitors the outcomes of drug therapy by collecting, evaluating and interpreting the results of laboratory data, clinical data and other pertinent patient information., • Provides consultation and answer inquiries from patients, families, physicians and other healthcare professionals regarding drugs and their use., • Maintains thorough and appropriate documentation in the customer/patient record of all clinical activities and communication with patients, physicians and other healthcare professionals., • Processes and check all medications, supplies and equipment prior to dispensing from the pharmacy., • Maintains clinical skills and knowledge of pharmacotherapy by reviewing literature and attending in-services, seminars and conferences, • Compounds sterile mixtures and non-mixtures, including, but not limited to parenteral nutrition, antibiotics, chemotherapy, hydration and narcotic analgesics, using aseptic technique where state laws permit, • Ensures compounding/clean room areas and related equipment are cleaned, sanitized and maintained in compliance with company policies and procedures, and USP 797 and USP 800 standards, • Documents all activities on appropriate logs., • Maintains clinical skills and knowledge of pharmacotherapy by reviewing literature and attending in-services, seminars and conferences, • Pharmacists’ duties are extended to include overseeing of the Pharmacy technician functions as required by Pharmacy Board rules Qualifications • Bachelor of Science in Pharmacy required; Doctor of Pharmacy preferred, • Registered Pharmacist License in state(s) of practice, • Minimum of two (2) years of recent experience in an acute-care setting or one (1) year of recent experience in home infusion therapy, • Experience with compounding infused drugs, • Proven record of evaluating and monitoring drug therapies for home care patients, • Good organizational and time-management skills, • Participation and membership in professional societies and organizations is desirable, • Excellent verbal and written communication skills, • Flexible schedule with the ability to work on-call evenings and weekends on an as-scheduled basis Percentage of Travel: 0-25%-Minimal travel may be required To perform this role will required constant sitting and typing on a keyboard with fingers, and occasionally standing, and walking. The physical requirements will be the ability to push/pull and lift/carry 10-30 lbs

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

Job DescriptionABOUT VITALIEF Vitalief is a consulting firm built exclusively for the research and clinical trial industry, providing innovative Consulting and Functional Service Provider (FSP) solutions to academic medical centers, health systems, sponsors, CROs, and site networks. By combining deep subject matter expertise with the experience of senior research practitioners, we help organizations accelerate study activation, optimize operations, improve financial performance, and build scalable workforce solutions that reduce costs, increase efficiency, and advance clinical breakthroughs for patients. POSITION SUMMARY Vitalief is seeking an experienced Clinical Research Coordinator to join our team as a full-time employee with a comprehensive benefits package. This role will support the execution of Phase II–IV oncology interventional clinical trials at a community hospital site in Newark, NJ. This is an excellent opportunity for a Clinical Research Coordinator with 6–12 months of clinical research coordination experience who is looking to expand their expertise in oncology research. The ideal candidate will thrive in a collaborative, small-team environment and contribute to the successful delivery of high-quality clinical trials. WHY VITALIEF? • Meaningful Impact: Support innovative oncology research that advances treatment options and improves patient outcomes., • People-First Culture: Join a collaborative environment focused on professional growth, innovation, and teamwork., • Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability coverage, a 401(k) retirement plan, and comprehensive healthcare benefits., • Work Location: Fully on site in Newark, NJ for the first 3 months. Following training, transition to a hybrid schedule of 4 days onsite and 1 remote day per week., • Schedule: Monday through Friday, 8:00 AM – 4:30 PM., • Salary Range: $55,000 to $60,000 depending on experience. RESPONSIBILITIES • Support the execution of Phase II–IV oncology clinical trials, including pharmaceutical-sponsored, ECOG, and investigator-initiated studies., • Manage trials across multiple oncology disease groups, including GYN, Breast, GI/GU, Head & Neck, and Lung cancers., • Oversee a portfolio of approximately 15–20 active clinical trials in a fast-paced, high-volume clinical environment., • Identify and screen potential study participants using physician schedules, pathology reports, multidisciplinary tumor boards, referrals, and other clinical resources., • Obtain informed consent and enroll eligible patients in accordance with protocol requirements and regulatory standards., • Manage patients throughout the clinical trial lifecycle, from consent through completion of active treatment., • Educate patients regarding study procedures, treatment schedules, and protocol requirements., • Coordinate patient care activities with physicians, infusion teams, nursing staff, radiology, pathology, laboratories, and other clinical departments., • Monitor patient safety, document clinical outcomes, and ensure timely reporting of adverse events and Serious Adverse Events (SAEs)., • Maintain accurate clinical trial documentation, source records, regulatory files, patient calendars, and study-related documentation., • Ensure compliance with study protocols, Good Clinical Practice (GCP), institutional policies, and regulatory requirements. QUALIFICATIONS • Bachelor’s degree in health science, life science, nursing, or a related field., • Minimum of 6 to 12 months of clinical research coordination experience supporting interventional Phase II–IV clinical trials., • Oncology clinical trial experience is a plus (but is not required)., • Experience with patient identification, pre-screening, informed consent, enrollment, retention, regulatory compliance, and clinical data management., • Ability to manage multiple concurrent studies while maintaining strong attention to detail and organization., • Adaptable, solutions-oriented mindset with the ability to work effectively in a small, collaborative team environment., • Strong interpersonal and communication skills with the ability to work closely with physicians, nurses, research staff, hospital departments, and external partners., • Experience ensuring SAEs are documented, completed, and reported within protocol-defined timelines., • Proficiency with Microsoft Office applications., • Proficiency with EPIC and OnCore™ CTMS is a plus. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. 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. Powered by JazzHR lucimeJ8Jj

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. Please Note: The final title for this position will be determined based on the successful candidate's experience, background, and qualifications. The final scope of responsibilities and job description will be confirmed with candidates progressing to the final stage of the interview process. Roles and Responsibilities: • Lead and oversee global post-marketing case processing activities from intake through reporting and case closure., • Develop and maintain pharmacovigilance workflows, procedures, and work instructions as related to post marketing case processing., • Ensure compliance with Good Pharmacovigilance Practices (GVP), FDA requirements, and company SOPs., • Proficient in ICH E2A, E2B(R3), and E2D guidelines, • Proficient in Pharmacovigilance quality systems, • Maintains an extensive understanding of regulations and guidance as they pertain to drug safety and PV, including case processing, narrative and/or safety writing. Understands clinical trial processes., • Independent Project lead, SME; provides strategic narrative development internally and externally, directly negotiates with client., • Process cases independently, understands steps involved with case processing. Leads creation/updates of high-quality deliverables., • Extensive experience working within a safety database and directly interacts with clients. Expert knowledge of coding with MedDRA and WHO drug dictionary., • Proficient in understanding impact of updates in related deliverables, • Independently managing/leading client meetings and CRMs for effective resolutions; provides mentorship to others., • Proficient with managing a project from start to finish and compliant with process; provides mentorship to others; identifies efficiencies within department processes.Requirements:, • College graduate in scientific, medical, clinical discipline or related field, or related experience, masters, PharmD, or PhD preferred., • Minimum of 5 years’ experience in drug safety, pharmacovigilance, or similar field required., • Expert knowledge of scientific principles and concepts., • Expertise in using drug safety databases., • Reputation as emerging leader in field with sustained performance and accomplishment., • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Excellent problem-solving skills., • Good organizational and communication skills., • Familiarity with current ISO 9001 and ISO 27001 standards preferred., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Powered by JazzHR vSu8rI6LkI

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

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

Job DescriptionDescription: RCCA is seeking a highly analytical and detail-oriented Procurement Analyst to support the strategic sourcing, purchasing, and financial performance of oncology pharmaceuticals and specialty medications across a large, multi-site oncology practice. This role focuses on data analysis, market intelligence, supplier performance tracking, and reporting to help ensure reliable drug availability, optimized acquisition costs, strong reimbursement alignment, and operational efficiency. Working closely with the procurement team, pharmacy leadership, finance, revenue cycle, and clinical stakeholders, the Analyst translates complex spend, inventory, and market data into actionable insights that support informed procurement decisions and continuous improvement in the oncology drug supply chain. Employment Type: Full Time Location: Teaneck, NJ Compensation: $85,000 - $120,000 annually Compensation packages based on your unique skills, experience, and qualifications As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities. We believe these benefits underscore our commitment to the well-being and professional growth of our employees. Key Responsibilities Spend Analysis & Cost Optimization • Analyze oncology and specialty drug spend data to identify cost-saving opportunities, pricing variances, and margin improvement potential., • Evaluate purchasing channels (manufacturers, specialty distributors, GPOs, wholesalers, and specialty pharmacies) to support optimal pricing and rebate performance., • Track acquisition costs versus expected reimbursement and flag opportunities to improve buy-and-bill results. Market Intelligence & Supplier Evaluation • Monitor market trends, drug shortages, recalls, biosimilar launches, and new oncology drug approvals., • Conduct research on potential suppliers and evaluate supplier capabilities, reliability, and performance., • Support assessment of biosimilar and alternative therapy opportunities with data-driven recommendations. Contract & Vendor Support • Assist with contract analysis, rebate tracking, and compliance monitoring for pharmaceutical purchasing agreements., • Prepare data packages and performance summaries to support negotiations and annual contract reviews., • Track vendor performance metrics and highlight risks or improvement opportunities. Inventory & Supply Continuity Analytics • Analyze inventory levels, turns, expiration risk, and waste for high-cost oncology medications., • Support shortage monitoring, allocation tracking, and contingency planning with timely data and reporting., • Provide analytical support when clinical teams need alternative product or pathway options during supply disruptions. Reporting & Dashboards • Create and maintain procurement reports and dashboards covering drug spend, cost trends, contract performance, inventory health, and savings initiatives., • Prepare clear summaries and presentations for procurement leadership and cross-functional stakeholders., • Respond to ad-hoc data requests from pharmacy, finance, and operations teams. Cross-Functional Collaboration • Partner with pharmacy, finance, revenue cycle, compliance, and clinical leaders to align procurement activities with operational and financial goals., • Participate in meetings related to formulary considerations, biosimilar adoption, and cost-containment initiatives by providing relevant analysis., • Collaborate with finance to ensure procurement activities remain aligned with budgetary targets. Process Improvement & Technology • Use procurement software, ERP systems, and advanced Excel/analytics tools to streamline data collection and reporting., • Identify opportunities to improve procurement processes, data quality, and reporting efficiency., • Support documentation and audit readiness related to pharmaceutical purchasing and inventory controls. Requirements: Required Qualifications • 2–5 years of experience in procurement analysis, supply chain, healthcare operations, finance, or a related analytical role., • Strong proficiency in Microsoft Excel and experience with data analysis, reporting, or dashboard tools., • Demonstrated ability to analyze large datasets and translate findings into clear, actionable insights., • Excellent attention to detail, organizational skills, and written/verbal communication abilities., • Ability to work collaboratively with clinical, financial, and operational stakeholders. Preferred Qualifications • Bachelor’s degree in Supply Chain Management, Business Administration, Finance, Healthcare Administration, Economics, Operations Research, Statistics, or a related field., • Experience in healthcare, oncology practices, cancer centers, specialty pharmacy, or pharmaceutical purchasing., • Familiarity with oncology drugs, buy-and-bill models, GPOs, biosimilars, or specialty distribution., • Knowledge of healthcare reimbursement concepts, or supply chain risk management., • Experience with procurement or ERP systems commonly used in healthcare settings., • Master’s degree (MBA, MHA, or related) is a plus. Key Skills • Data analysis and interpretation, • Spend and financial analysis, • Market research and supplier evaluation, • Contract and rebate performance tracking, • Inventory and shortage analytics, • Dashboard and report development, • Strong Excel and analytical tool proficiency, • Clear communication of complex information, • Cross-functional collaboration, • Attention to detail and accuracy Working Conditions This position is primarily office-based within a healthcare administrative environment and involves regular interaction with pharmacy, finance, and operations teams. Occasional travel between practice locations or attendance at industry meetings may be required. The role relies heavily on computers, procurement software, ERP systems, and data analytics tools.

Job Description Job Title: Marketing Manager Location: Hoboken, NJ area Type: Full-Time Onsite Compensation: $100,000 – $110,000 Responsibilities • Develop and execute strategic marketing plans and product positioning initiatives, • Support product launches and lifecycle management activities, • Conduct market research, competitor analysis, and identify growth opportunities, • Ensure marketing materials and campaigns align with FDA/industry compliance standards, • Partner with sales teams to create promotional tools, presentations, and training materials, • Analyze campaign performance, market trends, and ROI metrics Requirements, • Bachelor’s degree in Marketing, Business, Healthcare, or related field, • 5+ years of medical device, pharmaceutical, or healthcare marketing experience, • Strong understanding of regulated healthcare/medical device environments, • Experience supporting product launches and commercial strategy initiatives, • Excellent communication, analytical, and project management skills, • Ability to work cross-functionally with leadership, sales, and operational teams System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M- #LI- Ref: #558-Scientific

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

Job DescriptionOur Biotechnology client located in Allendale, NJ is seeking a Human Resources Business Partner who will provide human resources consultation and support to the Quality Department. This position is both operational and strategic in nature and provides HR expertise in the areas of talent management, organization design and effectiveness, performance management, employee relations, employee engagement, compensation, retention and process improvement initiatives. This role reports to the Sr. Director, Human Resources and will serve as a business partner to the Quality Leadership team and function. In addition, this role supports, implements, and executes all tactical aspects of the HR function. • Understand business needs in order to assess the HR implications of various business strategies., • Acts as liaison to other functions to ensure achievement of business objectives., • -Provide staffing and placement support to departments and divisions., • Facilitates the recruitment and on-boarding process for all new hires. HR Leadership: Coaching, developing and providing guidance to HR team members within assigned groups.Business Partner: Serving as a true business partner and advisor, gaining the trust of the organization in order to influence and provide effective HR processes, advice and support.Talent Acquisition: designing and executing workforce planning and recruitment strategies that attract and retain the best talent in the industry.Organization Effectiveness: Serves as a change agent in the organization, sponsoring change initiatives in support of organizational evolution.Employee Relations: Promoting a philosophy of employee relations throughout the company which emphasizes open communications, equal opportunities and treatment, continuous learning and reflects our core values.HR SME: Acting as a subject matter expert within the organization and providing interpretation, recommended best practices and ensures compliance with key legal requirements and adherence to company policies and procedures.Compensation: Ensures our compensation practices continue to attract and reward top talent. Oversee the salary administration to include annual performance management and compensation processes.Continuous Improvement: Analyzing trends and metrics in partnership with the HR team to draw insights, develop solutions, programs and policies. REQUIREMENTS, • -Bachelor’s degree in business, Human Resources or related field., • Minimum of ten years progressive HR/business leadership experience is required., • Demonstrated ability to build credibility and confidence with a wide variety of employees and leaders as a trusted advisor and confidant., • Ability to influence individuals at all levels of the organization., • Strong problem solving and conflict resolution skills., • HR Certification (PHR, SHRM-CP) or ability to obtain certification within one year of employment., • Prior experience in working in a matrix and complex operating environment preferred. Fast paced, challenging industry, • Build strong relationships with peers and cross functionally with partners outside of team to enable higher performance., • Highly ethical, authentic and committed to high integrity., • Learns fast, while being adaptable to the changing environment., • Look to raise the bar of service delivery and always seeks ways to address the status quo looking for ways to improve., • Communication proficiency: for both written and verbal communication, • Work collaboratively with all levels of employees., • Flexibility and adaptable in a high pressured, clinical and/or pharmaceutical environment., • Work with a composed attitude and behaves accordingly., • Action oriented with results, executes on all assigned goals and objectives, • Must have high level of interpersonal skills to ensure accurate flow of all information.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 Pharmaceutical Sales Representative - Primary Care & Specialty (Entry level or Experienced) When you become one of our professional Pharmaceutical Sales Representatives you will act as a lead point of contact for account management activities within your physician accounts. The position is responsible for obtaining and managing profitable business for our product’s by building strong professional relationships based on service, product knowledge, integrity and trust within the accounts. Each Pharmaceutical Sales Rep will develop, manage and execute account business plans that deliver results consistently. Responsibilities for each Pharmaceutical Sales Representative team member: • Coordinate sales and promotion of pharmaceutical / healthcare products within your local territory., • Drive pull-through on existing patients and build awareness of product portfolio with each physician., • Build strategic customer relationships at general practices, hospitals, and specialty clinics to foster a long-term professional relationship based on service, product knowledge, integrity and trust, and favorably position for future product launches., • Develop strategies, tactics, marketing initiatives, and sales programs as applicable to scope., • Plan and organize sales calls in the territory for effective use of time and economic considerations to optimize performance goals within each account., • Maintain knowledge of product/service, market/industry trends, regulatory changes, competitors, and customers and communicate to management in real-time., • Complete all industry pharmaceutical sales training plus maintain CME education to keep up to date on innovative products to successful detail physicians., • Review and analyze contracted product performance within accounts and take and/or evolve actions as appropriate (monitor contracts, plan execution, value, volume growth, market share, etc.), • Develop a strong alliance with the Pharmaceutical Sales Representative team to ensure the appropriate level of cross-functional support and communication to develop and execute effective pull-through strategies., • Strictly adhere to relevant pharmaceutical sales rep regulatory and compliance guidelines and company policies. Requirements • Minimum Requirements for the Pharmaceutical Sales Rep opportunity:, • Sales abilities with inter-personal skills, knowledge of account management and/or sales experience., • This position will be field based and will require a valid drivers license., • Computer literacy (i.e., Word, Excel, and PowerPoint) is a must., • Must have the ability to differentiate yourself in the marketplace., • Excellent organizational/communication skills, self-starter and ambition to succeed. Benefits • Health Care Plan (Medical, Dental & Vision), • Retirement Plan (401k, IRA), • Paid Time Off (Vacation, Sick & Public Holidays), • Family Leave (Maternity, Paternity) Apply today with your resume. Pharmaceutical Sales Rep openings are immediate and interviews will be taking place for all qualified applicants. As an equal opportunity employer we will consider all qualified pharmaceutical sales rep applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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 DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.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 Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a energy and utility company in Newark, NJ. This is a Hybrid role see details below. This role will be onsite and available to candidates local to the Newark, NJ area. We are interested in every qualified candidate who is eligible to work in the United States. Unfortunately, we are not able to sponsor visas or employ corp-to-corp Business Development Manager - Energy Efficiency Program Support Manager Location: Hybrid – Newark, NJ - 1 day per week Supporting Clients in Central and South New Jersey 12 Month Contract Pay Rate: $60-$65/hr w2 Mileage Reimbursement Job Summary Oversee the performance of vendor(s), both office and field, that have been contracted to deliver program services Ensure vendor and employee compliance with safety protocols and practices Lead and participate in cross-functional teams, including other RES members, Customer Care, Contracting, Procurement, Legal, Marketing, IT etc, as required to deliver program services Enhance program delivery/customer experience and resolve business/customer issues Develop and maintain the processes for implementing energy efficiency projects and programs in accordance with requirements for BPU approved programs Provide oversight for business controls, process improvement and compliance Ensure accurate invoice processing Identify and implement process improvements and automate where possible Monitor program Key Performance Indicators to ensure program delivery meets business plan expectations Prepare and present program and project status reports to senior management Assist with special projects as necessary This leader must foster an inclusive work environment and respect all aspects of diversity. Must demonstrate and value differences in others' strengths, perspectives, approaches, and personal choices During storm restoration efforts, may be required to perform functions outside of routine duties and on a schedule that may be different from normal operation Job Responsibilities Oversee the performance of vendor(s), both office and field, that have been contracted to deliver program services; manage employee performance; ensure safety protocols and practices are followed. Lead and participate in cross-functional teams, including other RES members, Customer Care, Contracting, Procurement, Legal, Marketing, IT etc, as required to deliver program services, enhance program delivery/customer experience and resolve business issues. Develop and maintain program processes. Provide oversight for business controls, process improvement and compliance. Ensure accurate invoice processing. Identify and implement process improvements and automate where possible. Monitor program Key Performance Indicators to ensure program delivery meets business plan expectations and regulatory requirements; Prepare and present program and project status reports to senior management. Required: B.S. Degree in Management, Engineering, Business, Finance or other relevant field or equivalent work experience plus 7 years of experience in the space of energy efficiency programs, construction, or related fields. In lieu of a degree, 11 years of experience in the space of energy efficiency programs, construction, or related field. Experience managing vendor performance, and leading cross-functional teams; Energy Efficiency or Electric Vehicle program experience Management/leadership experience working with cross-functional teams Valid US driver's license Desired: Certified Energy Manager (CEM) certification MBA or Advanced Degree \nCompany Description A WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide. A WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.

Job DescriptionDescription: RCCA is seeking a dynamic Regulatory Coordinator Assistant to join our team! This vital role is responsible for handling all regulatory documents and applications essential for launching new clinical trials. As our Regulatory Coordinator Associate, you will submit continuations and amendments, address inquiries, generate detailed reports, and maintain comprehensive research files and documentation to ensure compliance with regulatory requirements for studies and clinical trials. You'll play a key role in ensuring adherence to all federal and local regulations, including those set forth by the Food and Drug Administration (FDA) and the local Institutional Review Board (IRB). Additionally, you'll represent RCCA in meetings with pharmaceutical companies, actively participate in team meetings, and collaborate with fellow staff members to ensure all regulatory documents and requirements are consistently met and updated. Join us in making a meaningful impact in clinical research and compliance, while fostering strong relationships with industry partners! Employment Type: Full Time Location: Teaneck, NJ Compensation: $27.09 - $36.54 per hour Compensation packages based on your unique skills, experience, and qualifications As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities. We believe these benefits underscore our commitment to the well-being and professional growth of our employees. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Prepare, compile, update, and submit regulatory documents from start to finish. This includes the study feasibility questionnaire, start-up application, Investigator Brochures, Protocol/Amendments, Informed Consent Form/Amendments, IRB start-up/renewal/termination, SAE Report, Protocol Deviations, and SUSARs to the Sponsor, IRBs and other regulatory bodies., • Address all inquiries from the RCCA clinical trial team, Sponsor, IRBs and other regulatory bodies related to the study's regulatory aspects., • Complete forms and generate all necessary reports to ensure compliance with regulatory requirements and RCCA institutional policies., • Establish and maintain electronic and paper documentation, including Investigator Site Files (ISF)/regulatory binders, and other documentation relevant to regulatory requirements for clinical trials., • Schedule and coordinate site initiation visits, interim monitoring visits, and close-out visits with the Sponsor and the RCCA clinical trial team., • Generate the necessary regulatory documentation for study start-up, site initiation visits, routine monitoring visits, and close-out visits. Maintenance of Monitor Tracking Log., • Collect, track, and maintain all regulatory documents, including Delegation of Authority (DOA) Logs, Training Logs (GCP, CV, IATA), medical licenses, malpractice insurance, lab licenses, pharmacy licenses, protocols, ICF, Investigator’s Brochure (IB), Pharmacy Manual, Lab Manual, Radiology Manual, Temperature Logs, DARF, Study Kits Log, and Calibration Logs, ensuring that all documents for the research studies are compliance with ICH-GCP, FDA Compliance., • Periodically review Source Documents, Case Report Forms (CRFs), Study Documents, Logs, and Master Files with coordinators and staff to ensure quality, completeness, and accuracy. Issue queries for all reviewed documentation and investigate any systemic issues and report feedback to clinical trial management., • Review monitor follow-up letters and ensure that any outstanding issues are addressed., • Participate in required clinical trial meetings, training sessions, and educational huddles., • Responsible for in-house and offsite archiving and retention of regulatory documentation, ensuring that everything is organized and easily accessible.Requirements:, • High School Diploma required; Associate degree preferred., • A minimum of 1 year of experience in clinical trials, regulatory affairs, or an oncology-related field is required. Specialized Knowledge/Skills: • Knowledge of GCP, ICH, FDA, and EMA regulations., • Strong familiarity with eRegulatory systems, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), OncoEMR, MS Word, PowerPoint, Excel, PDF, internet applications, MS Teams, Zoom, and Google Meet., • Ability to work in a fast-paced environment with a high level of attention to detail, strong multitasking capabilities, and excellent communication skills. Working Conditions: The position is typically based in a traditional outpatient clinic or office environment. Monday to Friday from 8am to 5pm. Ability to travel within RCCA network when required. The working conditions described are representative of those an employee may encounter while fulfilling the essential functions of the job. Reasonable accommodation may be made for individuals with disabilities. Employees may be exposed to communicable diseases, toxic substances, ionizing radiation, medical preparations, and other conditions common to an oncology/hematology clinic environment. Physical Requirements: • A significant portion of the work involves computer-based tasks. The physical demands outlined here represent those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made for individuals with disabilities., • The job requires standing and walking for extended periods and occasionally lifting and carrying items weighing up to 40 lbs. Employees must have corrected vision and hearing within a normal range.

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

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

Job Description Job Title: Aseptic Technician – 2nd Shift Job Description The Aseptic Technician plays a key role in supporting sterilization operations within ISO 6 and ISO 7 cleanroom environments. This position focuses on washing glassware and medical components, performing aseptic cleaning and sterilization tasks, maintaining aseptic samples, and monitoring process systems and equipment to ensure proper operation. The role requires adherence to GMP and SOP guidelines, accurate documentation, and active participation in safety and quality practices on a consistent basis. Responsibilities • Wash glassware and medical components using designated equipment in accordance with established procedures., • Work in ISO 6 and ISO 7 cleanroom environments while wearing all required personal protective equipment (PPE)., • Perform aseptic cleaning and sterilization activities to support pharmaceutical, medical device, and biotech operations., • Maintain aseptic samples and ensure they are handled and stored according to GMP and SOP requirements., • Monitor process systems and equipment to verify proper operation and promptly report any deviations., • Perform daily and weekly preventative maintenance tasks on equipment and assist the maintenance team as needed., • Participate in safety committees and strictly adhere to all safety rules, procedures, and regulations., • Accurately complete all required documentation, including batch records, reviews, and other GMP-related forms., • Clean, sanitize, and disinfect workstations before and after use to maintain a sterile and orderly environment., • Demonstrate strong attention to detail and maintain high accuracy in all work performed., • Perform additional tasks as assigned by the supervisor to support ongoing operations and projects., • Adapt to different processes and workflows depending on the project requirements. Essential Skills • 1–2 years of industry experience in aseptic processing, sterile processing, pharmaceutical, or related GMP environments is ideal., • Hands-on experience working in cleanroom or laboratory environments with aseptic techniques., • Strong knowledge of GMP principles and the ability to follow SOPs consistently., • Experience with aseptic cleaning, sterilization, and aseptic technique in operational settings., • Ability to handle, review, and maintain batch records in alignment with good documentation practices., • Basic computer skills to work within internal databases and electronic documentation systems., • Proven punctuality, flexibility, and strong work ethic in a production or laboratory environment., • Ability to wear required PPE and gown for extended periods while maintaining compliance with cleanroom protocols. Additional Skills & Qualifications • Experience in pharmaceutical, compound pharmacy, medical device, biotech, or related GMP industry., • Experience in cleanroom operations and sterile processing environments., • Familiarity with operation of sterilization equipment and process systems., • Commitment to long-term growth and development within the organization., • Strong attention to detail and accuracy in both technical tasks and documentation., • Comfort working with a home-grown internal database and learning new systems., • Ability to collaborate effectively with safety committees and cross-functional teams. Work Environment • This role is based in ISO level 6 and 7 cleanroom environments focused on steam and dry heat sterilization for pharmaceutical, medical device, and biotech applications., • The position requires gowning and wearing full PPE for 6–10 hours at a time, with scheduled breaks provided during the shift., • The standard schedule is 2nd shift, Monday through Friday, from 2:00 p.m. to 10:30 p.m., • The facility emphasizes strict GMP compliance, SOP adherence, and robust safety practices., • The work setting offers lab expansion and growth potential, providing opportunities to develop skills and advance within a highly regulated and quality-driven environment.Job Type & Location This is a Contract to Hire position based out of Clifton, NJ. Pay and Benefits The pay range for this position is $23.00 - $24.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 Clifton,NJ. Application Deadline This position is anticipated to close on Sep 25, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law. If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records. Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.

Job Description Overview Amerita, Inc. is a leading provider in home Infusion therapy. We are looking for a Pharmacy Technician - Production to join our Pharmacy team as we grow to be one of the top home infusion providers in the country. The Pharmacy Technician will report to the Pharmacy Manager and work in our City, State branch. Amerita is an entrepreneurial-founded company and a wholly owned subsidiary of PharMerica. The home infusion market is positioned for rapid growth driven by the aging population, increase in chronic diseases, robust pipeline of infusible drugs coming to market, and an industry shift from hospital delivery settings to lower-cost, high-quality alternative providers such as Amerita. As a core member of the Pharmacy team, you will be expected to prepare technical and clerical tasks associated with the preparation, labeling and dispensing of pharmaceuticals. We will help you achieve your goals through continuous professional development and regular career progression discussions. Schedule: Monday - Friday 10a-6:30p NJ Active Pharm Tech Licenses are required. • Competitive Pay, • Health, Dental, Vision & Life Insurance, • Company-Paid Short & Long-Term Disability, • Flexible Schedules & Paid Time Off, • Tuition Reimbursement, • Employee Discount Program & DailyPay, • 401k, • Pet Insurance Responsibilities • Helps coordinate patient care activities with Pharmacists, Nurses, access team, and other Technicians, • Prepares labels, prescriptions and compounding/mixing worksheets and completes and maintains product lot numbers, expiration dates and batch records, • Documents all temperature logs, pressure and humidity monitors, records all sterility testing done in the clean room in compliance with company policies and procedures, and USP 797 and USP 800 standards. Documents all activities on the appropriate logs, • Participates in branch management, department and intra-departmental meetings and quality improvement activities, • Coordinates and schedules the preparation of sterile mixtures and home medical equipment orders with the assistance of the Pharmacist, • Adheres to all accreditation, OSHA, FDA, state, local and federal regulations and standards relevant to infusion pharmacy and home medical equipment, • Other duties as assigned, • Supervisory Responsibility: No Qualifications • Successful completion of an approved/accredited Pharmacy Technician training program; IV certification preferred, • Registered Pharmacy Technician license in state of practice per state regulations, • National Pharmacy Technician Certification as required by the state board of pharmacy in state of practice, • 1-3 years of related pharmacy experience in a home care setting, • At least 1 year of aseptic preparation of infusion-related pharmaceuticals in a hospital or home infusion setting, • General knowledge of drug terminology, pharmaceutical calculations, drug use and aseptic techniques, • Effective mathematical and communication skills required, • Basic pharmacy knowledge of reading and interpreting prescriptions, • Ability to work independently, accurately and efficiently, • Valid driver's license Driving Position: Yes-Minimal driving for patient deliveries may be required To perform this role will require constant sitting, and typing on a keyboard with fingers, and occasional standing, and walking. The physical requirements will be the ability to push/pull and lift/carry 10-30 lbs

Job 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 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., • As needed and required perform other tasks and functions. Supervisory Responsibility: • Provide advice, professional development, and conduct performance management with cross-functional groups if applicable. Qualifications: • 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, • Team player, flexible, ability to adapt to change Education and/or Experience: • 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, • Must have oncology and rare disease experience, • Strong leadership abilities and proven abilities to lead a team within a matrix organization as well as able to work independently and be proactive. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $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, • Career Development, Progression and Training, • Flexible Work Arrangement Programs, • Paid Parental Leave, • Year-End Paid Holiday Shutdown Applications will be accepted until October 1, 2026 or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We’re exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan Summary: CMC Regulatory Affairs develops and executes CMC regulatory strategies for investigational and marketed products in close collaboration with regulatory leadership, with a primary focus on U.S. Health Authority (FDA) interactions. This role coordinates and oversees the preparation and review of CMC-related regulatory documents, supports Health Authority meetings and follow-up commitments, and partners closely with cross-functional teams in the U.S. (NS Pharma) and Japan (Nippon Shinyaku HQ) to ensure global alignment and timely issue resolution. This is a hybrid role that requires two days in the Paramus, NJ office. Responsibilities: • Plan and execute CMC regulatory activities including IND M3/IMPD-Quality for investigational products, and NDAs/BLAs and post-approval supplements/variations for marketed products., • Lead and coordinate CMC-related FDA meetings (e.g., pre-IND; Type A, B, and C; and NDA/BLA-related meetings) in collaboration with Regulatory Affairs Strategy, including meeting strategy, material preparation, internal alignment, and submission logistics., • Coordinate and oversee CMC dossier readiness and the preparation/review of CMC regulatory deliverables in eCTD format, including scientific/technical input for full regulatory compliance., • Serve as the day-to-day CMC regulatory liaison for timely submission-ready of CMC-document through IND/CTA/NDA/BLA., • Coordinate and support responses to CMC-related Health Authority information requests/questions in alignment with cross-functional stakeholders., • Manage external CMC regulatory expert consultations (consultants/contractors) including selection support, deliverable expectations, quality review, and timeline/budget oversight., • Partner with cross-functional teams (CMC, QA, Clinical, Nonclinical, Project Management, etc.) to align regulatory strategy and execution., • Establish regulatory classification and filing strategy for CMC changes in manufacturing, analytical testing, and supply chain throughout the product life cycle., • Ensure consistency and traceability of CMC regulatory positions across key documents (e.g., Module 2 QoS and Module 3 content)., • Maintain CMC regulatory documentation controls and inspection/audit readiness (e.g., version control, document traceability, decision logs, and submission trackers) to support timely, high-quality deliverables., • Monitor and communicate evolving global regulatory requirements and guidance (e.g., ICH, FDA, EU), and proactively assess impacts and risks, and take required actions for programs., • Support operational regulatory activities as needed, including coordination of cross-functional meetings, maintenance of submission trackers, and documentation of decisions and action items. Experience (Required): • Strong knowledge of U.S. FDA CMC regulatory requirements., • Strong knowledge of ICH Quality guidelines, • Excellent English communication skills (written and verbal) suitable for Health Authority interactions and regulatory documentation., • Working knowledge of CMC CTD/eCTD structure and the ability to ensure CMC content readiness and consistency., • Experience working effectively in a cross-functional team environment. Preferred Qualifications: • Strong knowledge of GMP, • Experience in rare disease, • Working understanding of EU regulatory requirements (EMA) and ability to support EU-related activities., • Demonstrated ability to develop and execute CMC regulatory strategy throughout the product lifecycle., • Excellent technical writing and editing skills for regulatory documentation and Health Authority correspondence (clear, consistent, defensible rationale)., • Strong organizational and project management skills, including prioritization, issue/risk tracking, attention to detail, and document control discipline (version control, traceability, decision documentation). Education: • A bachelor’s degree in pharmacy, chemistry, or a related scientific discipline, or equivalent experience is required. MSc or PhD preferred., • Typically, 8 – 10 years of experience in the CMC field of the pharmaceutical/biotechnology industry, including a minimum of 5 years of CMC regulatory affairs., • A minimum of one NDA/BLA and multiple IND/CTA is also preferred. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $170,000 to $190,000; 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, • Career Development, Progression and Training, • Flexible Work Arrangement Programs, • Paid Parental Leave, • Year-End Paid Holiday Shutdown Applications will be accepted until August 31, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Job Description 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 This is an individual contributor role that supports the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH, local Regulatory requirements and NS Pharma standard operating procedures. This is a hybrid position that requires to travel to the Paramus, NJ office at least twice a week. Essential Duties and Responsibilities • Assist in the planning, implementation and management of assigned regional or global clinical studies., • Facilitate CRO./vendor selection process., • Maintain oversight of assigned study vendors (e.g. central labs)., • Perform assigned activities in the selection of clinical sites., • Attend and participate in site visits including pre-study assessments, site initiations, co-monitoring and ad-hoc site visits based on the study’s needs., • Review site visit reports, identify issues and ensure issues are resolved., • Oversight of patient recruitment and development of recruitment strategies and plans., • Track, review, report and present study metrics including enrollment, protocol deviations, issues, risks, data resolution, and other study related metrics., • Support the development of study related documentation (protocol, ICF, CRF, operations manuals, etc.); facilitate internal review of these documents as assigned., • Tracking of clinical data, regulatory documents, and patient, • Assure compliance of investigational sites with SOPs, FDA regulations, ICH guidelines and protocol requirements., • Facilitate internal review of clinical trial agreements and ancillary agreements.., • Implement and maintain study-specific training program., • TMF oversight review during study conduct and TMF management during study closeout., • Support creating and maintaining clinical SOPs as part of global QMS., • Perform administrative tasks (e.g. setting-up and facilitating meetings, clinical registrations)., • Perform other tasks and functions as needed. Qualifications • Thorough understanding of clinical operations including strong knowledge on essential documents as related to the planning, launching, and closing clinical studies., • Must be able to manage and coordinate with the Clinical Lead(s), Study Manager(s), Operations Program Lead and study team members at Headquarters Office in Japan to achieve study objectives and team goals., • Must have the ability to identify and manage/solve study team’s performance issues if they arise with minimal supervision., • Must have demonstrated ability to support the development and management of various aspects of the study operational plans from start-up to close-out., • Must be able to work effectively in a multi-cultural, global team environment and support drug development collaboration with global project teams, Headquarters Office in Japan, external partners and vendors., • Ability to handle multiple tasks and prioritize., • Strong organizational, attention to details, communication and presentation skills., • Team player, flexible, ability to adapt to change., • Ability to interact with Investigators in-person to discuss protocol requirements and study drug., • Ability to travel 15-25% monthly within the US and/or outside of US. Education and/or Experience • Bachelor’s Degree in sciences (highly preferred) or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience, • Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials., • Program and project management experience preferred., • Global clinical trial experience is also preferred., • Rare Disease experience highly preferred Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $120,000 to $130,000; 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, • Career Development, Progression and Training, • Flexible Work Arrangement Programs, • Paid Parental Leave, • Year-End Paid Holiday Shutdown Applications will be accepted until December 1, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Job DescriptionDescription:Associated Fire Protection is seeking a highly motivated and experienced Fire Alarm Technician to join our team. The ideal candidate will have extensive experience installing, maintaining, repairing, testing, and troubleshooting fire alarm systems, with the ability to work in both NJ and NYC locations. About Us Associated Fire Protection, founded in 1947, is a leader in fire protection and life safety. We have offices located through New Jersey and New York. We are seeking motivated individuals to join our growing team. While previous experience in fire protection is a plus, we are also looking for people looking to make a change to an industry that is dedicated to protecting lives and property. We are very passionate about our work, but understand that our family, friends and other interests play an important role in our lives. If you are thinking about making a change, give us a shout. General Description: Supports the company by performing installations, testing, repair, inspection and maintenance of fire alarm protection systems and equipment. Essential Functions- including but not limited to: • Perform installation, testing, repair, inspections, troubleshooting and programming as applicable, on fire alarm systems and equipment in compliance with electrical and fire safety codes., • Ensure systems are functioning correctly and address any issues that arise., • Ensure that all systems meet local and national fire safety regulations., • Complete inspection reports and repair work orders via mobile device and submit them on a timely basis., • Ability to read blueprints., • Pull materials for jobs as required., • Maintain truck inventory when applicable., • Communicate with customers review work and answer any service, quality or technical questions., • Other job specific functions may be required depending on level., • Serve on the on-call emergency service rotation. General Functions • This position includes a lot of interaction with customers and coworkers. The successful candidate must be able to communicate effectively and enjoy collaboration with others, • The successful candidate should read and be aligned with company’s mission statement, vision and values., • Depending on skill level, the successful candidate must be able to manage, lead and mentor people. Benefits Offered • This position offers benefits including Medical Care, Dental Care, and Vision Care., • Competitive pay., • Paid time off (PTO) and sick leave., • Supplemental Life and Supplemental Insurance., • Flexible spending (FSA), medical, dependent care (DCA), and commuter benefits., • 401k. Requirements: Qualifications, Experience and Education- including but not limited to: • Must have experience in Fire Alarms, preferably minimum 5 years., • Adhere to all safety policies and procedures., • Experience working with Fire Alarm systems and equipment is required., • Experience working on fire protection systems and equipment is required., • NICET certifications preferred., • S98/S97 preferred and will be required., • OSHA 30 preferred., • Capable of performing physical labor to include carrying and moving equipment and tools up to 50-70 lbs. Able to work in unusual and sometimes difficult position such as climbing ladders, scaffolding and high lift equipment up to 40 feet, working within ducts, crawl spaces, above ceilings, etc., • Must be able to obtain any licenses or certifications as required in the area that you are working., • Experience working with fire protection and suppression systems is required., • Perform simple tasks independently., • Excellent customer service skills., • Computer, phone and tablet literate., • Well organized, self-motivated, flexible and a team player., • Must be able to drive to and from jobs and have a valid driver's license., • Must be able to work flexible hours and overtime as needed., • Emergency Service shifts are a requirement for this job. Qualified candidates must be able to respond to NY emergency service calls. Work Conditions The physical efforts and working conditions are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the position, and the work environment characteristics that may encounter. This is not all inclusive and subject to change at any time. • Daily schedule may consist of work to be performed on various job sites. May be required to work outside., • May be required to work at various heights and on lifts., • Frequently works with others and has customer/public contact, occasionally works alone., • The physical requirements are described as medium to heavy, • While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vehicles., • The employee is often required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl., • Job sites may include construction sites and other locations where personal protective equipment will be required., • Job sites may include confined spaces., • The position has frequent periods of stress., • Job sites may include schools, hospitals, jails, pharmaceutical companies and other companies that may require additional background checks and medical and drug screens.DISCLAIMER: The physical efforts and working conditions are not limited to those listed in this job posting and may change at any time. Reasonable accommodation(s) may be made to enable individuals with disabilities to perform the described essential functions of the position. Associated Fire Protection is an Equal Opportunity and Affirmative Action Employer, including disability.

Job DescriptionRegulatory Affairs Manager Location: Totowa, NJ (Onsite) Employment Type: Full-Time | Exempt Department: Regulatory Affairs Reports To: Global Chief of Quality (GCQO) Position Summary The Regulatory Affairs Manager is responsible for leading site regulatory operations while ensuring alignment with global regulatory strategy and corporate quality standards. This role oversees regulatory compliance, submissions, facility registrations, and cross-functional coordination to ensure full adherence to applicable global regulations. The position serves as the primary regulatory lead for operational execution at the site and ensures effective communication between site operations and global quality leadership. Key Responsibilities • Lead preparation, coordination, and response activities for regulatory inspections, cGMP audits, and environmental audits., • Own the development, review, and maintenance of Product Master Files (Dossiers), Drug Master Files (DMFs), and global regulatory submissions., • Review and approve compliance documentation (CoCs, CoAs, CoMs, BSE, CMR, SDS, RM documentation, etc.) for domestic and international requirements., • Oversee issuance of Raw Material regulatory statements, including Origin, REACH, Allergen, Nitrosamine-Free, EU/China compliance, and other global declarations., • Lead regulatory submissions related to Organic (USDA/Ecocert), Gluten-Free, MoCRA, CARES Act reporting, and other regulatory programs., • Direct vendor communication and ensure timely collection and verification of regulatory documentation., • Oversee regulatory compliance documentation generated through internal and third-party systems., • Conduct regulatory reviews of formulas and ingredients to ensure compliance across all intended markets; proactively identify regulatory risks and implement mitigation plans., • Lead product and facility registrations and serve as the primary contact for regulatory agency correspondence., • Ensure ongoing compliance with FDA (21 CFR 210/211/820), EPA, OSHA, Health Canada, ISO, EU, China CSAR, Japan, and other applicable global regulations., • Oversee regulatory-related SOP development, Change Control, and Quality Management System (QMS) compliance., • Monitor evolving global regulatory requirements and implement necessary updates to maintain compliance., • Provide regulatory leadership and guidance to cross-functional teams while supporting global quality initiatives., • Review OTC Drug Listings and OTC Artwork.Qualifications, • Bachelor's degree in Life Sciences, Engineering, or a related field (Advanced degree preferred)., • Minimum 7 years of regulatory experience in the pharmaceutical, cosmetic, medical device, or other regulated industries., • Strong working knowledge of FDA regulations (21 CFR Parts 210 & 211)., • Demonstrated experience leading regulatory audits and global regulatory submissions., • Experience working within global or matrix organizations is preferred., • Strong leadership, communication, and cross-functional collaboration skills., • Strong analytical thinking and regulatory risk assessment capabilities.Work Schedule, • Onsite position based in Totowa, New Jersey., • Monday through Friday, Full-Time., • Additional hours may be required to support audits, inspections, regulatory submissions, and business needs.Compensation $90,000 - $120,000 annually Actual compensation will be determined based on experience, qualifications, skills, and internal equity. This position is also eligible for the company's discretionary bonus program. Benefits • Medical, Dental & Vision Insurance, • Company-paid Life, AD&D and Disability Insurance, • 401(k) with Company Match, • Paid Time Off (PTO), • Paid Company Holidays, • Special Paid Leave for Personal Events, • Employee Referral Program, • Year-End Gift, • Additional benefits as outlined in the Employee HandbookEqual Opportunity Employer Englewood Lab, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, pregnancy, veteran status, or any other characteristic protected by applicable federal, state, or local law. Englewood Lab provides reasonable accommodations to qualified individuals with disabilities in accordance with applicable law. Powered by JazzHR BjjOmzsS0W

Job DescriptionDescription:Associated Fire Protection is seeking a highly motivated and experienced Fire Protection Sprinkler Technician to join our team. The ideal candidate will have extensive experience installing, maintaining, repairing, testing, fire protection sprinkler systems and equipment, with the ability to work in both NJ and NYC locations. About Us Associated Fire Protection, founded in 1947, is a leader in fire protection and life safety. We have offices located through New Jersey and New York. We are seeking motivated individuals to join our growing team. While previous experience in fire protection is a plus, we are also looking for people looking to make a change to an industry that is dedicated to protecting lives and property. We are very passionate about our work, but understand that our family, friends and other interests play an important role in our lives. If you are thinking about making a change, give us a shout. General Description: Supports the company by performing installations, testing, repair, inspection and maintenance of fire protection systems and equipment. Essential Functions- including but not limited to: • Perform installation, testing, repair, inspections, and maintenance on fire suppression systems and equipment in compliance with fire safety codes., • Ensure systems are functioning correctly and address any issues that arise., • Ensure that all systems meet local and national fire safety regulations., • Complete inspection reports and repair work orders via mobile device and submit them on a timely basis., • Ability to read blueprints., • Pull materials for jobs as required., • Maintain truck inventory when applicable., • Communicate with customers review work and answer any service, quality or technical questions., • Other job specific functions may be required depending on level., • Serve on the on-call emergency service rotation. General Functions • This position includes a lot of interaction with customers and coworkers. The successful candidate must be able to communicate effectively and enjoy collaboration with others, • The successful candidate should read and be aligned with company’s mission statement, vision and values., • Depending on skill level, the successful candidate must be able to manage, lead and mentor people. Benefits Offered • This position offers benefits including Medical Care, Dental Care, and Vision Care., • Competitive pay., • Paid time off (PTO) and sick leave., • Supplemental Life and Supplemental Insurance., • Flexible spending (FSA), medical, dependent care (DCA), and commuter benefits., • 401k. Requirements: Qualifications, Experience and Education- including but not limited to: • Adhere to all safety policies and procedures., • Experience working on fire protection systems and equipment is required., • NICET certifications preferred., • S12-S13 preferred and may be required., • OSHA 30 preferred., • Capable of performing physical labor to include carrying and moving equipment and tools up to 50-70 lbs. Able to work in unusual and sometimes difficult position such as climbing ladders, scaffolding and high lift equipment up to 40 feet, working within ducts, crawl spaces, above ceilings, etc., • Must be able to obtain any licenses or certifications as required in the area that you are working., • Perform simple tasks independently., • Excellent customer service skills., • Computer, phone and tablet literate., • Well organized, self-motivated, flexible and a team player., • Must be able to drive to and from jobs and have a valid driver's license., • Must be able to work flexible hours and overtime as needed., • Emergency Service shifts are a requirement for this job. Qualified candidates must be able to respond to NY emergency service calls. Work Conditions The physical efforts and working conditions are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the position, and the work environment characteristics that may encounter. This is not all inclusive and subject to change at any time. • Daily schedule may consist of work to be performed on various job sites. May be required to work outside., • May be required to work at various heights and on lifts., • Frequently works with others and has customer/public contact, occasionally works alone., • The physical requirements are described as medium to heavy, • While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vehicles., • The employee is often required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl., • Job sites may include construction sites and other locations where personal protective equipment will be required., • Job sites may include confined spaces., • The position has frequent periods of stress., • Job sites may include schools, hospitals, jails, pharmaceutical companies and other companies that may require additional background checks and medical and drug screens.DISCLAIMER: The physical efforts and working conditions are not limited to those listed in this job posting and may change at any time. Reasonable accommodation(s) may be made to enable individuals with disabilities to perform the described essential functions of the position. Additionally, the various job functions and requirements are not limited to the items listed here. Associated Fire Protection is an Equal Opportunity and Affirmative Action Employer, including disability.

Job DescriptionBenefits: • Paid time off, • Competitive salary Job Title: PHARMACIST IN CHARGE MUST HAVE RETAIL EXPERIENCE Position Type: Full-Time (Immediate Joining Preferred and Available to work weekends) Job Description: Icare Pharmacy Plus is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly., • Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices., • Collaborative Care: Work with healthcare providers to manage and improve patient care., • Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock., • Insurance Processing: Handle insurance claims processing and reimbursement efficiently., • Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements: • Must Have: A valid state required pharmacist license, • Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: • Strong knowledge of federal and state pharmacy laws and regulations., • Proficiency with pharmacy management software systems., • Excellent communication and interpersonal skills., • Ability to work efficiently in a fast-paced environment., • Strong attention to detail and organizational skills., • Commitment to providing exceptional patient care. Preferred Qualifications: • Certification in Medication Therapy Management (MTM)., • Experience with inventory management and cost-saving measures., • Proven track record of effectively managing a pharmacy team. Benefits: • Performance-based bonus, • Competitive salary, • Paid time off, • Training and development opportunities, • Wellness resources Why Join Us: • Supportive Environment: Be part of a team that values and supports your contributions., • Growth Opportunities: Advance your career with opportunities for professional development., • Balanced Schedule: Maintain a healthy work-life balance with our balanced work schedules., • Competitive Packages: Benefit from competitive salary packages and growth opportunities. We look forward to reviewing your application. Icare Pharmacy Plus is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care. The Company is headquartered in London, UK, with a U.S. office in New Jersey. We believe mental health patients deserve the possibility of a better future. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. We are leading the world's largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing. - Compass Pathways Job overview: The Site of Care Account Lead (SOC-AL) is responsible for developing, managing, and supporting strategic relationships with priority Organized Care Groups (OCG) - Interventional Psychiatry Clinics, Health Systems, and Integrated Delivery Networks (IDN) that will serve as early adopters of COMP360 psilocybin therapy. This role focuses on account level strategy, operational readiness, and cross‑functional coordination to ensure sites of care have the infrastructure, training, and support needed to deliver high-quality psilocybin treatment. The SOC-AL partners closely with Sales, Marketing, Patient Engagement, Medical Affairs, Market Access, and Clinical Operations to build a scalable, sustainable ecosystem for COMP360 therapy. Location: Field-based in the Northeast region (New York, New Jersey, Washington DC, Massachusetts) and able to travel ~70% within region via plane, train, or car. Reports to: Director, Site of Care Marketing. Roles and responsibilities (Include but are not limited to): Account Strategy & Development • Identify, prioritize, and manage relationships with high potential OCGs inclusive of Interventional Psychiatry Clinics, IDNs, health systems, and behavioral health networks, • Develop, execute, and maintain account-level business plans aimed at long term growth and joint value creation based on each OCGs operational, clinical, and strategic needs, • Guide accounts through the stages of COMP360 readiness - from initial interest to full operational capability, • Assess site capabilities, infrastructure, staffing, and training needs to support safe and effective therapy delivery Operational Readiness & Implementation Support • Support sites in understanding and preparing for COMP360 psilocybin therapy workflows and help accounts navigate logistical requirements, • Identify operational barriers and collaborate internally to develop solutions, resources, or process improvements, • Track progress toward readiness milestones and ensure timely execution of implementation plans, • Deliver or coordinate educational sessions on COMP360 therapy, site of care models, and operational best practices, • Ensure accounts have access to Compass approved materials and implementation resources, • Support Compass's presence at conferences, workshops, and site of care events by engaging with Qualified Audiences Relationship Management & Engagement • Serve as the primary point of contact for prioritized OCGs, ensuring consistent communication and high-quality support, • Build strong relationships with Qualified Audience including – population -based clinical decision makers, administrators, operational directors, and financial decisionmakers (those developing/operationalizing care pathways), • Facilitate introductions and engagements with internal Compass Matrix teams (Patient Engagement, Medical Affairs, Sales, Market access) for functional expertise Insights & Business Planning • Develop and maintain account level business plans for target OCGs, • Provide regular and routine business plan updates to leadership and Matrix colleagues, • Gather account level insights on operational challenges, adoption drivers, reimbursement considerations, and competitive dynamics., • Provide structured feedback to Site of Care Marketing and Matrix team to inform ecosystem planning, • Monitor policy, regulatory, and payer developments that may impact account strategy Cross‑Functional Collaboration • Coordinate with Medical Affairs for appropriate scientific clinical exchange and education, • Collaborate with Patient Engagement to support REMS certification and reimbursement readiness, • Coordinate with Market Access to support payer-related discussions, • Coordinate with Marketing to refine messaging, tools, and resources based on account feedback, • Coordinate with Sales colleagues to engage with prescribing HCPs upon OCGs headquarter approval of individual site operational preparedness Candidate Profile: Required • Bachelor's degree in business, healthcare administration, life sciences, or related field, • 8+ years of experience in pharmaceutical or biotech managing strategic healthcare accounts, provider networks, health systems, specialty practices, integrated delivery networks (IDNs), or specialty pharmacy stakeholders in provider-facing healthcare services, • Strong understanding of behavioral‑health delivery, practice development, specialty‑care operations, or novel‑therapy implementation, • Demonstrated ability to manage complex accounts with multiple stakeholders, • Excellent communication, negotiation, and relationship building skills, • Ability to navigate complex healthcare organizations and coordinate stakeholders across clinical, pharmacy, finance, compliance, and operations functions Preferred • Experience in mental healthcare, neuroscience, or psychedelic assisted therapy, • Background in launching or scaling innovative care models or REMS monitored specialty therapeutics, • Familiarity with reimbursement pathways, payer dynamics, and health‑system economics, • Experience supporting launch or expansion of specialty pharmaceutical products requiring complex site-of-care readiness and patient access pathways Success Measures • Development and execution of annual strategic account plans for priority accounts, • Percentage of targeted accounts successfully completed launch readiness assessments within projected timelines, • Average time of progression from account identification through readiness milestones, • Strength and depth of relationships with key decisionmakers at strategic sites based on account engagement scores or stakeholder satisfaction ratings, • Quality and actionability of account insights delivered to internal teams, • Contribution to the scalability and consistency of the site of care model, • Alignment of account activities with broader commercial and medical strategy Compensation Description (annually): Our compensation package for permanent hires includes base salary, discretionary bonus, and equity, alongside our comprehensive benefits offering. 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 salary per annum】: $180,000—$215,000 USD Benefits: For an overview of our benefits package and compensation information, please visit "Joins us - Our Benefits". These include flexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health. 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 Description About the Company LTS is a global leader in transdermal and oral thin‑film drug delivery technologies. Our teams have pioneered breakthroughs such as the first contraceptive patch, nicotine patch, oral active ingredient film, and Parkinson’s patch. When you join LTS, you become part of a team that continues to shape the future of patient care and bring life‑changing therapies to market. At LTS, our purpose drives everything we do: We CARE. We CREATE. We DELIVER. We’re committed to fostering an employee experience that reflects our innovation — supportive, collaborative, and empowering. Across our New Jersey and Minnesota locations, you’ll work alongside knowledgeable experts on diverse projects in an environment where every day is different and your contributions truly matter. Position Overview LTS is seeking a motivated Calibration Technician at Level I, II, or III to join our Manufacturing Maintenance team in our West Caldwell, NJ site. We are hiring based on experience, education, and demonstrated proficiency, offering clear opportunities for professional growth as you develop your skills. • Location: West Caldwell, NJ, • Schedule: 7:30 AM – 4:00 PM, 1st Shift In this role, you will perform calibrations and support critical electronic instrumentation across our facility, directly contributing to the delivery of life-changing pharmaceutical products. What You'll Do/Key Responsibilities • cGMP Compliance: Abide by all cGMP, FDA, and DEA regulatory standards in all calibration and maintenance activities., • Calibration & Repair: Calibrate, document, troubleshoot, and repair/replace instrumentation for systems measuring level, temperature, pressure, flow, humidity, speed, time, and other process variables., • CMMS Management: Utilize Computerized Maintenance Management Systems (CMMS) with high proficiency for work logging and tracking., • Departmental Support: Provide technical support for electronic equipment across all facility departments., • Equipment Maintenance: Troubleshoot, repair, modify, and maintain pharmaceutical production equipment., • Planning & Ordering: Plan and estimate maintenance/calibration work and order necessary replacement parts., • Scheduling & On-Call: Maintain flexibility to work off-shift, weekends, and holidays based on production schedule demands, and participate in an on-call rotation schedule.Qualifications & Requirements, • Education: Associate’s degree required., • Experience Levels: Level I (0–1 yrs), Level II (2–3 yrs), Level III (4-5 yrs) in engineering or related technical experience., • Communication Skills: Above-average reading, writing, and verbal communication skills., • Technical & Math Skills: Above-average mathematical skills and hands-on proficiency with basic tools and calibration equipment., • Software Proficiency: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). CMMS experience preferred., • Learning & Practice: Ability and desire to learn disciplines and methods related to good calibration practices (GCP)., • Physical & Work Environment: Ability to stand for the majority of the day, lift/move 50+ pounds, and ability to gown for manufacturing cleanroom areas.Compensation & Experience Levels The role may be filled at Level I, II, or III based on each candidate’s education, relevant experience, technical proficiency, and ability to work independently. The hourly pay ranges and typical qualifications for each level are outlined below. Level I — Developing Technician Hourly pay: $33.00–$34.50 Typical experience: 0–1 years of engineering or related technical experience. Level I candidates bring a foundational understanding of calibration roles and controls, work closely with Senior Instrument Technicians, and focus on developing core calibration and control-system skills. Level II — Proficient Technician Hourly pay: $35.00–$36.50 Typical experience: At least 2–3 years of engineering or related technical experience. Level II candidates are fully proficient in a specific calibration discipline, work under moderate supervision, execute tasks independently, and troubleshoot systems within their area of expertise. Level III — Advanced Technician Hourly pay: $37.00–$38.50 Typical experience: At least 4–5 years of engineering or related technical experience. Level III candidates demonstrate broad proficiency across calibration disciplines, apply calibration principles in multiple functional areas, and work with minimal supervision. Relevant certification, such as ISA CSST, may also be considered as part of a candidate’s qualifications. Ready to Apply? Join LTS and become part of a team that shapes the future of patient care! If your experience aligns with Level I, II, or III, we encourage you to submit your application today. Equal Employment Opportunity LTS is an equal opportunity employer. We consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law.

Job Description This is a remote position. Director, Business Development Summary Our client is seeking a dynamic and results-oriented professional to spearhead their growth initiatives within the United States market. As the Director of Business Development, you will play a pivotal role in expanding our client’s footprint as a premier Contract Research Organization (CRO). Your primary mission involves cultivating strategic partnerships with key decision-makers in the pharmaceutical, biotech, and medical device sectors while driving significant revenue growth for their comprehensive pharmacovigilance offerings. This position is essential for ensuring their clients across the US, UK, and Europe maintain strict adherence to regulatory and quality standards through our end-to-end safety data management, signal detection, and risk management solutions. Responsibilities • Pinpoint and pursue fresh business prospects specifically within the US pharmaceutical, biotech, and medical device landscapes., • Formulate and implement a strategic sales roadmap designed to expand our client portfolio for pharmacovigilance solutions., • Establish and strengthen connections with critical stakeholders, such as Directors of Pharmacovigilance, Drug Safety, Regulatory Affairs, and Procurement., • Lead meetings, deliver presentations, and conduct demonstrations to highlight our service capabilities and unique value proposition., • Partner with internal departments, including operations, compliance, and subject matter experts, to craft proposals, respond to RFPs, and design tailored client solutions., • Serve as the company representative at industry conferences, trade shows, and professional networking events., • Manage a robust pipeline of potential leads and opportunities using CRM platforms while providing consistent progress reports to leadership., • Meet and exceed both quarterly and annual sales objectives., • Create and roll out a focused business development strategy tailored to the US pharmacovigilance market., • Utilize industry insights and professional networks to uncover high-potential opportunities within pharmaceutical, biotech, and medical device firms., • Forge executive-level relationships with senior leaders in Drug Safety, Regulatory Affairs, Clinical Development, and Procurement., • Articulate and promote our complete range of pharmacovigilance services alongside our proprietary technology platforms, including AI and automation tools., • Monitor industry trends, competitive dynamics, and regulatory changes to spot emerging service opportunities. Requirements Requirements: • Possess a Bachelor's or Master's degree in Life Sciences, Business Administration, or a closely related discipline., • Bring over a decade of experience in business development or client acquisition within the CRO, pharmacovigilance, or life sciences outsourcing sectors., • Demonstrate a robust professional network and a deep understanding of the US pharmacovigilance ecosystem., • Show a history of successfully securing new business and finalizing agreements with mid-to-large-sized pharmaceutical or biotech organizations., • Exhibit superior communication, negotiation, and presentation abilities., • Possess the capability to work autonomously, manage time efficiently, and excel in remote-first or hybrid work settings. Preferred Qualifications • Background in collaborating with international clients, particularly those based in the UK and EU., • Knowledge of industry regulations including FDA, EMA, MHRA, and ICH guidelines., • Prior experience in marketing outsourced drug safety or regulatory services.

Job DescriptionJob Summary: Instrument and Controls Engineer:The Instrument and Controls Technician is involved with the successful daily operation of the oil refining facility, and the modification and alteration of the plants automated control and power systems to accommodate business needs and ensure high plant availability. This requires close collaboration with other employees and management staff to ensure safe work and to set or re-set job priorities. Documentation, as required to document changes in plant physical or logic changes, and documentation to meet our goals of safety first, quality work and compliance with our customers’ requirements and concerns. Qualifications: Instrument and Controls Engineer: • High School Diploma or GED with at least 10 years I&E (I&C) experience in a chemical, food, pharmaceutical manufacturing environment. Familiarity with PLC based controls systems such as GE or Allen Bradley in a manufacturing environment., • Ability to analyze and interpret technical problems related to instrumentation or PLC logic., • Ability to read and understand company policies and procedures, technical datasheets or literature, P&IDs, electrical drawings (One-line drawings, loop drawings, control circuits, etc), • Ability to effectively present information either verbally or via written document (e-mail, MS Word/Excel, CMMS, etc) and respond to questions from groups of managers, co-workers, customers, and the general work force., • Ability to work with and apply mathematical concepts to practical situations., • Preferred: New Jersey Licensed Electrician (or working towards license), • Preferred: ISA Certification (Certified Control System Technician, Certified Industrial Electrician, Certified Instrument Technician)Duties & Responsibilities: Instrument and Controls Engineer:, • Monitor, repair, maintain and troubleshoot all field instrumentation, electrical equipment and controls systems including plant safety systems and plant power systems., • Install, loop check, maintain and troubleshooting process control systems comprised of transmitters, controllers, and valves operating in a PLC system., • Calibrate, monitor, repair, maintain, label and document all field instruments such as transmitters, controllers, valves, PLCs, plant safety systems, plant power systems, utility systems (HVAC), pH and conductivity meters, • Install, maintain, and troubleshoot electrical distribution and protection circuits up to 480VAC., • Fabricate and install rigid and flexible conduit, and run power and control wiring based on electrical code requirements, • Properly select, install and wire 120V-480V motors, single phase to three phase based on needs, • Strong working knowledge of National Electrical Code (NFPA 70), • Evaluate current instrumentation technology for process equipment and make recommendations for improvements., • Ensure all work orders are completed, documented and closed out in the site CMMS system, as per procedure., • Provide on-call support during assigned weeks to ensure 24/7 coverage, • Provide practical solutions to operations/ controls problems., • Scope, estimate and execute small capital / maintenance projects along with maintenance manager/ project director/ operations, etc., • Train other employees considering their needs and company needs., • Oversee the work by contractors as required on site to ensure safe and quality performance., • Look for opportunities to help work get done safer, faster and more cost effectively. Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws

Job DescriptionDirector, Pricing The Director of Pricing will lead the Pricing function, driving strategic pricing decisions that support profitable growth, competitive positioning, and successful product commercialization. Reporting to the Senior Vice President, Sales & Marketing, this role oversees pricing strategy, financial modeling, bid governance, and analytics across the portfolio. The Director of Pricing partners closely with Sales, Finance, Commercial Operations, and Leadership to evaluate new business opportunities, respond to market dynamics, and optimize gross-to-net performance. This role is both strategic and hands-on; owning the vision for pricing while ensuring precise execution across systems, processes, and people. Responsibilities: • Lead and develop the Pricing team, setting clear priorities, performance expectations, and strategic direction, • Suggest pricing strategy across customers, products, and channels to maximize profitability, market share, and long-term value, • Oversee the development of financial models, pricing scenarios, and launch strategies for new and existing products, • Ensure timely, accurate, and competitive responses to customer RFPs, ROFRs, bids, and other commercial proposals, • Partner with Sales to capture pricing intelligence, assess competitive dynamics, and support new business opportunities, • Proactively recommend price actions based on market trends, customer behavior, and portfolio performance, • Conduct customer- and product-level pricing analyses to mitigate pricing exposure while maintaining targeted share, • Ensure pricing accuracy across systems, minimizing pricing discrepancies, chargeback exposure, and operational errors, • Develop and maintain a comprehensive database of historical bids, including outcomes, learnings, and win/loss insights, • Drive the advancement of pricing analytics and reporting tools to improve decision-making, visibility, and performance tracking, • Serve as a key stakeholder in gross-to-net management, ensuring alignment between pricing strategy and financial outcomesQualifications:, • Bachelors Degree required, MBA or advanced business degree preferred, • 7 plus years of experience of generic pharmaceutical managerial experience within the pricing organization of a mid to large level company, • Deep understanding of the U.S. generic pharmaceutical market and the strategic role of pricing, • Strong expertise in gross-to-net concepts, including chargebacks, rebates, and pricing compliance, • Advanced analytical skills with strong proficiency in Excel and pricing/ERP systems (SAP, Model N, Power BI), • Experience working with Salesforce would be an added advantage, • Excellent verbal and written communication skills, with the ability to influence cross-functional stakeholders, • Highly detail-oriented, organized, and analytical, with a balance of strategic thinking and execution, • Self-starter with the ability to work independently while fostering strong collaboration across teams Base salary range: $185,000 - $205,000 per year. This is the anticipated salary range for fully qualified candidates. The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry, education, etc. \nCompany Description Openwork is a candidate-focused staffing company on a mission to bring ease, accessibility, and thoughtfulness to an industry we’ve held a footing in for 50+ years. We believe there’s more to life than livelihood, but that finding your dream job, career, or team is a really good place to start. Openwork is a candidate-focused staffing company on a mission to bring ease, accessibility, and thoughtfulness to an industry we’ve held a footing in for 50+ years. We believe there’s more to life than livelihood, but that finding your dream job, career, or team is a really good place to start.

Job Description [Job Summary] Reporting to the Finance Director responsible for managing the day-to-day activities of the Finance and Accounting function including managing general accounting, P&L and balance sheet activities, financial analysis, financial reporting, interact with internal and external partners and stakeholders to support the Finance and Accounting activities. [Job Description] • Manage day-to-day activities related to general accounting, P&L and balance sheet, AP and AR, • Gross-To-Net deductions, including chargebacks, admin fees and rebates calculations etc., • Prepare various sales reports for submission to external parties., • Prepare journal entries and adjustments for period-end closing, including inventory accounting, lease accounting., • Prepare financial statements and reports in compliance with US GAAP and IFRS., • Analyze accounts partner with Sales team and others., • Identify opportunities for process improvements, plan and execute improvement projects., • Support internal controls, compliance and external audits., • Assist in any system changes, internal control programs., • Assist in ad hoc initiatives. Requirements 5 or more years of experience in finance and accounting Understanding of US Generally Accepted Accounting Principles (GAAP) and IFRS Work experience in pharmaceutical industry preferred Experience in Gross to Net preferred Experience in SOX, audits, financial/accounting systems including SAP 1. SKILLS AND SPECIFICATIONS High Attention to details, accuracy essential and diligent personality Understanding in Accounting and Finance Proficiency in Microsoft Office Relevant Certification Bilingual in Korean and English 1. EDUCATION Bachelor’s Degree in accounting, finance or equivalence. Benefits • Salary 120-150k + Annual Bonus, • Full Benefits - Medical, Dental, Vision with different package, • 401k 4.5 % match, • 15 days PTO & 6 Sick Days

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care. The Company is headquartered in London, UK, with a U.S. office in New Jersey. We believe mental health patients deserve the possibility of a better future. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. We are leading the world's largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing. - Compass Pathways Job overview: The Senior Manager, Sales Operations will play an important role in enabling the success of our sales and commercial organization by leading operational excellence across sales planning, execution, and fleet management. This position will manage key processes including sales force targeting and alignment, CRM operations, incentive compensation administration, and fleet management while preparing and enabling Compass Pathways' field-facing teams for the successful launch and commercialization of COMP360 and future therapies. This role requires an analytical thinker and the ability to collaborate across functions to ensure our field teams are equipped for success. Location: Hybrid in our New York City office or remote on the East Coast in the United States. Reports to: Director, Sales Operations. Roles and responsibilities (Include but are not limited to): • Administer Incentive Compensation plans for the field sales teams and account directors, • Deliver ad hoc analysis to support sales activity, performance tracking, and strategic decision making, • Propose design ideas and maintain field sales dashboards, • Manage, maintain, and distribute sales and activity reports for field sales and leadership teams, • Partners with field sales on optimal CRM usage and field inquiries, • Manage and maintain field fleet decisions and usage, • Manage sales force alignments and work with sales leadership to optimize sales force deployment, • Maintain sales force sizing, HCP targeting, and call planning models to optimize coverage, • Ensure all processes adhere to regulatory and ethical standards, • Maintain documentation and audit readiness for all operational programs, • Additional needs as required by commercial operations leadership Candidate Profile: • Bachelor's degree in Business, Finances, Analytics, Administration, Operations Management or related field; advanced degree preferred, • 5-7+ years of experience in commercial operations, sales operations, field force effectiveness, sales enablement, or commercial analytics within the pharmaceutical or biotechnology industry, • Strong analytical and quantitative skills with proficiency in Excel, PowerPoint, and data visualization tools, • Expert in Incentive compensation plan administration and design, • Proven ability to successfully partner with field teams on operations and analytics needs, • Excellent communication and stakeholder management skills, • Deep understanding of the pharmaceutical/biotech commercial models and compliance requirements Compensation Description (annually): Our compensation package for permanent hires includes base salary, discretionary bonus, and equity, alongside our comprehensive benefits offering. 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 salary per annum】: $140,000—$190,000 USD Benefits: For an overview of our benefits package and compensation information, please visit "Joins us - Our Benefits". These include flexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health. 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 VITALIEF Vitalief is a consulting firm built exclusively for the research and clinical trial industry, providing innovative Consulting and Functional Service Provider (FSP) solutions to academic medical centers, health systems, sponsors, CROs, and site networks. By combining deep subject matter expertise with the experience of senior research practitioners, we help organizations accelerate study activation, optimize operations, improve financial performance, and build scalable workforce solutions that reduce costs, increase efficiency, and advance clinical breakthroughs for patients. POSITION SUMMARY Vitalief is seeking an experienced Lead Clinical Research Coordinator (CRC) to join our team as a full-time employee with a comprehensive benefits package. This role will support a portfolio of Phase II–IV oncology interventional clinical trials at a community hospital site in Newark, NJ. The ideal candidate will have a minimum of three years of clinical research coordination experience, a strong background supporting oncology trials across multiple disease areas, experience mentoring junior CRC team members, and the ability to excel in a collaborative, small-team environment. WHY VITALIEF? • Meaningful Impact: Support innovative oncology research that advances treatment options and improves patient outcomes., • People-First Culture: Join a collaborative environment focused on professional growth, innovation, and teamwork., • Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability coverage, a 401(k) retirement plan, and comprehensive healthcare benefits., • Work Location: Fully on site in Newark, NJ for the first 3 months. Following training, transition to a hybrid schedule of 4 days onsite and 1 remote day per week., • Schedule: Monday through Friday, 8:00 AM – 4:30 PM., • Salary Range: $75,000 to $90,000 depending on experience. RESPONSIBILITIES • Support the execution of Phase II–IV oncology clinical trials, including pharmaceutical-sponsored, ECOG, and investigator-initiated studies., • Manage trials across multiple oncology disease groups, including GYN, Breast, GI/GU, Head & Neck, and Lung cancers., • Oversee a portfolio of approximately 15–20 active clinical trials in a fast-paced, high-volume clinical environment., • Identify and screen potential study participants using physician schedules, pathology reports, multidisciplinary tumor boards, referrals, and other clinical resources., • Obtain informed consent and enroll eligible patients in accordance with protocol requirements and regulatory standards., • Manage patients throughout the clinical trial lifecycle, from consent through completion of active treatment., • Educate patients regarding study procedures, treatment schedules, and protocol requirements., • Coordinate patient care activities with physicians, infusion teams, nursing staff, radiology, pathology, laboratories, and other clinical departments., • Monitor patient safety, document clinical outcomes, and ensure timely reporting of adverse events and Serious Adverse Events (SAEs)., • Maintain accurate clinical trial documentation, source records, regulatory files, patient calendars, and study-related documentation., • Ensure compliance with study protocols, Good Clinical Practice (GCP), institutional policies, and regulatory requirements., • Provide guidance and mentorship to junior CRC team members and support team collaboration. QUALIFICATIONS • Bachelor’s degree in health science, life science, nursing, or a related field., • Minimum of 3 years of clinical research coordination experience supporting interventional Phase II–IV clinical trials., • Required oncology clinical trial experience, preferably with exposure to multiple oncology disease areas., • Experience with patient identification, pre-screening, informed consent, enrollment, retention, regulatory compliance, and clinical data management., • Prior experience mentoring or supporting the development of junior CRCs., • Proficiency with EPIC and OnCore™ CTMS., • Ability to manage multiple concurrent studies while maintaining strong attention to detail and organization., • Adaptable, solutions-oriented mindset with the ability to work effectively in a small, collaborative team environment., • Strong interpersonal and communication skills with the ability to work closely with physicians, nurses, research staff, hospital departments, and external partners., • Experience ensuring SAEs are documented, completed, and reported within protocol-defined timelines., • Proficiency with Microsoft Office applications and clinical research systems. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. 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 15wfm1ifBK

Job DescriptionCompany Description Eurofarma is a leading multinational pharmaceutical company headquartered in Brazil, with operations across Latin America, the United States, and Africa. The company operates in 24 countries, employs more than 13,000 employees globally, and generated approximately BRL 11 billion in net revenue in 2024 (approximately USD 2.2 billion). The U.S. market is a strategic growth area for Eurofarma as we continue to expand our presence and capabilities in the region. Currently we have 30 employees. Job Description This position serves as the Finance Manager for Eurofarma USA and is a key member of the local leadership team. The role partners closely with the CEO/General Manager and other functional leaders to support strategic decision-making, financial performance, compliance, and business growth.tegic priorities. The position requires strong collaboration across multiple functions, including Commercial, Human Resources, Regulatory Affairs, and Corporate Finance. As such, the ability to work effectively in a multidisciplinary environment and influence across functions is essential for success. The role also serves as an important link between the U.S. operation and regional/global finance teams, ensuring alignment with corporate governance standards, financial reporting requirements, and stra Key Responsibilities Strategic Finance & Business Partnership • Partner closely with the CEO and leadership team to support business strategy and decision-making, • Develop financial models, scenario analyses, and insights to guide key initiatives Financial Planning & Performance • Lead budgeting, forecasting, and long-term financial planning processes, • Drive performance monitoring and provide actionable insights Cash Flow & Financial Discipline • Oversee cash flow, liquidity, and working capital management, • Support capital allocation and financial discipline Accounting, Compliance & Controls • Ensure compliance with U.S. GAAP, tax regulations, and internal policies, • Lead audits, tax filings, and maintain strong internal controls Operations & Execution • Oversee day-to-day finance operations, ensuring efficiency and scalability, • Drive continuous improvement across financial processes Stakeholder Management • Manage relationships with auditors, banks, and external advisors Leadership • Build, lead, and develop a high-performing finance team Qualifications Education • Bachelor’s degree in Finance, Accounting, Economics, or related field, • MBA or advanced degree preferred, • CPA or equivalent certification is a strong plus Experience • 8–12+ years of progressive experience in finance or accounting, • Proven leadership experience, • Strong background in both strategic finance and operational execution, • Experience with U.S. GAAP, audits, and tax environment, • Experience working closely with senior leadership, • Experience in pharmaceutical, healthcare, or regulated industries preferred. Above all, account reconciliations/rebates for the US government's MEDICARE and MEDICAID programs. Additional Skills • Strong financial and analytical capabilities, • Excellent communication and stakeholder management skills, • Ability to thrive in a fast-paced environment, • Abilities to interact in a multidisciplinary manner in related areas of the company., • English Native plus Fluency in Spanish or Portuguese. Additional Information All your information will be kept confidential according to EEO guidelines.

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

Job DescriptionABOUT VITALIEF Vitalief is a consulting firm built exclusively for the research and clinical trial industry, providing innovative Consulting and Functional Service Provider (FSP) solutions to academic medical centers, health systems, sponsors, CROs, and site networks. By combining deep subject matter expertise with the experience of senior research practitioners, we help organizations accelerate study activation, optimize operations, improve financial performance, and build scalable workforce solutions that reduce costs, increase efficiency, and advance clinical breakthroughs for patients. POSITION SUMMARY Vitalief is seeking an experienced Senior Clinical Research Coordinator (CRC) to join our team as a full-time employee with a comprehensive benefits package. This role will support a portfolio of Phase II–IV oncology interventional clinical trials at a community hospital site in Newark, NJ. The ideal candidate will have a minimum of three years of clinical research coordination experience, a strong background supporting oncology trials across multiple disease areas, experience mentoring junior CRC team members, and the ability to excel in a collaborative, small-team environment. WHY VITALIEF? • Meaningful Impact: Support innovative oncology research that advances treatment options and improves patient outcomes., • People-First Culture: Join a collaborative environment focused on professional growth, innovation, and teamwork., • Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability coverage, a 401(k) retirement plan, and comprehensive healthcare benefits., • Work Location: Fully on site in Newark, NJ for the first 3 months. Following training, transition to a hybrid schedule of 4 days onsite and 1 remote day per week., • Schedule: Monday through Friday, 8:00 AM – 4:30 PM., • Salary Range: $75,000 to $85,000 depending on experience. RESPONSIBILITIES • Support the execution of Phase II–IV oncology clinical trials, including pharmaceutical-sponsored, ECOG, and investigator-initiated studies., • Manage trials across multiple oncology disease groups, including GYN, Breast, GI/GU, Head & Neck, and Lung cancers., • Oversee a portfolio of approximately 15–20 active clinical trials in a fast-paced, high-volume clinical environment., • Identify and screen potential study participants using physician schedules, pathology reports, multidisciplinary tumor boards, referrals, and other clinical resources., • Obtain informed consent and enroll eligible patients in accordance with protocol requirements and regulatory standards., • Manage patients throughout the clinical trial lifecycle, from consent through completion of active treatment., • Educate patients regarding study procedures, treatment schedules, and protocol requirements., • Coordinate patient care activities with physicians, infusion teams, nursing staff, radiology, pathology, laboratories, and other clinical departments., • Monitor patient safety, document clinical outcomes, and ensure timely reporting of adverse events and Serious Adverse Events (SAEs)., • Maintain accurate clinical trial documentation, source records, regulatory files, patient calendars, and study-related documentation., • Ensure compliance with study protocols, Good Clinical Practice (GCP), institutional policies, and regulatory requirements., • Provide guidance and mentorship to junior CRC team members and support team collaboration. QUALIFICATIONS • Bachelor’s degree in health science, life science, nursing, or a related field., • Minimum of 3 years of clinical research coordination experience supporting interventional Phase II–IV clinical trials., • Required oncology clinical trial experience, preferably with exposure to multiple oncology disease areas., • Experience with patient identification, pre-screening, informed consent, enrollment, retention, regulatory compliance, and clinical data management., • Prior experience mentoring or supporting the development of junior CRCs., • Proficiency with EPIC and OnCore™ CTMS., • Ability to manage multiple concurrent studies while maintaining strong attention to detail and organization., • Adaptable, solutions-oriented mindset with the ability to work effectively in a small, collaborative team environment., • Strong interpersonal and communication skills with the ability to work closely with physicians, nurses, research staff, hospital departments, and external partners., • Experience ensuring SAEs are documented, completed, and reported within protocol-defined timelines., • Proficiency with Microsoft Office applications and clinical research systems. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. 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 1z6ZeKKdwR