Trabajos pharmaceutical compliance en Paterson, New JerseyCrear alertas

Territory: White Plains, NY - Neurology Target area for territory is White Plains - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Westchester, White Plains, and the Bronx. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. It’s a very exciting time to join our team as we lead the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager, you lead the promotion of our infusion product, driving demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the local market and partnering to deploy approved services necessary to meet the needs of each account/customer. Our Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply customer and data-based insights to build opportunities, develop strategy & tactics and prioritize resources to enhance territory effectiveness in competitive markets. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Engage with multi-disciplinary customers using a total office call approach to communicate value proposition of a new delivery method. Customer Development - Entrepreneurial mindset to gain access, build and maintain productive internal and external relationships through effective communication and collaboration based on customer needs and organizational goals. Payer Access - Ability to grasp sophisticated reimbursement and distribution processes in a complex coverage landscape. Anticipates and communicates impact on product portfolio to key internal and external partners and effectively addresses payer access issues (Medicare, Medicaid, Commercial) using Lundbeck resources. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Demonstrates a clear and detailed understanding of the disease state and its impact on customers and patients including the full range of treatment options available. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices. Accountability and adherence to corporate, FDA, and PDMA guidelines. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university., • 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience., • Ownership and accountability for the development and execution of a fully integrated account plans., • Self-starter, with a strong work ethic and outstanding communication skills., • Proven track record of consistent sales performance., • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually., • Must be computer literate with proficiency in Microsoft Office Software., • Must live within 40 miles of territory boundaries., • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Previous experience within a specialty product sales force., • Infusion/rare disease sales experience in both the Outpatient Infusion setting and Specialty Pharmacy channel with a strong understanding of pricing and reimbursement., • Neurology experience specific to migraine., • Experience in both the medical or specialty pharmacy benefit market., • Experience working with high influence customers in physician clinics, integrated health systems, infusion centers and alternative sites of care., • Product launch or expansion experience, particularly in a new therapeutic class., • Strong analytical background, and experience using sales data reporting tools to identify trends., • Strong leadership through participation in committees, job rotations, panels and related activities. TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $155,000 - $172,000 and eligibility for a sales incentive target of $41,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our _. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

Job Description Job Title: Cell & Gene Therapy Associate Job Description • The Cell & Gene Therapy Associate supports clinical manufacturing operations in a cellular therapy facility, working in clean room environments to process cells and samples using aseptic techniques and GMP practices., • This role focuses on clean room qualification, cell and tissue culture activities, and preparation of safe and efficacious cell products for clinical use., • It is an excellent opportunity for individuals early in their scientific career who are eager to gain hands-on experience, receive extensive training, and grow within a fast-paced, team-oriented environment. Responsibilities • Assist with clean room qualification activities, including performing burden cleaning to prepare rooms for testing., • Run supplies and materials to support clean room operation and processing, ensuring that all required items are available when needed., • Perform aseptic gowning procedures to enter the clean room and participate in qualification and manufacturing activities., • Work within manufacturing operations to help process cells and samples in accordance with established procedures and quality standards., • Process cultures, cryopreserve, and manipulate cell products using aseptic technique to maintain product integrity and sterility., • Follow Good Manufacturing Practice (GMP) standards and adhere to standard operating procedures (SOPs) in all aspects of laboratory and clean room work., • Support cellular facility operations, including preparation of media and reagents for cell therapy processes., • Perform any and all processing and testing required to produce and assess safe and efficacious cell therapy products., • Work in a clean room environment to carry out stem cell preparation and cell/tissue culture activities., • Handle batch records and support cell processing steps such as cell expansions, volume reductions, depletions, and enrichments., • Contribute to clinical trial support by executing laboratory and manufacturing tasks that align with clinical protocols and regulatory requirements., • Communicate effectively within a large team of operators and with operations leadership to coordinate daily activities and priorities., • Maintain compliance with facility procedures for clean room entry, gowning, and environmental controls., • Support a fast-paced production environment by adjusting to changing priorities and schedules as needed. Essential Skills • Experience working within a cell-based biology laboratory, either in an academic or industry setting., • Hands-on experience with aseptic technique in laboratory or clean room environments., • Familiarity with GMP practices and the ability to follow SOPs consistently., • Experience with cell culture, including handling and maintaining cell and tissue cultures., • Ability to work effectively in a fast-paced environment and adapt to changing operational needs., • Strong communication skills and the ability to collaborate within a team environment., • Capability to perform clean room gowning procedures and work comfortably in a controlled environment., • Experience working with batch records and documented procedures., • Ability to support processes such as cell expansions, volume reductions, depletions, and enrichments., • Understanding of basic biology laboratory operations, including media preparation and general lab practices. Additional Skills & Qualifications • Associate or bachelor’s degree in biology or a related scientific field is preferred., • Bachelor’s degree in a scientific discipline is strongly preferred for candidates seeking long-term growth in cell and gene therapy., • Previous experience in a pharmaceutical, biotechnology, or clinical manufacturing environment is a plus., • Experience in stem cell preparation and cell/tissue culture is highly beneficial., • Exposure to clinical trial support activities within a laboratory or manufacturing setting is an advantage., • Previous experience with lab gowning procedures and working in clean room or controlled environments., • Demonstrated positive attitude, strong work ethic, and willingness to learn new techniques and processes., • Ability to manage time effectively and maintain attention to detail in documentation and processing. Work Environment • This role is based in clinical manufacturing laboratories and cellular therapy clean rooms, where work is performed under strict GMP and aseptic conditions., • The associate joins a large team of operators and reports into operations leadership, receiving extensive training on aseptic gowning, clean room procedures, and manufacturing processes., • Training for the first 2–3 months typically follows a Monday–Friday schedule from 8:00 a.m. to 4:00 p.m., • After training, the position requires flexibility on shifts and openness to working weekends, including Saturday and Sunday., • Schedules may include first and second shifts, with some shifts extending as late as approximately 2:30 a.m., and arrival times may occasionally be communicated the day before. Job Type & Location This is a Contract to Hire position based out of Allendale, NJ. Pay and Benefits The pay range for this position is $29.78 - $29.78/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Aug 13, 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing 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 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.

Job Description Now Hiring: Pharmaceutical Packers & Production Associates - West Caldwell ¡Sí, hablamos Español! Interested in applying? Simply scroll to the bottom of the page for application instructions. PROSTAR Staffing is partnering with a well-established pharmaceutical packaging facility and is currently hiring for the following positions: • Pharmaceutical Packers, • Material Handlers, • Porters, • Machine Operators, • Operator Assistants Pay Rate • $15.92 - $22.00 per hour DOE Available Shifts 1st Shift - ProductionMonday - Friday • 6:00 AM - 2:30 PM 2nd Shift - ProductionMonday - Friday • 3:15 PM - 11:45 PM Saturday • 2:15 PM - 10:45 PM Work Locations • West Caldwell, NJ, • Paterson, NJ Job Responsibilities • Assemble and label medication packages, ensuring accurate counts and proper documentation., • Inspect finished products for accuracy, appearance, labeling, and functionality., • Follow Good Manufacturing Practices (GMP) and all regulatory requirements to maintain compliance and product quality., • Collaborate with Quality Assurance, Production, and Maintenance teams to support efficient operations., • Maintain a clean, organized work area and follow all workplace safety procedures., • Perform duties in a fast-paced manufacturing environment while meeting productivity and quality standards. Requirements • Background check required., • Drug screening required., • Ability to work in a fast-paced, GMP-regulated environment., • Strong attention to detail and commitment to quality., • Ability to stand, move, and perform repetitive tasks throughout the shift., • Noise levels may range from moderate to high. Ready to Get Started? Call Us Today: 973-750-9000 Walk-Ins Welcome! Office Location PROSTAR Staffing 159 Speedwell Avenue Morristown, NJ 07960 Office Hours Monday - Friday 8:30 AM - 3:00 PM Hours may vary. Please call ahead to confirm availability. Apply today and start your career with a growing pharmaceutical manufacturing team! #ZIP

Job Description Pharmaceutical Manufacturing Company Urgently Hiring a Slitting Machine Operator on First Shift Please apply now, and if interested, can be set up with an interview and start within a week! Location: West Caldwell, NJ Shift: 6am-2:30pm (Monday-Friday) Pay: $25-$27/hour ; Overtime: $37.50-$40.50/hour Type of Position: Direct Hire (Paid Time Off, Holiday Pay, Vacation Pay, Medical, Dental, Vision, 401k, etc.) Job Description The Slitting Operator supports pharmaceutical manufacturing operations within a highly regulated clean room environment. This role sets up, operates, and monitors slitting equipment to convert specialty raw materials into finished rolls while strictly adhering to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and quality standards. The Slitting Operator works closely with Production and Quality Assurance teams to ensure products meet specifications, documentation is accurate, and safety and cleanliness requirements are consistently maintained. Responsibilities • Set up, operate, and monitor slitting machinery to convert raw materials into finished rolls according to work orders and product specifications., • Perform machine setup activities, including material changeovers, adjustments, and alignment to ensure efficient and accurate production., • Clean and maintain slitting equipment as required to support reliable operation and compliance with clean room and pharmaceutical standards., • Inspect materials and finished rolls throughout the production process to verify compliance with quality standards and customer specifications., • Accurately complete production records, batch documentation, labels, and inventory transactions to maintain traceability and regulatory compliance., • Perform basic troubleshooting on slitting equipment and promptly report equipment malfunctions or issues to maintenance or supervision., • Follow Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and all safety requirements at all times., • Maintain a clean, organized, and compliant work area in accordance with pharmaceutical clean room standards., • Handle, move, and transport materials safely while maintaining product integrity, correct labelling, and full traceability., • Operate and monitor automated production, packaging, or processing equipment used in the manufacture of pharmaceutical products as needed., • Collaborate closely with Quality Assurance and Production teams to ensure product quality, adherence to production schedules, and efficient workflow., • Support general production activities such as packaging, filling, inspection, and packaging line operations when required.Job Type & Location This is a Permanent position based out of Caldwell, NJ. Pay and Benefits The pay range for this position is $52000.00 - $58240.00/yr. This is a direct hire position which includes internal benefits, PTO, and Holiday from day one. Workplace Type This is a fully onsite position in Caldwell,NJ. Application Deadline This position is anticipated to close on Aug 14, 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. Company Description We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow. We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.

Job DescriptionImage CaptionAbout 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 hiring a Slitting Operator II in West Caldwell, NJ. In this role, you will operate slitting and spooling equipment to process raw materials, medical tape components, and coated non-active/active drug laminates and films while following MBRs, SOPs, cGMP requirements, and safety standards. This is a great opportunity for a skilled production professional who takes pride in quality, accuracy, and teamwork. Location: West Caldwell, NJSchedule: 6:15 AM - 2:30 PM (1st Shift)- Monday-Friday; occasional overtime available Job Responsibilities • Operate slitting and rewinding equipment to process raw materials, medical tapes, and coated laminates and films., • Complete in-process checks and batch record documentation accurately according to manufacturing orders., • Set up equipment correctly, including wind direction and tension settings, in accordance with SOPs., • Use slitting tools and machine components safely and effectively, including scissors, crush, and razor knives., • Label, package, and prepare finished materials for transfer or shipment as required., • Clean equipment and maintain the work area in compliance with safety, environmental, and housekeeping standards., • Complete all aspects of the slitting operation, including in-process control activities and batch record documentation according to manufacturing orders., • Follow manufacturing procedures and support safe, efficient production operations as needed.Minimum Qualifications, • High school diploma or equivalent., • 4-5 years of production or manufacturing experience., • Ability to read, write, and communicate clearly in a manufacturing environment., • Basic math skills, metric conversions and ability to complete production documentation accurately., • Comfort using measuring tools, equipment, and manufacturing machinery., • Able to wear safety glasses, hearing protection, full face/half mask respirator, latex gloves, tyvek suit and other safety equipment as needed.Preferred Qualifications, • Experience in regulated manufacturing environments such as pharmaceutical, medical device, or related industries is a plus., • Core cutter experience helpful We Offer • Competitive compensation and benefits package, • Opportunities for professional growth and development, • A collaborative and supportive work environment, • The chance to contribute to improving patient lives LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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 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 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 Description A growing pharmaceutical company with a strong mission-driven culture is hiring a Director of Network and Infrastructure Operations to take ownership of network operations across the Americas region. This is a highly visible infrastructure leadership role supporting business-critical environments across research, manufacturing, labs, corporate offices, commercial operations, and cloud platforms. This is a strong fit for a network leader who enjoys both strategy and execution: setting direction, improving reliability, strengthening security, managing vendor performance, and making sure the network is ready for the business, not constantly chasing it from behind. The environment is modern, complex, and global, with meaningful work around SD-WAN, cloud connectivity, Zscaler, Zero Trust, segmentation, monitoring, business continuity, and network modernization. The right person will have the opportunity to influence standards, improve operations, and be the Americas voice in global infrastructure planning. This is a direct hire role based in Clifton, NJ with a hybrid schedule 3 days onsite each week. The Role You'll Play As the Director of Network and Infrastructure Operations, you will be responsible for end-to-end leadership of network infrastructure operations across all Americas sites. You will own the regional hybrid network ecosystem, including SD-WAN, LAN/WAN, wireless, cloud connectivity, remote access, Zscaler, firewalls, DNS/DHCP/IPAM, IDS/IPS, NAC, NDR, and secure internet egress infrastructure. You will report to the Americas Infrastructure Lead & Global Network Lead and work closely with U.S. regional leads, global infrastructure teams, IT Security, site leadership, network vendors, and managed service partners. Key responsibilities include: Lead Americas network operations across SD-WAN, LAN/WAN, Wi-Fi, remote access, Zscaler ZIA/ZPA, and AWS cloud network connectivity Ensure high availability, reliability, and performance of critical network services across research, manufacturing, labs, corporate offices, commercial operations, and cloud workloads Oversee network incident, problem, and request management, including escalation paths, service desk runbooks, KB documentation, and root cause analysis Implement proactive monitoring, telemetry, logging, alerting, and performance optimization using tools such as ThousandEyes, SolarWinds, Zscaler analytics, and CloudWatch Maintain standardized network configurations aligned with global architecture, Zero Trust, segmentation, firewall policies, and secure internet egress requirements Lead regional network budgeting, forecasting, operational spend management, licensing, carrier contracts, and cloud networking cost control Manage vendors and managed service partners, including carriers, SD-WAN providers, Zscaler, firewall partners, monitoring vendors, SLA performance, QBRs, renewals, and service onboarding Ensure connectivity resilience and disaster recovery readiness through redundant WAN paths, HA firewall clusters, diverse internet egress, SD-WAN failover, DNS/DHCP/IPAM recovery, and cloud routing restoration Serve as the primary liaison between site operations, global network engineering, cloud networking teams, IT Security, procurement, regional leadership, and business stakeholders Plan and execute regional network projects, including SD-WAN upgrades, Zscaler policy rollouts, firewall refreshes, wireless modernization, cloud connectivity expansion, and site readiness initiatives Partner with Security to maintain a strong network security posture, support vulnerability remediation, enforce least-privilege access, and ensure compliance with audit, GxP, regulatory, and enterprise security requirements Mentor regional infrastructure personnel, support workforce planning, build technical capability, and foster a culture of ownership, operational discipline, customer focus, and continuous improvement Background Profile The ideal candidate is a senior network infrastructure leader with deep hands-on technical experience, strong operational discipline, and the ability to lead teams, vendors, and global stakeholders in a complex enterprise environment. Bachelor's degree in IT, Computer Science, or a related discipline 10+ years of experience leading network engineering and operations teams in a complex, multi-site enterprise environment Deep expertise in SD-WAN, LAN/WAN, Wi-Fi, firewalls, DNS/DHCP/IPAM, cloud networking, and hybrid network design Practical experience with AWS and Azure cloud networking, including VPC/VNet design, routing, security controls, and hybrid connectivity models Experience with Zscaler ZIA/ZPA, Zero Trust access models, and secure internet egress architectures Strong understanding of network security, segmentation, identity-based access controls, and cybersecurity integration Proven ability to lead technical teams and manage vendor partnerships Strong troubleshooting, stakeholder communication, and operational leadership skills Familiarity with regulated environments and audit requirements Preferred experience includes: Experience in pharmaceutical, biotech, manufacturing, or another regulated sector Experience managing MSP-driven operating models Familiarity with Fortinet, Cisco, Aruba, AWS/Azure networking tools, Zscaler, and enterprise monitoring solutions ITIL certification or experience with ITIL-based processes Project management or leadership training certifications

Job DescriptionRole Overview: The Junior Mechanical / Industrial Engineer supports the operation, maintenance, troubleshooting, and continuous improvement of packaging equipment within a pharmaceutical manufacturing environment. This is a hands-on engineering role focused on equipment reliability, preventive maintenance, operational efficiency, and production support. Working under limited supervision, this position assists with equipment maintenance, changeovers, troubleshooting activities, and process optimization initiatives while ensuring compliance with cGMP, safety, and environmental standards. The ideal candidate has a strong mechanical aptitude, interest in manufacturing operations, and the ability to thrive in a fast-paced production environment. Job Requirements: • Associate's or Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related technical field preferred., • Candidates with a high school diploma/GED and equivalent hands-on mechanical experience will also be considered., • 1–3 years of experience supporting manufacturing equipment, packaging machinery, maintenance operations, or industrial systems preferred., • Strong mechanical aptitude and interest in equipment troubleshooting, maintenance, and manufacturing operations., • Knowledge of lockout/tagout (LOTO) procedures and workplace safety practices., • Experience reading and interpreting technical diagrams, gauges, equipment manuals, and production documentation., • Basic math and analytical skills., • Comfortable working in a fast-paced manufacturing environment.Preferred Qualifications:, • Technical school certification or engineering-related coursework., • Experience with mechanical and electrical systems in a packaging, pharmaceutical, or manufacturing environment., • Familiarity with machine shop equipment, hand tools, and maintenance practices., • Internship, co-op, or entry-level experience within a manufacturing, pharmaceutical, packaging, or industrial environment preferred.Personal Attributes / Skills:, • Strong problem-solving mindset and willingness to learn., • High attention to detail and commitment to quality., • Effective communication and teamwork skills., • Self-motivated with a hands-on approach to troubleshooting and equipment support., • Organized and capable of managing multiple priorities in a production environment. Key Responsibilities: • Support Equipment Reliability: Assist in maintaining packaging equipment to ensure consistent production performance and minimize downtime., • Perform Preventive Maintenance: Conduct routine inspections and preventive maintenance activities on packaging machinery and related equipment., • Support Equipment Changeovers: Assist with line changeovers, equipment setup, and operational adjustments to meet production requirements., • Troubleshoot Equipment Issues: Support the diagnosis and resolution of mechanical and operational issues affecting packaging equipment., • Identify Process Improvements: Participate in equipment optimization and continuous improvement initiatives to enhance efficiency and reliability., • Ensure cGMP Compliance: Perform all work in accordance with cGMP standards, safety requirements, and environmental regulations., • Maintain Equipment Performance: Monitor equipment operation and communicate downtime events or recurring issues to supervisors and technical teams., • Promote Safety Standards: Identify potential hazards and support corrective actions to maintain a safe work environment., • Support Production Operations: Collaborate with maintenance, engineering, quality, and production teams to support manufacturing goals., • Maintain Documentation: Complete maintenance records, equipment logs, and related documentation accurately and timely., • Perform other job-related duties as assigned. GRIT Staffing & HR Solutions is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees and applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. If you require a reasonable accommodation during the application or interview process, please contact us at eoc@gritstaffinghr.com so we can assist you.

Job DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements, • Travel may be requiredREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs.The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. • The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes., • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality AgreementsREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Travel may be required, • Strong business acumen, • Experience with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description 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: Accountable for the oversight, management, and execution clinical studies (feasibility, country and site selection, engagement in site start-up activities, patient recruitment and study initiation, conduct, and close-down, vendor oversight and timeline management, tracking clinical data, etc.) for global clinical studies with adherence to all relevant regulations including FDA, ICH GCP, and global regulatory requirements. This is a hybrid position that requires to travel to the Paramus, NJ office at least twice a week. Essential Duties and Responsibilities: • Plan, implement, manage, and report for regional or global clinical studies., • Oversee, manage, and lead selection process of CROs for regional or global clinical studies., • Direct 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., • Lead, oversee, and manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans., • Accountable for the creation of study related documentation (protocol, ICF, CRF, operations manuals etc.)., • Oversee the tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans., • Ensure compliance of investigational sites with SOPs, FDA regulations and ICH GCP guidelines to ensure 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 and output of deliverables in accordance with Statistical Analysis Plan., • Accountable for oversight of clinical team members responsible for managing clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies and investigational product to global clinical trial sites., • Implement project specific training program and training materials., • Create and maintain clinical SOPs and oversee the TMF for assigned projects as part of global QMS and TMF processes., • As needed and required perform other tasks and functions., • Ensure inspection readiness for audits and/or Health Authority inspections Supervisory Responsibilities: • Supervise two (2) or three (3) Senior Clinical Study Managers and one Associate Director; including expatriates from Japan Qualifications: • Extensive experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets, oversight of CROs/vendors and management of timeline, • Proven ability to lead and motivate the cross-functional team to achieve project goals and deliverables on time, with high quality, and within budget., • Demonstrated leadership and accomplishment in operational/project management roles., • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include extensive drug development collaboration with global project teams including project managers, Nippon Shinyaku (JapanHQ), external and internal stakeholders, partners, and vendors., • Builds strong, open, and collaborative working relationships characterized by mutual respect with superiors, peers and subordinates within and outside the company., • Thorough understanding of clinical operations as related to the planning, initiating, conducting, and closing clinical studies., • Ability to anticipate and timely escalate issues and to define appropriate action plans., • Decision-making and problem-solving skills, • Proven ability to handle multiple tasks and projects, including excellent time management and prioritization skills., • Strong organization, communication, and presentation skills, • Team player, flexible, ability to adapt to change., • Experience actively managing resources, staff, integrated timelines, and budgets for one or multiple assets in development Education and Experience: • Bachelor’s Degree in sciences or related field with 10 + years of pharmaceuticals/biotech experience. Certified Project Management Professional (PMP) preferred., • Minimum of 10 + years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials., • Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, Advisory Board Meeting, etc.), • Program and project management experience preferred., • PMP certification preferred., • Oncology and rare disease clinical trial experience preferred. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $210,000to $245,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training, • Flexible Work Arrangement Programs Applications will be accepted until September 9, 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 DescriptionQuality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. • Develop and maintain training program within Quality Control which includes, onboarding and continuous training, • Manage deviations, CAPAs, change controls and document review to ensure compliance, • Ensure OOS investigations are completed adequately., • Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories, • Identify resources needed for training and compliance and build team accordingly, • Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements., • Monitor effectiveness of CAPAs, change control activities, and audit observation closure., • Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators, • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory experience in a cGMP environment a must, • 3-5 years’ experience in the pharmaceutical, biologics ore related industry, • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position, • Sound understanding of cGMPs, • Experience in laboratory training and compliance, • External laboratory management experience, • Strong knowledge of testing methodologies, philosophies, method validation and method transfers., • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Experience with laboratory training programs, • Knowledge of GMP requirements, • Excellent organizational and leadership skills, • Outstanding analytical problem-solving abilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description One of the nation’s largest independent testing facilities seeks a laboratory Supervisor with a minimum of 4 years experience testing products and raw materials for the pharmaceutical, nutritional, cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Must have the technical ability to understand client requirements, technical documentation, and be able to prepare testing protocols. Job Type: Full-time. Base Hours: 8:30AM – 5:30PM Monday through Friday MINIMUM QUALIFICATION REQUIREMENTS To perform this job, an individual must be able to perform each essential duty satisfactorily and meet the educational and experience requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES • Supervise the daily operation of the Analytical laboratory including but not limited to the planning and scheduling of personnel and project related activities., • Responsible for technical problem solving; and the ordering of lab supplies in a timely manner. Liaise with the Chief Chemist on chemistry/technical and equipment issues., • Liaise with the Laboratory Manager in maintaining client contact and project planning, providing project status updates; notification of unexpected project-related events and non-conformances., • Maintain the laboratory in a clean and orderly manner; ensure the proper functioning of lab equipment through the timely execution of maintenance, calibration, qualification and performance verification activities in accordance with company SOPs., • Responsible for the training of chemists or technicians. Ensure that employees are properly trained for performing assigned tasks, and cross-trained for added department flexibility., • Responsible for conducting or assigning peer review of departmental testing., • Conduct laboratory testing in a safe, efficient manner and in accordance with appropriate procedures, SOPs, and all applicable regulations., • Document all testing activities in company-issued laboratory notebooks or logbooks, and in accordance with SOPs and GMP/GLP regulations., • Ensure that all the testing activities are conducted in compliance with GMP, GLP, DEA, EPA, ISO 17025, OSHA regulations, SOPs and Test Methods, official Compendia and approved protocols. OTHER KNOWLEDGE, SKILLS and ABILITIES • Perform technical writing and peer review as needed, • Capable of working in a fast paced environment., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Authorization to work in the United States indefinitely without restriction or sponsorship. EDUCATION AND EXPERIENCE • Bachelors Degree (BA/BS) Chemistry or related science discipline - Required, • Master Degree (MS/MA) Chemistry or related science discipline - Preferred, • Minimum 4 years of chemicals/pharmaceuticals testing experience in a GMP laboratory utilizing techniques such as: HPLC, GC, ICP, AA, Wet chemistry and physical properties testing., • Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis., • Must understand and apply cGMP requirements applicable to quality control laboratory., • Must have ability to apply technical skills to troubleshoot and resolve analytical and instrument-related problems., • ISO 17025 experience a plus. Physical Requirements of the Position: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch; talk, hear, and smell. This position requires the ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc. and to lift up to 30 pounds. Specific vision requirements including reading of written documents, visual inspection (including color spectrum) of materials and use of computer monitor screen frequently. Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

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

Job DescriptionQuality Assurance Manager (Compliance)Allendale, NJ The Manager, Quality Assurance manages the PPU support unit services of the QA Department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. • The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes., • Start-up Compliance arm of the Quality Assurance Department., • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality AgreementsREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Travel may be required, • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. https://bit.ly/3ip50KK

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

Job Description 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 DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust 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 responsibilitiesSupervisory Responsibility; Direct reportsWhile 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.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.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.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.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.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 work during the weekend, holidays and as required by the companyMust 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 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 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 DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional weekends, nights, and/or holidays as required/necessary.May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.Must be able to handle the standard moderate noise of the manufacturing facility.Must be able to work in open floor plan environment and may work in close proximity to others.Wheel-o-Vator available for use.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job 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 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 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 DescriptionJob Title: Validation EngineerJob Description This role focuses on developing and executing validation, cleaning, and environmental control strategies within regulated cleanroom manufacturing operations. The Validation Engineer supports multiple high-profile, novel product lines in the life sciences space, including advanced tissue regeneration and innovative wound care hydrogel products. The position plays a key role in ensuring compliant, robust, and efficient validation of manual cleaning, sterilization, and environmental monitoring programs while serving as a technical liaison with internal teams and external customers. Responsibilities • Develop and execute validation protocols for manual cleaning processes, clean-in-place (CIP) systems, autoclaves, and heat sterilization to ensure they meet regulatory and internal quality requirements., • Create, implement, and refine cleaning and disinfection protocols that support consistent contamination control across manufacturing and cleanroom operations., • Plan, perform, and document ISO 5–8 cleanroom qualification activities, including initial qualification and ongoing operational readiness assessments., • Implement and maintain comprehensive Environmental Monitoring Programs, including sampling strategies, data review, and reporting to ensure a controlled manufacturing environment., • Contribute to the development and execution of contamination control strategies, aligning procedures and controls with current regulatory expectations and industry best practices., • Lead the environmental program for assigned projects, including coordinating activities, driving continuous improvement, and ensuring alignment with overall quality and validation strategies., • Serve as a primary customer interface for environmental and validation topics, communicating technical information clearly and professionally to external stakeholders., • Collaborate closely with cross-functional teams, including internal engineers, quality, manufacturing, and external consulting partners, to support validation activities and project milestones., • Support validation activities within cleanroom operations, including protocol drafting, execution, data analysis, and final reporting in a regulated manufacturing environment., • Ensure all validation and environmental monitoring activities comply with applicable regulatory standards and internal procedures, including FDA, ISO, and other relevant life science and medical device regulations., • Participate in troubleshooting and root cause analysis related to environmental excursions, contamination events, or validation failures, and support the implementation of corrective and preventive actions., • Maintain clear, accurate, and audit-ready documentation for all validation, cleaning, and environmental monitoring activities.Essential Skills, • Bachelor's degree in Engineering, Quality, or a related technical discipline., • Experience supporting validation in cleanroom operations, contamination control, and environmental monitoring within a regulated manufacturing environment., • Hands-on experience with cleaning validation and the development and execution of validation protocols for manual cleaning, CIP, autoclaves, and heat sterilization., • Understanding of regulatory standards within manufacturing environments, including those applicable to pharmaceutical, medical device, FDA-regulated, and broader life science operations., • Working knowledge of relevant regulatory and quality standards, including FDA requirements and ISO standards applicable to cleanroom and environmental control programs., • Experience with ISO 5–8 cleanroom qualification and maintaining operational readiness., • Background in implementing and supporting Environmental Monitoring Programs and contamination control strategies., • Customer interfacing experience, with the ability to communicate technical validation and environmental information to external stakeholders in a clear and professional manner., • Strong familiarity with validation protocols, documentation practices, and data integrity expectations in regulated environments.Additional Skills & Qualifications, • Experience in pharmaceutical, medical device, or broader life science manufacturing environments., • Exposure to novel or advanced product lines, such as tissue regeneration or wound care technologies., • Ability to work effectively with external consulting firms and integration partners on complex validation and environmental projects., • Strong collaboration skills for working across engineering, quality, and manufacturing teams., • Comfort interpreting and applying multiple regulatory and quality frameworks, including FDA guidance and various ISO standards., • Attention to detail and a systematic approach to validation, documentation, and environmental monitoring activities.Work Environment The Validation Engineer works within regulated cleanroom manufacturing environments, including ISO 5–8 classified areas, supporting advanced life science product lines. The role involves close collaboration with a small, focused project team, including other engineers and consultants who support key initiatives. The engineer partners with an external consulting firm on one of the major projects and regularly interacts with end customers to address environmental and validation topics. The position centers on hands-on validation, environmental monitoring, and contamination control activities in a setting that emphasizes regulatory compliance, technical rigor, and innovation in products such as tissue regeneration solutions and wound care hydrogels. Job Type & Location This is a Contract position based out of Paramus, NJ. Pay and Benefits The pay range for this position is $50.00 - $70.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Paramus,NJ. Application Deadline This position is anticipated to close on Aug 13, 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing 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 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.

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 including a paid Year-End Shutdown., • Career Development, Progression and Training, • Flexible Work Arrangement Programs Applications will be accepted until July 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 Financial Controller Fairfield, NJ (Onsite) Garonit Pharmaceutical is seeking a Financial Controller to lead financial operations across our manufacturing business. This role oversees US GAAP reporting, tax compliance, payroll, and provides strategic financial insights to executive leadership. What You’ll Do • Lead budgeting, forecasting, and monthly financial reporting (US GAAP), • Manage general ledger, reconciliations, and month-end close, • Oversee AP/AR, cash management, and banking relationships, • Ensure federal (IRS) and NJ state tax compliance, • Administer multi-state payroll (W-2s, commissions, withholdings), • Drive inventory costing and manufacturing variance analysis, • Support audits, internal controls (SOX), and financial governance, • Provide financial insights to support business decisions What We’re Looking For • Chartered Accountant from Institute of Chartered Accountants of India (ICAI) is required, • CPA required, • Bachelor’s degree in Accounting or Finance, • 5+ years minimum of US GAAP accounting/financial management experience, • Experience with multi-entity reporting and consolidations, • Background in manufacturing or FDA-regulated environments preferred Key Skills • Strong financial analysis, forecasting, and budgeting expertise, • Experience with ERP/accounting systems (SAP, QuickBooks, Tally), • Advanced Excel skills (Pivot Tables, VLOOKUP, etc.), • Payroll systems experience (ADP, Paychex, Gusto), • Knowledge of SOX 404/internal controls is a plus Additional Information • Exempt, salaried position, • Schedule: Monday–Friday, 8:00 AM – 5:00 PM, • Opportunity to oversee accounting/payroll staff

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 DescriptionAssociate Director, Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Operations is responsible for efficient utilization of Operations resources to meet customer demand. This role will be responsible for maintaining and overseeing the site Operations scheduling and training capacities for a time period looking ahead to the next 3-6 months. The Associate Director, Manufacturing Operations will understand upcoming needs and constraints and help drive strategy accordingly. This includes the management of all Operations scheduling, training and compliance resources. The Associate Director, Manufacturing Operations is also responsible for assessing the needs of the company to contribute to the big picture by ensuring daily operations run smoothly and as efficiently as possible. 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. • Meeting client process demands through planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contracts, • Looking out 3-6 months to ensure capacity and availability of resources (room/equipment/staff) to perform clinical manufacture for processing needs, • Manages all training and compliance activities in the Operations organization, • Responsible for creating, enforcing and measuring Operator training schedules in order to ensure that all production schedules can be carried out, • Creates and maintains a process to ensure that personnel schedules are being accurately and fairly assigned to all Associates, • Supporting and driving special long-term projects and identified and assigned by the PPU Head, • Responsible for creating maintaining and communicating all Operations based KPI’s, • Ensuring department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices, • Approving job specific curriculum for the training and professional development of department staff, • Responsible for streamlining the batch record review process, • Responsible to understand the profit and loss for the PPU’s as well as all related documentation, and how these items impact Operations, • Driving continuous improvement, • Liaison with support groups for short- and medium-term needs – Supply Chain, Training, Quality Systems, Quality Assurance, Quality Control, and others, • Set team expectations and goals and assists in delivering the business direction for the PPU, • Aligning departmental goals, processes and resource allocation with the organizational strategy, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Direct reports: Associate Manager Training, Associate Manager, Compliance, Scheduling Associate, Quality Engineer Associates. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. REQUIREMENTS, • Bachelor's degree (i.e. Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-10 years of cGMP environment, aseptic processing, mammalian cell culture, monoclonal antibody, cell processing, cryopreservation or similar experience., • 5-10 years of leadership experience or equivalent combination of experience., • Deep Understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (able to work with Microsoft Office and corporate scheduling system), • Competencies/Candidate Profile, • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Flexible and able to adapt to company growth and evolving responsibilities, • Accountability, integrity, and strong dedication to regulatory compliance, • Strong business and personnel management acumen, • Strong emotional intelligence, • Ability to think strategically and tactically (detail-oriented), • Strong analytical and problem-solving skills, • Strong written and verbal communication skills, • Drive to create and maintain order in a fluid, technically complex environment, • Continuous improvement mindset, • Ability to multi-task is essential, • Must have the ability to work in a team-oriented environment and with clients, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.Duties, responsibilities, and activities may change at any time with or without notice

Job Description Job Title: Aseptic Technician - 2nd Shift Job Description Join our team as an Aseptic Technician, where you will play a crucial role in maintaining the highest standards of cleanliness and sterility in our cleanroom environment. You will be responsible for washing glassware and medical components, performing aseptic cleaning, and ensuring compliance with GMP guidelines. This position offers growth potential and the opportunity to work in a dynamic and expanding laboratory setting. Responsibilities • Wash glassware and medical components using designated equipment., • Work in an ISO-6 & 7 cleanroom environment while wearing required PPE., • Perform aseptic cleaning and maintain aseptic samples., • Monitor process systems and equipment for proper operation., • Perform daily and weekly preventative maintenance tasks and assist the maintenance team as needed., • Participate in safety committees and adhere to all safety rules and regulations., • Accurately complete required documentation for all tasks., • Clean, sanitize, and disinfect workstations before and after use with attention to detail and high work accuracy., • Perform additional tasks as assigned by the supervisor., • Be assigned different processes depending on the client/project they are working with. Essential Skills • Experience with aseptic techniques and sterilization., • Understanding of GMP and pharmaceutical operations., • Experience in laboratory and cleanroom environments., • 1-2 years of industry experience, preferably in sterile processing., • Punctuality, flexibility, and a strong work ethic. Additional Skills & Qualifications • Previous GMP and SOP experience., • Pharmaceutical/GMP industry background., • Good documentation practices and ability to handle batch records/reviews., • Basic computer skills for using the internal database. Work Environment Work in ISO level 6 & 7 cleanrooms, requiring gowning for 6-10 hours at a time with breaks in between. The position is for the 2nd shift, Monday–Friday, 2pm-10:30pm. Enjoy the opportunity for growth within the company and be part of a lab expansion. Job Type & Location This is a Contract to Hire position based out of Fairfield, NJ. Pay and Benefits The pay range for this position is $23.00 - $24.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Fairfield,NJ. Application Deadline This position is anticipated to close on Aug 6, 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing 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 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.

Client Overview:\n \n Our client is a cosmetics and personal care manufacturer committed to delivering high-quality products while maintaining the highest standards of safety, compliance, and continuous improvement. They are looking for a Quality Manager (Temp) to join their team for 3 - 6+ months. \n \n Salary/Hourly Rate: \n \n $55/hr - $70/hr \n \n Position Overview:\n \n The Quality Manager (Temp) oversees the Quality Management System and leads Quality Assurance and Quality Control operations. This role ensures compliance with FDA regulations, cGMP, ISO standards, and customer requirements while partnering with Operations, Manufacturing, and R&D to drive product quality and continuous improvement. \n \n Responsibilities of the Quality Manager (Temp):\n\n • Manage the Quality Management System (QMS).\n, • Oversee QA/QC activities, including incoming inspection, finished goods testing, and product release.\n, • Lead CAPA, customer complaint, deviation, and nonconformance investigations.\n, • Manage document control, change control, validation, and quality training.\n, • Support customer, supplier, and regulatory audits.\n, • Monitor quality metrics and implement continuous improvement initiatives.\n, • Supervise and develop Quality team members.\n, • Ensure compliance with FDA, cGMP, ISO, and internal quality standards.\nRequired Experience/Skills for the Quality Manager (Temp):\n\n, • 6+ years of quality experience in cosmetics, personal care, OTC, pharmaceutical, or related manufacturing.\n, • The Quality Manager (Temp) should have 3+ years of leadership experience.\n, • Strong knowledge of FDA regulations, cGMP, ISO, CAPA, audits, and Quality Systems.\n, • Excellent problem-solving, communication, and leadership skills.\nPreferred Experience/Skills for the Quality Manager (Temp):\n\n, • Cosmetic or personal care contract manufacturing experience.\n, • Lean, Six Sigma, or continuous improvement experience.\nEducation Requirements:\n\n, • Bachelor's degree in Biology, Chemistry, or a related Science is required.\nBenefits:\n\n, • Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).\nJob Wrapping ID: #LI-AJ3\n \n About Atrium: What you do matters. Guided by our Applicant-Centric™ approach, we foster an environment of collaboration, high performance, and innovation where your talents are valued, and your achievements are celebrated. Join us and become part of an inclusive team committed to your growth and success. By applying to this job, you agree to receive calls, AI-generated calls, text messages, and/or emails from Atrium and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to opt out on any message you receive. For more details, please review our Terms of Use and Privacy Policy . As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.\n \nEOE/M/F/D/V/SO \n \n \nPosition ID: 401061

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. We are committed to supplying innovative medicines that result in meaningful improvements in patients' lives. Our commercialized products include BYFAVO®, BENDEKA®, BELRAPZO®, TREAKISYM®, and PEMFEXY® and our oncology pipeline includes product candidates we believe have the potential to provide greater access within underserved therapeutic areas. Additional information is available on Eagle’s website at www.eagleus.com. Eagle is looking for a motivated VP, Counsel and Compliance to provide strategic legal guidance for our commercial and medical teams. • Serve as the company’s primary legal advisor for commercial and medical teams, • Draft, review and negotiate contracts, vendor agreements and partnership agreements, • Oversee Eagle’s Corporate Compliance Program, including review and revision of policies, auditing and monitoring for compliance with corporate compliance policies, • Prepare training materials and conduct training with sales and corporate employees, • Investigate compliance complaints, • Conduct training with sales and corporate employees, • Coordinate review and implementation of grants and corporate sponsorships, • Coordinate and prepare for quarterly Compliance Committee and Grant Committee meetings, • Coordinate and oversee Sunshine Act data collection and submissions, • Provide legal and compliance support for government pricing submissions, • Perform other job-related duties as assigned, • Minimum 10 years of experience in the pharmaceutical industry, • Sitting and working at a desk for extended periods of time, • 401(k) matching, • Health, dental and vision insurance, • Flexible spending and health savings accounts, • Paid time off Hybrid schedule, 3-4 days onsite/1-2 days remote. This position is based at our headquarters in Woodcliff Lake, NJ, with occasional travel as needed. Please email resumes to jobapplicants@eagleus.com . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. #J-18808-Ljbffr

Job DescriptionFull-Time & PRN Opportunities Available in North Jersey - Clifton, Paramus, and Edgewater, NJ!Monday – Friday and rotating Saturdays | Day Shift between 7:00 AM - 7:00 PMMust be flexible to support market needs. Days and locations may be subject to change. Are you a skilled and compassionate Nurse Practitioner looking for an opportunity to make a meaningful impact in patient-centered infusion care? IVX Health is seeking an NP to provide high-quality, specialized infusion therapy in an outpatient setting. As a Nurse Practitioner at IVX Health, you'll be at the forefront of delivering personalized, compassionate care to our patients. With your expertise in infusion therapy, you'll oversee patient care, collaborate with a multi-disciplinary team, and serve as a trusted resource for patients, families, and providers. You'll ensure every treatment is delivered with precision and care, making a real difference in patients' lives. Why Join IVX Health • Make a Meaningful Impact – Deliver high-quality care that directly improves patients' lives and supports their families., • Collaborative & Supportive Team – Work alongside a dedicated, multidisciplinary team in a positive and patient-focused environment., • Grow Your Career – Access Continuing Education Units (CEUs), tuition reimbursement, and professional development opportunities. We cover the cost of CRNI (Certified Registered Nurse Infusion) and ONCC (Oncology Nursing Certification Corporation) certifications to support your career advancement., • Advanced Clinical Training – Receive ultrasound IV skills training to enhance your expertise in infusion therapy., • Prioritize Work-Life Balance – Enjoy flexible scheduling, ample PTO, and the ability to truly disconnect and recharge during holidays., • Innovative Outpatient Care – Be part of a cutting-edge healthcare model that prioritizes patient comfort, seamless care coordination, and specialized infusion therapies. What You Will Do • Provide Direct Patient Care – Deliver on-site and virtual supervision while administering infusions and injections with precision., • Conduct Patient Assessments – Perform evaluations, document SOAP notes, and monitor treatment responses., • Educate and Support Patients – Guide patients and families through treatment expectations, potential side effects, and disease management., • Ensure Compliance and Quality – Maintain accurate records in the Electronic Health Record (EHR) system, review nursing documentation, and uphold HIPAA and OSHA standards., • Optimize Clinical Workflows – Assist with chart preparation and treatment planning to streamline patient visits., • Collaborate with Healthcare Teams – Work closely with referring providers and cross-functional teams to enhance care coordination., • Support Operations and Training – Assist in inventory management, prior authorizations, and regulatory adherence., • Flexibility and Adaptability – Work at multiple facilities within a designated market as needed., • Perform Additional Duties – Take on other responsibilities as assigned to support patient care and organizational objectives. What We're Looking For • Active and Unrestricted Licenses – Nurse Practitioner (NP) license and Registered Nurse (RN) license (if required by the state)., • Board Certification – AANP or ANCC certification required., • Life Support Certifications – BLS certification required; PALS certification preferred., • Clinical Experience – Background in an ambulatory infusion center, outpatient specialty clinic, or similar setting is a plus., • Ability to Treat a Diverse Patient Population – Must be able to care for both adults and pediatrics—Family Nurse Practitioner (FNP) preferred., • Strong IV and Infusion Therapy Skills – Experience with specialty biologics, medication management, and emergency response protocols., • Proficiency in Clinical Documentation – Experience with EHR systems and a strong understanding of HIPAA and regulatory compliance., • Exceptional Communication & Collaboration – Ability to work effectively with patients, families, and multidisciplinary teams. Pay is based on factors such as market location, job-related knowledge, skills, and experience, and is benchmarked against similar organizations in our size and industry. It is not typical for an individual to be hired at or near the top of the posted range, as compensation decisions depend on the facts and circumstances of each case. In addition to cash pay, full-time regular employees are eligible for 401(k), health benefits, and other company-provided benefits. North Jersey Area Pay Range$62.75—$70.71 USD About IVX Health IVX Health is a national provider of infusion and injection therapy for individuals managing chronic conditions like Rheumatoid Arthritis, Crohn's Disease, and Multiple Sclerosis. We're transforming the way care is delivered with a focus on patient comfort and convenience. Our commitment to exceptional care extends to our employees as well—we empower our team to thrive while living our core values: Be Kind, Do What's Right, Never Settle, Make It Happen, and Enjoy the Ride. Our Mission: To improve the lives of those we care for by redefining the care experience Our Vision: To be the nation's preferred destination for pharmaceutical care of complex chronic conditions Our Commitment: To deliver an unmatched care experience with a foundation in world class service and clinical excellence Benefits We Offer • Comprehensive Healthcare – Medical, dental, and vision coverage, including prescription drug plans and telemedicine services., • Flexible Savings Options – Choose from Health Savings Accounts (HSA) and Health Reimbursement Arrangements (HRA) to manage healthcare costs., • Supplemental Protection – Accident, critical illness, and hospital indemnity plans to provide additional financial security., • Dependent Care FSA – Pre-tax savings for eligible childcare and dependent care expenses., • 401(k) Retirement Plan – Secure your future with a competitive company match., • Disability Coverage – Voluntary short-term and long-term disability plans to protect your income., • Fertility and Family Support – Resources and benefits designed to support fertility care and family planning., • Life and AD&D Insurance – Financial protection for you and your loved ones., • Counseling and Wellness Support – Free resources to support emotional, physical, and financial well-being., • Education Assistance – Tuition reimbursement and certification support to help you grow in your career., • Continuing Education – Access to a CEU library for ongoing professional development., • Charitable Giving and Volunteer Program – Matched donations and paid volunteer time off to support causes you care about., • Employee Referral Bonus – Earn rewards for helping us find top talent. Note: Benefits may vary by employment type. Contact HR for details on eligibility and coverage. EEO STATEMENT IVX Health is proud to be an Equal Opportunity Employer. We value diversity and are committed to creating an inclusive environment for all employees. IVX Health wants to have the best available people in every job, and we make employment decisions on the basis of business needs, job requirements, individual qualifications, and merit. Equal employment opportunities are provided to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, military and veteran status, age, physical or mental disability, genetic characteristic, reproductive health decisions, family or parental status, or any other legally protected category in accordance with applicable federal, state, or local laws. IVX Health prohibits discrimination, harassment, or retaliation of any kind based on any of these characteristics. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship and all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation benefits, and separation of employment. Privacy Policy

GREAT OPPORTUNITY TO BECOME PART OF THE VITAQUEST FAMILY! Vitaquest International is an industry-leading development and commercialization partner for consumer products in nutraceutical and functional foods. With over 40 years of history, Vitaquest has the market insight, global reach and scale of operations to support emerging and existing consumer brands from the idea to the store shelf with flawless execution in every phase. Today, Vitaquest creates and produces more than 4,000 customer formulas for more than 500 brands in over 40 countries. Vitaquest's employees follow an internal communications plan to encourage productivity and engagement within the organization. This is known as Vitaquest PROUD. We believe that each employee contributes directly to the organization's growth and success. We are looking for individuals who share our innovative spirit and hope will take pride in being a part of our Company. Title: VP of Quality Control Department: Quality Reports To: Chief Executive Officer Position Purpose and Objectives Oversees the operations of the Quality Assurance and Quality Control Departments. Is responsible for ensuring cGMP and Food Safety compliance within the Company. Essential Job Functions Directs All Quality Operations and assumes responsibility for all Quality related matters. Provides guidance and works with various Departments in maintaining cGMP compliance and Food Safety within the Company. Reviews and approves SOP’s, investigations, protocols, test methods, laboratory reports, and other Quality related documents as necessary. Manages Quality supervisors and Managers and prepares performance evaluations as required. Conducts Internal and External Quality audits as required. Qualified in HACCP and FDA 21 CFR Part 111 HARPC Hosts third party GMP certification audits and ensures appropriate corrective actions are conducted. Serves as the contact person and hosts any regulatory agency audits and inspections and provides guidance in responding to any regulatory agency questions or observations. Serves as liaison between Manufacturing and Product Development as required to review results of product testing and to troubleshoot production problems. Evaluates and recommends new testing equipment to support laboratory needs and requirements. Knowledge, Skills, and Abilities Required Experience managing technical services and staff. Demonstrated knowledge of current GMP and Food Safety requirements and regulations. Supervisory Responsibility Directly supervises QA/QC Managers and Supervisors and support staff as required. Working Conditions Inside the Company: Frequent interface with Operations, Product Development, Technical Services, and QA/QC management to discuss Quality related items. Frequent interface with Marketing, and Sales. Outside the Company: Frequent interface with contract laboratories, vendors, consultants, and professional societies. Occasional interface with customers. Minimum Qualifications · College Degree in physical science or related discipline. · Ten to Fifteen years previous Quality Management experience. · Experience with QC laboratory operations. · Experience with GMPs in a regulated environment. · Expertise in Dietary Supplements and/or Food/Pharmaceutical Science · HACCP / FDA HARPC Trained and Certified · FSSC22000 Trained · Qualified under FDA FSMA · Internal auditor trained · Working knowledge of Preventative Controls as related to Dietary Supplements Success Factors Strong Leadership skills. Self-motivated team player. Role model to subordinate employees. Well organized and highly professional.

Client Overview Our client is a cosmetics and personal care manufacturer committed to delivering high-quality products while maintaining the highest standards of safety, compliance, and continuous improvement. They are looking for a Quality Manager (Temp) to join their team for 3 - 6+ months. Salary/Hourly Rate $55/hr - $70/hr Position Overview The Quality Manager (Temp) oversees the Quality Management System and leads Quality Assurance and Quality Control operations. This role ensures compliance with FDA regulations, cGMP, ISO standards, and customer requirements while partnering with Operations, Manufacturing, and R&D to drive product quality and continuous improvement. Responsibilities Of The Quality Manager (Temp) • Manage the Quality Management System (QMS)., • Oversee QA/QC activities, including incoming inspection, finished goods testing, and product release., • Lead CAPA, customer complaint, deviation, and nonconformance investigations., • Manage document control, change control, validation, and quality training., • Support customer, supplier, and regulatory audits., • Monitor quality metrics and implement continuous improvement initiatives., • Supervise and develop Quality team members., • Ensure compliance with FDA, cGMP, ISO, and internal quality standards. Required Experience/Skills For The Quality Manager (Temp) • 6+ years of quality experience in cosmetics, personal care, OTC, pharmaceutical, or related manufacturing., • The Quality Manager (Temp) should have 3+ years of leadership experience., • Strong knowledge of FDA regulations, cGMP, ISO, CAPA, audits, and Quality Systems., • Excellent problem-solving, communication, and leadership skills. Preferred Experience/Skills For The Quality Manager (Temp) • Cosmetic or personal care contract manufacturing experience., • Lean, Six Sigma, or continuous improvement experience. Education Requirements • Bachelor's degree in Biology, Chemistry, or a related Science is required. Benefits • Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).

Job Description Overview Amerita, Inc. is a leading provider in home Infusion therapy. We are looking for a Pharmacy Technician - Compounding 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 8:30a-5p 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 • Coordinates and schedules the preparation of sterile mixtures and home medical equipment orders with the assistance of the Pharmacist, • Completes all calculations on product preparation as necessary, • 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, • Participates in branch management, department and intra-departmental meetings and quality improvement activities, • Adheres to all accreditation, OSHA, FDA, state, local and federal regulations, and USP 797 and USP 800 standards relevant to infusion pharmacy and home medical equipment, • 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, • 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, retail or pharmacy setting, preferred, • At least 1 year of aseptic preparation of infusion-related pharmaceuticals in a hospital or home infusion setting preferred, • General knowledge of drug terminology, pharmaceutical calculations, drug use and aseptic techniques, • Flexible schedule with the ability to work on-call evenings and weekends on an as-scheduled basis, • Effective mathematical and communication skills required, • Basic pharmacy knowledge of reading and interpreting prescriptions, • Ability to work independently, accurately and efficiently, • Valid driver's license 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 ocassionally standing and walking. The physical requirements will be the ability to push/pull and lift/carry 21-30 lbs

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 9a-5:30p 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

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world: • LifeVest, the world's first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death., • HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent., • TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career. As part of our ZOLL CMS Sales Team, you will be responsible for selling our non-invasive wearable cardiac defibrillator system, and other ZOLL products such as our portfolio of cardiac diagnostic services to Health Care Professionals in the hospital and out of hospital setting. This includes the initial sales call as well as support activities to promote consistent use (Local Medical Education Programs, Tradeshows, clinical symposiums and conferences). Call points include: Physicians (Cardiologists, Electrophysiologists, Hospitalists, CT Surgeons etc.), Nurse Practitioners, Physician Assistants, nurses, case managers and administrators. Other duties include selling the value of the ZOLL Patient Management System (ZPM) to clinicians as well as educating HCP's and staff about the types of patients indicated for a WCD and all essential ordering and billing requirements. • Provide customers with relevant clinical data that supports the risk of Sudden Cardiac Death in certain patient types and the role of the WCD in protecting these patients, • Provide customers with relevant clinical, reporting, and technical information that supports the utilization of ZOLL Cardiac Diagnostic products for appropriate patients., • Responsible for sales and supporting activities to drive consistent utilization, • Responsible for achieving assigned sales objectives, • Responsible for selling the value of the ZOLL Patient Management (ZPM) to clinicians as well as educating HCP's and staff about all essential ordering and billing requirements for the WCD, • Maintain database of accounts, prepare and submit reports, • Maintain a yearly and quarterly business plan, • Manage field expenses and submit reports in a timely manner, • Attend key Medical Education Programs, exhibits and conventions, • Become a company expert and resource on both ZOLL products and relevant industry trends, • Master both Customer Centric Selling and Integrity Selling skills, • Maintain a collaborative and professional working relationship with all business partners, • Represent ZOLL in a professional and ethical manner. Always maintain a positive attitude, • Communicate openly and share information with others, • Analyze and report on trends that you observe within your territory, • Ensure all relevant information and documentation is provided to intake and reimbursement to ensure appropriate and timely filing of billing claims, • Maintain credentialing/access to all assigned accounts at all times, • Bachelor's Degree From four-year college or university required, • 3-5 years sales experience in medical equipment sales or specialized/hospital based pharmaceutical sales or 5 years of successful sales experience, with at least one of those years in healthcare sales required, • Cardiology experience preferred, • Valid state driver's license Required, • Ability to be credentialed/have access privileges in all assigned customer accounts., • Documented history of sales success, • Proficient with Microsoft Office Suite, • Must live within the assigned territory, • Internal candidates that do not meet the sales experience criteria above may be hired if they have demonstrated a sustained ability to meet the expectations of a sales role and have been in a sales support role for a minimum of 1 year OR have successfully performed within a Associate Territory Manager role., • This position requires the employee to sit, stand, walk, talk, listen, hear and speak on a regular basis. May occasionally be required to stoop and bend., • Must be able to drive an automobile and may be required to travel by train or airplane as needed., • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • This job is a field-based position. Employee will be responsible for working daily in hospitals, doctors' offices and other medical establishments within the assigned territory. Occasionally may be required work atypical hours (evenings and weekends) based on business needs. ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives. The "at plan" compensation (Base Salary + Variable Incentive Compensation) for this position is: $175,000.00 which includes a base salary of $100,000.00 and commission in accordance with the company's sales compensation plan. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com. Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

With a passion for life join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. The Senior Product Manager (SPM), Cardiovascular is responsible for end-to-end product lifecycle ownership for a cardiovascular product portfolio, from ideation through development, launch, commercialization, and lifecycle management. The role drives portfolio strategy, profitability, and cross-functional execution in a highly regulated medical device environment. Job Responsibilities and Essential Duties: • Define and execute product and portfolio strategy, including multi-generational roadmaps and lifecycle plans., • Own end-to-end product lifecycle: ideation through post-launch optimization and profitability., • Integrate Voice of Customer insights, clinical workflows, and competitive intelligence into product requirements., • Partner cross-functionally with R&D, Clinical, Sales, Marketing, Quality, and Operations., • Lead global product launches and ensure commercial readiness., • Develop business cases and financial justifications; track post-launch performance., • Support long-term Cardiovascular division strategy and growth initiatives., • Mentor and coach Product Managers and Associate Product Managers., • Build Quality into all aspects of work by maintaining compliance with all FDA and Worldwide Quality & Compliance regulations., • Adopt the Beyond Compliance Quality Culture and attend all required Quality & Compliance training. Minimum Requirements: • Bachelor's degree required. MBA or advanced degree preferred., • Minimum 7+ years of experience in medical device, pharmaceutical, or life sciences product management. Required Knowledge, Skills, and Abilities: • Extensive experience in product management within a regulated medical device environment., • Strong strategic thinking, analytical, and financial acumen., • Demonstrated ability to influence cross-functional teams without authority., • Excellent communication and presentation skills. About us: With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: Health, Dental, and Vision insurance benefits 401k plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Short and Long Term Disability Benefits Health and Dependent Care Flexible Spending Accounts Commuter Benefits Parental and Caregiver Leave Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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

Institutional & Specialty Sales Consultant - Stroke/Thrombosis | Paterson, NJ At Bayer, we’re reimagining what’s possible in healthcare—driven by our bold mission of "Health for all, Hunger for none." We’re launching a dynamic Institutional & Specialty Sales team to bring Asundexian, a next-generation stroke prevention therapy, to market. You, as a Pharmaceutical Sales Representative will have a rare opportunity to shape access, accelerate clinical adoption, and play a pivotal role in a high-profile neurology launch—delivering innovation to patients when it matters most.At Bayer, we’re reimagining what’s possible in healthcare, driven by our mission: Health for all, Hunger for none. Join a new pharmaceutical sales team, focused on institutional and specialty providers in the areas of stroke and thrombosis. This is a rare opportunity to build an innovative commercial organization from the ground up.This role will cover the geography of Paterson, NJ and candidates must be domiciled within the territory. Why Join BayerShape a collaborative, growth-oriented culture where everyone contributes from day one;Access top-tier compensation, healthcare coverage, and financial security programs—including a 401(k) with up to 10% company contributions, Employee Stock Purchase Plan, and Retiree Medical Account;Receive exceptional family support, including paid parental leave, fertility benefits, and adoption support;Employee discount on all Bayer Consumer Health products;Robust Performance-driven quarterly incentive;Bayer was named one of Fast Company magazine’s Most Innovative companies in Medicines and Therapeutics in 2026;We are committed to investing in digital tools to allow our team to work smarter and to harness the power of AI. As an Institutional & Specialty Pharmaceutical Sales Consultant, you will:Drive clinical demand, education, and sales by communicating the value of Asundexian in stroke prevention;Lead formulary access by navigating P&T committees and influencing protocol adoption across health systems;Build strategic relationships with priority institutions, including key stakeholders at the institutions (i.e., C and D Suite and Head of Pharmacy, Head of Quality), and neurologists;Develop territory business plans based on local market insights and collaborate with internal teams to support a successful launch;Demonstrate expertise and knowledge of disease state, the marketplace, competitors, industry, and cross-functional activities/plans, as well as possessing the analytical rigor to anticipate and identify business opportunities and challenges;Analyze competitive landscape and proactively identify opportunities and risks.Required QualificationsBachelor's degree or 10 years of relevant sales experience in competitive landscapes in lieu of a Bachelor's degree;Experience selling into hospitals, health systems, or institutional accounts;Strong communication, presentation, and stakeholder engagement skills;Ability to meet customer credentialing and safety requirements;Valid driver’s license with a clean driving record.Preferred QualificationsAdvanced degree (Life Sciences, Pharmacy, Business, or related field);Proven success in biotech, medical, or pharmaceutical sales in competitive environments, including experience launching new products and product indications; Deep understanding and significant experience working in stroke, anti-coagulation, neurology, and cardiovascular therapeutic areas;Experience selling in institutional and clinical settings, and navigating the P&T committee process;Experience in establishing and pulling-through in-patient to out-patient protocols.Employees can expect to be paid a salary between $124,320 - $186,480. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.This posting will be available for application until at least 6-5-26.#LI-US#LI-AMSYOUR APPLICATIONBayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.Bayer is an E-Verify Employer.Location:United States : New Jersey : Paterson Division:Pharmaceuticals Reference Code:870508 Contact UsEmail:hrop_usa@bayer.com

Job DescriptionTitle: Labeling Associate Reports to: Line leader/Production Supervisor Department: Operations – Production Management Responsibility Summary: The Labeling Associate is responsible for the accurate creation, verification, and application of shipping, compliance, and different kind of labels for finished goods shippers. A key accountability of this role is owning pre‑labeling readiness—ensuring all customer‑specific labeling requirements, approved templates, documentation, and materials are reviewed, verified, and available prior to production start. This position plays a critical role in ensuring GMP compliance and preventing labeling errors that may lead to regulatory risks or product recalls. The Labeling Associate supports production efficiency while maintaining high standards of quality, accuracy, and safety. Responsibilities: This role supports the Production/Packaging department through: • Leads pre‑labeling activities for multiple customers, following individual customer requirements and approved specifications, • Ensures labeling accuracy, traceability, and reconciliation in accordance with GMP regulations (including labeling controls), • Performs line clearance, label verification, and proper documentation to prevent mix‑ups and compliance risks, • Maintains records according to Data Integrity (ALCOA) principles, • Supports internal, customer, and regulatory audits related to labeling and packaging, • Maintain a high level of accuracy in labeling to ensure compliance with GMP and regulatory requirements, • Support on-time production schedules by ensuring labeling readiness and minimizing delays., • Apply labels to products, components, and finished goods using manual and/or automated labeling equipment in accordance with batch records and work orders., • Verify label accuracy including product name, lot number, expiration date, and regulatory information to ensure compliance with GMP and customer requirements., • Perform in-process checks to confirm labels are legible, properly aligned, and free of defects. Report discrepancies to supervisor or Quality team., • Assist with line clearance activities to ensure correct labels and materials are used for each production run., • Monitor label stock levels and coordinate with supervisors to ensure sufficient materials are available for production., • Work closely with Production, Quality Control, and Warehouse teams to resolve labeling issues and maintain workflow efficiency., • Follow all safety guidelines and maintain a clean, organized work area in compliance with company policies., • Follow all safety policies, SOPs, and quality system requirements, • Assist with packaging, filling, palletizing, and other production-related tasks as needed. Qualifications: • High School Diploma or equivalent preferred, • 1–2 years of experience in a manufacturing, packaging, or production environment preferred, • Experience in cosmetics, OTC, or pharmaceutical manufacturing is preferred, • Ability to perform tasks with a high degree of accuracy in a GMP-regulated environment, • Basic computer skills (label printers, barcode systems, or ERP systems preferred Required Skills: • Strong attention to detail and accuracy, • High level of responsibility and ownership over labeling accuracy, • Good communication and teamwork skills, • Ability to follow written procedures and batch records, • Ability to proactively identify and resolve pre‑labeling issues before issue impacts production or compliance., • Ability to work in a fast-paced, deadline-driven environment, • Ability to stand for extended periods and perform repetitive tasks, • Ability to work in a production floor environment (noise, PPE, etc.), • Ability to lift up to 25 lbs as needed Compensation: The approximate pay range for this position is $ 16.00 - $17.50 per hour. This is a full-time position. 5 days per week (M-F) from 6:30 AM to 3:00 PM at Totowa, NJ Benefits • Medical, Dental, Vision, • Life/AD&D Insurance, • Paid Time Off (PTO), • Special Paid Leave for employees’ personal events, • Company Paid Holidays, • 401(k) with employer match, • Year-End Gift Powered by JazzHR Tnhe4Nw75x

Job Title: Clinical Data Coordinator Job Description The Clinical Data Coordinator plays a key role in supporting clinical research studies by maintaining essential study documents, entering and verifying data on Case Report Forms, and ensuring strict compliance with regulatory and protocol requirements. This position combines meticulous data management with hands-on involvement in specimen processing and regulatory documentation, contributing directly to high‑quality clinical research outcomes in a fast‑paced, high‑volume environment. Responsibilities Maintain essential study documents and regulatory binders for clinical research studies in accordance with FDA guidelines and institutional policies. Enter accurate and complete data onto paper and electronic Case Report Forms (CRFs), ensuring all study-specific data points are correctly captured. Prepare reports and assist with statistical analysis, including enrollment logs and other tracking tools that support institutional statistical review. Ensure timely submission of research data, laboratory specimens, and query responses to research affiliates, sponsors, and statistical centers. Assist research nurse coordinators and other team members in preparing for audits conducted by governing agencies, study monitors, and internal affairs. Obtain and maintain valid Dangerous Goods Shipping Certification and adhere to all Federal Regulations for shipping human specimens and biologic agents. Collaborate daily with principal investigators, research nurse coordinators, sponsors, contract research organizations, and other research team members. Obtain patient consent for minimal-risk studies and verify that informed consent is documented before entering any study-specific data. Compare protocol schedules of events to CRFs to ensure accurate capture of required data points and adherence to study timelines. Resolve data queries accurately and within study-specific timeframes, maintaining clear documentation of all corrections and clarifications. Maintain adequate inventory of research supplies and kits necessary for research activities, ensuring materials are current and safely disposing of expired or closed items. Centrifuge human specimens according to study-specific laboratory manuals and process and ship specimens per protocol and regulatory guidelines. Collect, copy, and file research-related documents such as curricula vitae, medical licenses, laboratory certifications, lab normals, and financial disclosures in study-specific regulatory binders, including items required on FDA Form 1572. Ensure regulatory binders remain complete and up to date with all essential study documents throughout the life of each study. Review study-specific follow-up schedules in the protocol and complete follow-up CRFs to maintain timely and accurate patient follow-up data. Report, track, and file off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within required timeframes. Use SAE reporting logs to track receipt, submission, and acknowledgement of off-site SAEs in accordance with protocol requirements. Organize and prepare for all sponsor-related visits, including pre-site initiation, site initiation, routine monitoring, close-out visits, internal audits, and sponsor audits. Lift a minimum of 5 lbs., push and pull a minimum of 10 lbs., and stand for at least 4 hours per day as required by research activities. Sit and concentrate at a computer workstation for a minimum of 4 hours at a time to complete data entry, reporting, and documentation tasks. Identify the needs of the patient population served and modify communication and interactions to be appropriate for age, culture, language, and any hearing or visual impairments. Communicate effectively with patients, parents, and primary caregivers at their developmental, educational, and literacy level to support understanding of study-related information. Adhere to organizational competencies and standards, including ethical conduct, quality, safety, and compliance expectations. Maintain regular professional contact with medical center personnel, patients, and visitors to support smooth study operations and patient-centered care. Essential Skills Minimum of 2 years of clinical research experience; internship or school-based clinical research experience is acceptable if it involves real clinical exposure. Bachelor's degree, preferably a four-year degree in a science discipline such as Chemistry, Biology, or Nursing. Alternatively, a minimum of 3 years of extensive research experience that includes data abstraction, CRF completion, and research regulatory reporting. Hands-on experience entering data into Case Report Forms for clinical research studies. Demonstrated experience maintaining regulatory binders in compliance with FDA guidelines and institutional requirements. Proven ability to ensure timely submission of research data, laboratory specimens, and query correspondences. Strong attention to detail and accuracy in data entry, documentation, and record keeping. Ability to interpret study protocols and schedules of events and translate them into accurate CRF completion. Capability to resolve data queries within specified study timelines while maintaining data integrity. Comfort working in a fast-paced, high-volume, and high-pressure research environment. Physical ability to lift at least 5 lbs., push and pull at least 10 lbs., stand for at least 4 hours per day, and sit at a computer for extended periods. Effective interpersonal and communication skills for daily collaboration with multidisciplinary research teams and interaction with patients and caregivers. Commitment to regulatory compliance, ethical standards, and adherence to institutional competencies. Additional Skills & Qualifications Oncology research experience, particularly within cancer-focused studies, is highly desirable. Experience working with blood processing, including centrifugation and preparation of specimens for shipment. Clinical research experience in hospital, contract research organization, or pharmaceutical settings is a strong plus. Valid or willingness to obtain Dangerous Goods Shipping Certification. Familiarity with IRB processes, SAE reporting, and use of SAE reporting logs. Experience organizing and supporting sponsor visits, monitoring visits, and audits. Knowledge of FDA Form 1572 requirements and associated documentation such as investigator CVs, medical licenses, lab certifications, lab normals, and financial disclosures. Ability to adapt communication style to meet the needs of diverse patient populations, including varying ages, cultures, languages, and levels of health literacy. Strong organizational skills with the ability to manage multiple studies, deadlines, and competing priorities. * Comfort using electronic data capture systems and standard office software for data entry and reporting. Work Environment This role is based in a cancer center environment with approximately 80 professionals engaged in research activities and a dedicated team of 21 data coordinators. The setting is fast-paced, high volume, and high pressure, requiring the ability to manage multiple tasks and deadlines while maintaining high standards of accuracy and compliance. The team culture is collaborative and supportive, welcoming hard-working individuals who integrate quickly and contribute to shared research goals. The position follows a daytime schedule, with an initial training period from 8:00 a.m. to 4:30 p.m., followed by a regular schedule around standard business hours. Work is primarily performed in an office and clinical research setting, involving extended computer use, handling and processing of human specimens according to protocol and safety guidelines, and frequent interaction with clinical staff, patients, and visitors. Job Type & Location This is a Contract position based out of Hackensack, NJ. Pay and Benefits The pay range for this position is $23.00 - $26.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Hackensack,NJ. Application Deadline This position is anticipated to close on Jul 27, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing 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 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.

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.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Sr. Product Manager (SPM), is responsible for contributing to the strategic development of and overseeing tactical implementation of marketing programs designed to maintain brand awareness and contribute to achievement of business objectives for assigned product. This job is responsible for designing, implementing and evaluating the marketing activities of assigned product(s) within a given product line; participates in the review of marketing programs, monitoring performance progress and implementing changes to programs as needed; facilitates the analysis of market data to identify key segment drivers, growth opportunities and business threats; manages relationships with agencies and internal business partners to align communications and strategies across the brand's target audiences and to ensure regulatory/legal requirements are met. The SPM may lead efforts on developing strategies and tactics for one or all of the following key areas depending on brand: Professional/HCP, Patient/Caregiver/Consumer, Key Opinion Leader (KOL) development including advisory boards, speaker bureau and speaker engagements, Managed markets/Key Accounts, Product contract strategies and execution when applicable. Responsibilities: • Contribute to the strategic development and tactical implementation of marketing programs designed to maintain brand awareness; contribute to the achievement of business objectives for assigned product(s)., • Lead efforts on developing strategies and tactics for key areas based on brand (e.g., Professional/HCP, Patient/Caregiver/Consumer, Managed markets/Key accounts), as applicable., • Collaborate with sales teams to align on strategy and execution of brand plans, drive engagement and obtain appropriate input for marketing initiatives and strategies., • Deliver on expectations by contributing to/leading sales meetings and ensuring proper training, product knowledge & direction to the sales team., • Actively participate in the design, implementation and evaluation the marketing activities of assigned product(s) within a given product line., • Assist in reviewing marketing programs, monitoring performance progress and implementing changes to programs as needed., • Gain market insights and measure performance on brand initiatives and programs; Assist in the Key opinion leader (KOL) development., • Partner with internal stakeholders (e.g., managed markets, medical, regulatory), including market research & analytics to identify, implement & drive metrics. Qualifications: • Bachelor's degree in related field (Master's preferred) with 5+ years of relevant experience (e.g., sales, marketing, product management) in pharma/biotech industry., • Oncology marketing experience is required., • OR a combination of equivalent education and experience., • Some experience with medical, legal and regulatory approval process for promotional programs, preferred., • Experience working with PhRMA and Regulatory/Legal guidelines for healthcare provider interactions to ensure compliance., • Experience working with and directing agencies and strategic vendors., • Proven performance in earlier role., • Hybrid: Tuesdays, Wednesdays and Thursdays onsite in Nutley HQ (Mondays and Fridays are work from home days), • Approximately 25% business travel Skills: Communication & Cross-functional Influence, Critical Thinking & Business Agility, Customer Engagement, Marketing Fundamentals, Mentoring/ People Development, Omnichannel Strategy, Product / Business Knowledge, Project Mgmt. / Data Analytics Eisai Salary Transparency Language: The annual base salary range for the Senior Product Manager, Women's Cancer is from: $148,200-$194,500 Under current guidelines, this position is eligible to participate in: Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States.