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Job Description Are you looking to make a positive impact on people’s lives? Oasis mental health is looking to recruit Behavioral Health Technicians for several clinics all over the state to provide treatment to patients suffering from depression. The perfect entry-level role for those who are passionate about mental health and making a difference in people’s lives. We are looking for staff who may have experience in healthcare and/or hospitality, who consider themselves to be personable and should be able to easily connect with patients, make them feel cared for and comfortable within our treatment centers. We are looking to bring in staff who can emphasize a "Patient First" mentality and are willing to learn. The role includes training and certification to directly administer depression treatment to patients with both Spravato and Transcranial Magnetic Stimulation (TMS), and basic front-office responsibilities. We offer competitive compensation packages: -Pay Range: $20-$24 per hour (based on experience/education) -401(k) with company match -Paid time off -Medical/dental/vision benefits -Employee discount You will primarily work out of the "home" office hired for, but could, in cases of emergency, be asked to cover in another location. We are looking for candidates with a flexible schedule that will be able to work 8-hour shifts ranging from 8AM-7PM. Flexibility is key; our clinic hours can vary based on the needs of our patients. Primary Responsibilities include but are not limited to: • Administering TMS and Spravato therapy, in accordance with our clinical guidelines and protocols., • Preparing the TMS device for treatment., • Reviewing all medication & treatment administration information with each patient before treatment sessions., • Monitoring all aspects of TMS and Spravato treatment to ensure patient safety and clinical accuracy., • Taking patient vitals for Spravato treatment., • Providing and collecting informed consent forms before administering any treatments., • Accurately collecting and documenting all information required to submit REMS monitoring forms following each Spravato treatment session., • To benchmark treatment progress, reviewing, administering, and documenting, psychiatric rating scales such as:, • PHQ-9, • MADRS, • BDI, • While remaining within FDA guidelines, Identifying, solving, and overcoming any obstacles or discomfort that could interfere with a patient’s treatment., • Delivering the highest level of quality patient care while demonstrating empathy, active listening, developing trust, and providing support to an already depressed and vulnerable patient population., • Record and treatment session notes and documentation required., • Collaborating with other team members to ensure high quality care for our patients as needed., • Greet patients with a warm welcome as they enter our facility to make them feel comfortable., • Collecting payments from patients for their out-of-pocket responsibility., • Schedule treatments with patients., • Encompass basic knowledge of general insurance and billing procedures to either directly answer or escalate questions from patients as necessary., • Assist with scheduling and various administrative tasks. Preferred Experience and Qualifications: • High School Graduate, • General computer proficiency, experience using Microsoft Office applications and CRM and/or EHR systems., • Knowledge of local insurance payers., • Basic Life Support Certification (Training & Certification will be provided as needed), • Customer Service experience Characteristics Of Our employees: • Always maintain a “patient centric” mentality, • Passionate about mental health and making a positive impact in people’s lives, • Have a strong work ethic, be curious, and eager to learn, • Act and communicate respectfully to our patients and your colleagues, • Detail oriented, • Physically able to stand on your feet for hours at a time

The Director of Quality Assurance & Quality Control (QA/QC) is a critical leadership role responsible for ensuring that all manufacturing processes and products meet regulatory, food safety, and internal quality standards. This position oversees the development, implementation, and continuous improvement of comprehensive QA, QC, and food safety systems that protect product integrity, consumer health, and the company’s reputation for excellence. The Director leads quality teams across inspection, testing, audits, and compliance programs while partnering closely with production, engineering, supply chain, and regulatory teams to drive continuous improvement and risk mitigation. This role ensures adherence to Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), ISO standards, and applicable federal, state, and customer requirements across all manufacturing sites in the United States.*Food Safety – Flavors Only Essential Job Functions: • Lead the development, implementation, and continuous improvement of quality assurance, quality control, and food safety systems in compliance with FDA, USDA, ISO, HACCP, GMP, and other applicable regulatory and customer standards., • Manage and conduct internal, external, and third-party audits and inspections, including SQF, BRC, FSSC 22000, ISO 9001, and customer audits., • Oversee inspection, testing, and monitoring of raw materials, in-process components, and finished products to ensure compliance with specifications and quality standards., • Investigate quality issues, non-conformances, deviations, and customer complaints; implement effective corrective and preventive actions (CAPA)., • Collaborate with production, engineering, and supply chain teams to monitor critical control points, improve processes, and reduce defects and waste., • Lead and mentor QA/QC staff, providing training on quality standards, food safety practices, regulatory requirements, and inspection techniques., • Manage supplier quality programs, including supplier audits, performance monitoring, and continuous improvement initiatives with vendors., • Maintain accurate and compliant documentation, records, and traceability within quality management systems (QMS)., • Analyze quality data, KPIs, and trends using statistical and root-cause analysis tools to drive continuous improvement initiatives., • Stay current on regulatory changes, industry trends, and emerging risks to proactively update policies, procedures, and training programs., • Bachelor’s degree in food science, Microbiology, Chemistry, Engineering, Quality Management, or a related field., • Minimum of 8 years of experience in quality assurance, quality control, and/or food safety within a manufacturing environment., • Strong knowledge of food safety and quality systems, including FDA, USDA, HACCP, GMP, ISO 9001, and relevant third-party certifications., • Proven experience managing audits, compliance programs, and quality teams., • Proficiency in quality tools and methodologies such as root cause analysis, CAPA, statistical process control (SPC), and Six Sigma., • Professional certifications such as Certified Quality Auditor (CQA), Certified Food Safety Manager (CFSM), ASQ Certified Manager of Quality/Organizational Excellence, or similar., • Experience with Lean Manufacturing, Six Sigma, or continuous improvement frameworks., • Advanced degree in Food Science, Quality Management, or a related discipline., • Experience working in a multi-site manufacturing environment., • Familiarity with environmental health and safety (EHS) and OSHA requirements. This role requires strong analytical skills to interpret inspection, audit, and production data and identify risks or improvement opportunities. Effective leadership and communication skills are essential for managing QA/QC teams, leading audits, and collaborating across departments. Technical expertise in regulatory frameworks, food safety principles, and quality standards supports compliant and efficient operations. Problem-solving and continuous improvement skills enable the Manager to reduce defects, improve processes, and enhance overall operational excellence. Physical Demands: Must be physically able to operate a variety of machines which includes a computer, printer, typewriter, facsimile machine, copy machine, calculator, telephone, laboratory equipment, etc. While performing the duties of this job, the employee may handle hazardous chemicals in the laboratory. The employee will be required to wear all appropriate Personal Protective Equipment (PPE) including but not limited to eye protection, gloves, and lab coat. The noise level in the work environment is moderate. Physical demands vary from sedentary to moderately active work to include standing, walking, and reaching for prolonged periods of time, not to exceed 8 hours for any given activity. Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee occasionally works near moving mechanical parts, precarious places and is occasionally exposed to risk of electrical shock. The noise level in the work environment is usually moderate to loud. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Environmental, Health & Safety management system (per ISO 14001 and ISO 45001 standards’ requirements) is established at TAKUS. These systems are continually improved to maintain high standards for both a healthy and safe work environment and the protection of the environment. Every worker in the workplace needs to take account the following while carrying out their work activities: 1) think not only of their own health and safety, but also the health and safety of others; 2) consistently apply environmental considerations to prevent adverse effects to the environment; 3) strictly follow compliance and other obligations, while understanding the consequences of not following them. Salary Range is 135K - 175K

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice () and Terms of Use () . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Senior Operations Management Trainee (Senior OMT) About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: * Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. * Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. * Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. * Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. * Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. * Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: * Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. * 3-5 years of experience leading medium to large teams (20+ direct reports) * Up to 90-100% travel during the Trainee Program * Ability to walk and/or stand for the entire work shift * Willingness to travel and work at various BioLife locations across the country * Ability to work evenings, weekends, and holidays * Have a valid driver's license for the entire duration of the program * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. * Fine motor coordination, depth perception, and ability to hear equipment from a distance * Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: * Associates or Bachelor's Degree * Experience working with SOPs, GDP, GMP, CLIA, and the FDA * Experience working in a highly regulated or high-volume retail environment * Excellent interpersonal, organizational, technical, and leadership skills About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity #LI-Remote BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NJ - Virtual U.S. Base Salary Range: The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - NJ - VirtualUSA - NJ - Deptford, USA - NJ - Egg Harbor Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice () and Terms of Use () . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Senior Operations Management Trainee (Senior OMT) About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: * Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. * Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. * Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. * Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. * Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. * Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: * Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. * 3-5 years of experience leading medium to large teams (20+ direct reports) * Up to 90-100% travel during the Trainee Program * Ability to walk and/or stand for the entire work shift * Willingness to travel and work at various BioLife locations across the country * Ability to work evenings, weekends, and holidays * Have a valid driver's license for the entire duration of the program * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. * Fine motor coordination, depth perception, and ability to hear equipment from a distance * Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: * Associates or Bachelor's Degree * Experience working with SOPs, GDP, GMP, CLIA, and the FDA * Experience working in a highly regulated or high-volume retail environment * Excellent interpersonal, organizational, technical, and leadership skills About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity #LI-Remote BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NJ - Virtual U.S. Base Salary Range: The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - NJ - VirtualUSA - NJ - Deptford, USA - NJ - Egg Harbor Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice () and Terms of Use () . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Senior Operations Management Trainee (Senior OMT) About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: * Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. * Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. * Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. * Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. * Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. * Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: * Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. * 3-5 years of experience leading medium to large teams (20+ direct reports) * Up to 90-100% travel during the Trainee Program * Ability to walk and/or stand for the entire work shift * Willingness to travel and work at various BioLife locations across the country * Ability to work evenings, weekends, and holidays * Have a valid driver's license for the entire duration of the program * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. * Fine motor coordination, depth perception, and ability to hear equipment from a distance * Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: * Associates or Bachelor's Degree * Experience working with SOPs, GDP, GMP, CLIA, and the FDA * Experience working in a highly regulated or high-volume retail environment * Excellent interpersonal, organizational, technical, and leadership skills About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity #LI-Remote BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NJ - Virtual U.S. Base Salary Range: The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - NJ - VirtualUSA - NJ - Deptford, USA - NJ - Egg Harbor Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

Job Description Position: Sanitation Manager Location: Clifton, NJ area Qualifications: • High School diploma or GED (Associate's or Bachelor's degree preferred), • Extensive Knowledge of SQF, BRC, FDA, USDA, OSHA, and MSDS., • Experience keeping areas and equipment in clean and orderly condition to ensure food safety, quality, and continuous production., • Supervises the Sanitation Crew on all shifts. Analyzes problem sanitation areas, researches and resolves any sanitation issues., • Maintains Sanitation programs maintain SQF certification each year with 3rd-party quality audits., • Coordinates the purchase of cleaning products, PPE (Personal Protective Equipment), parts for sanitation equipment and all sanitation supplies., • Ensures plant compliance with sanitation and safety programs: Recordkeeping, SSOP's (Standard Sanitation Operating Procedures), MSS's (Master Sanitation Schedules) and chemical safety., • Works with production, maintenance, and other departments to assure that food products meet the appropriate sanitation and Food Safety requirements., • Bilingual (English / Spanish) is a plus

Job DescriptionLHH Recruitment Solutions is assisting our client in their search for a hands-on Plant Production Manager to lead all production operations, ensuring safe, efficient, and compliant fulfillment of gas orders (industrial, medical, laboratory, and specialty gases). This role drives production performance, leads a high-performing team of nine employees, oversees quality and regulatory standards, and ensures smooth day-to-day plant operations. Key Responsibilities • Plan, lead, and coordinate daily production operations to meet cost, quality, safety, and ISO 9001 standards., • Oversee production scheduling, inventory needs, staffing, and workflow to ensure timely order fulfillment without delays or backorders., • Hire, train, and develop a cohesive, high-performing team; provide coaching and performance feedback., • Maintain accurate production documentation, daily fill logs, certifications, and regulatory records., • Monitor and enforce product quality and gas purity standards., • Coordinate cylinder testing, shipping, maintenance, and equipment replacement., • Serve as backup for Lab Technician and Dispatcher; assist with cylinder filling and deliveries as needed., • Maintain and update ISO policies, procedures, and process documents., • Manage supply levels, spare parts, and equipment repairs., • Oversee plant assets and monthly production (approx. 30,000 cylinders). Qualifications, • Associate degree or technical diploma in Mechanics, Plumbing, Engineering, or related field., • Minimum 3 years of industry experience, including 1+ year in a supervisory role., • Strong knowledge of production operations, equipment, safety regulations (DOT, OSHA, FDA), and quality control., • Proficient in MS Office; strong problem-solving, leadership, and communication skills., • Valid driver's license; required to have applicable OSHA, DOT, and FDA certifications., • Leadership skills: the ability to provide direction, set goals, give feedback and identify opportunities for development, • The ability to listen to and understand information and ideas presented verbally and in writing., • The ability to convey information clearly and effectively verbally and in writing, • Dependable. Strong customer orientation, • Bilingual Spanish a plus Work Environment, • Mix of office and plant floor exposure (noise, fumes, temperature extremes, industrial equipment)., • Six-day operational schedule; rotating Saturday schedule when needed., • On-call availability 7 days per week for hospital service needs. Benefit offerings for full-time employment include 10 paid Holidays, and 15 PTO days, prorated based on hire date within the calendar year. Also included: Medical, dental, vision, term life and AD&D insurance, long-term disability, employee assistance program, onsite gym, and a 401k plan. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: · The California Fair Chance Act · Los Angeles City Fair Chance Ordinance · Los Angeles County Fair Chance Ordinance for Employers · San Francisco Fair Chance Ordinance Pay Details: $90,000.00 to $95,000.00 per year Search managed by: Edwin Moreno Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: • The California Fair Chance Act, • Los Angeles City Fair Chance Ordinance, • Los Angeles County Fair Chance Ordinance for Employers, • San Francisco Fair Chance OrdinanceMassachusetts Candidates Only: 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.

LabWare LIMS Developer JD Role Overview: Highly skilled LabWare LIMS Developer with strong hands-on experience in designing, configuring, and implementing LabWare LIMS solutions. The ideal candidate will work closely with business and technical teams to deliver robust, compliant, and scalable laboratory information management systems. Key Responsibilities: • Design, develop, and configure LabWare LIMS workflows, templates, and functionalities., • Implement custom scripts and extensions using LabWare scripting language (LIMS Basic)., • Integrate LIMS with instruments, enterprise systems (ERP, ELN), and external applications., • Perform system upgrades, patches, and validation activities., • Troubleshoot and resolve technical issues related to LIMS configuration and performance., • Collaborate with QA, IT, and laboratory teams to ensure compliance with GxP, FDA 21 CFR Part 11, and other regulatory standards., • Create and maintain technical documentation, SOPs, and user guides., • Provide training and support to end-users and stakeholders. Required Skills & Experience: • Strong hands-on experience with LabWare LIMS (configuration, scripting, workflows)., • Proficiency in LIMS Basic scripting and LabWare architecture., • Experience in system integration (instruments, ERP, ELN, APIs)., • Solid understanding of laboratory processes and regulatory compliance (GxP, Part 11)., • Knowledge of SQL, Oracle, or other relational databases., • Excellent problem-solving and communication skills., • Ability to work independently and in a team environment., • Strong, demonstrable experience in LIMS configuration & customization Preferred Qualifications: • Experience with LabWare LIMS v7 or v8.

Job DescriptionSr. Manager/ Associate Director Document & Change ManagementAllendale, NJ The Senior Manager Documentation & Change Management will assist with the overall leadership and implementation of global Document Management and Control and the Change Control Management program designed to comply with applicable laws and regulations. This position has accountability for development and oversight of global quality documents, the structure of the program, and the design, implementation and continuous improvement of electronic document management systems. This position also has responsibility for oversight of the regional Change Management system and accountability for the design, implementation, administration, and continuous improvement of the electronic change management system. • Responsible for the development of systematic control and management processes for GxP documents throughout their lifecycle and for establishing procedures to ensure records (paper and electronic) are maintained in compliance with global regulatory and legal requirements, as well as site requirements and procedures., • Responsible and accountable for the development, deployment and implementation of effective and efficient standards, procedures, and best practices for global and site documentation management and control including periodic review, change process, retention and archival., • Maintains the global Quality Manual and global Quality Standards, and any associated global policies, reports, or documents., • Assists in developing the overall global Quality Standards strategy and implementing the quality documentation hierarchy for global and site documentation, including development of process for gap assessments and implementation planning., • Engages process owners and SMEs to ensure quality standards are appropriately defined, implemented, and/or updated to include current regulatory strategy and are contemporaneous with industry standards., • Leads the development of reporting on quality standards implementation across all functions., • Accountable for development and management of effective documentation system KPIs, metrics, management review, and proactive issue identification and resolution., • Partners, educates, and collaborates with Documentation Control, QA, and SOP authors/owners in other functional areas for the development, deployment and maintenance of the document management program and records retention schedule., • Business process owner for the electronic documentation management system. Partner with IT to implement, administer, maintain, and continuously improve the electronic documentation management system., • Manages the document change request system at the global and regional level and provides guidance at the site level., • Provides support during internal and external audits, including Regulatory Health Authority inspections., • Ensures the documentation system is scalable and flexible to support initiatives and communicates effectively with all cross functional and regional stakeholders on matters related to the documentation system and e-DMS.Change System Management:, • Serves as subject matter expert for the regional change control system and associated requirements., • Develops standards and guidelines for change control inputs and requirements needed to support change control requests., • Oversees and administers the Change Control Board for regional/global Change Control requests and provides guidance at the site level., • Leads the electronic change management governance process and serves as administrator to the e-system., • Interfaces with IT as the Business Process Owner for the electronic change management system. Develops and prioritizes system enhancements and added functionality based on business need., • As needed, works Quality Assurance and functional area representatives or responsible change owners to develop change management strategies., • Develops and provide reports on change management process and progress for global dashboard., • This role may have direct reports. The role also functions as an individual contributor role in a heavily matrixed environment., • Incumbent will be expected to complete all assigned GxP and Compliance related training in accordance with assigned due dates., • Phone conferences outside of normal working hours is required in order to interact with global counterparts., • Travel is required at approximately 15%.REQUIREMENTS, • BA/BS in the Life Sciences is required. MS degree in Life Sciences a plus., • 7-10+ years experience in Document Management and Control and 3-5 years experience in Change Management in FDA-regulated, GxP-related Industry is required., • Comprehensive knowledge of document control principles, data integrity principles, and good documentation practices a must., • Demonstrated experience with implementation and management of electronic document management systems required., • Working knowledge of electronic change management systems or e-QMS required., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Ability to drive Quality projects for continuous improvement., • Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required., • Knowledge of European and Japanese Health Authority requirements is a plus., • Ability to work independently with minimal supervision is required., • Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, and auditors. Proven interpersonal skills with face to face and remote teams., • Position will be filled at level commensurate with experience., • Strong computer skills are required., • Excellent oral, written, and verbal communication skills are 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 DescriptionJob Title: REMOTE Territory Sales Manager – Specialty Chemicals & APIsCompensation: $100,000–$130,000 base + performance incentives Location: Remote (U.S.) Industry: Specialty Chemicals / APIs / Pharmaceutical Intermediates Overview A global manufacturer of specialty chemicals and pharmaceutical ingredients is expanding its North American commercial team. This is a high-impact sales role focused on growth within key verticals including iodine derivatives, intermediates for anti-cancer and contrast media, and active pharmaceutical ingredients (APIs). The role is modeled on a proven sales structure used for similar markets, emphasizing relationship management, business development, and strategic positioning across nutraceutical, pharma, and fine chemical sectors. Key Responsibilities * Drive sales growth across the North American territory for specialty ingredients, vitamins, chemicals and minerals for sports nutrition * Identify, target, and close new business opportunities across the following categories: * Supplement Manufacturers * Contract Manufacturers * * Develop and maintain relationships with key accounts, distributors, and manufacturers. * Collaborate closely with global production and regulatory teams to ensure compliance and delivery. * Analyze market trends and identify high-value prospects for long-term partnerships. * Represent the company at key trade shows and industry events (e.g., IFT, SupplySide West). * Prepare detailed reports and forecasts for executive management. Qualifications * Bachelor’s degree in Chemistry, Chemical Engineering, or related field (advanced degree a plus). * Minimum 5 years of experience in B2B sales of ingredients, vitamins, chemicals and minerals for sports nutrition * Proven track record of achieving revenue goals and building strategic partnerships. * Familiarity with regulated markets (FDA, REACH, GMP) preferred. * Exceptional communication, negotiation, and presentation skills. * Self-motivated, entrepreneurial mindset; able to operate with minimal supervision. Compensation & Benefits * Base salary between $100,000 and $130,000, depending on experience. * Performance-based commission and annual bonus structure. * Health coverage, paid time off, and travel reimbursement. * Long-term growth opportunity with a global chemical leader expanding in the U.S. market.

Job DescriptionPharmacist in Charge About PersonalRx 🌐 PersonalRx is a patient-first, service-driven pharmacy dedicated to improving lives through personalized medication management and reliable home delivery. By combining technology, clinical expertise, and regulatory excellence, we ensure every prescription is filled accurately and on time. Join our growing team and help shape the future of pharmacy care. Position Overview PersonalRx is seeking an experienced and motivated Pharmacist in Charge to lead our East Rutherford, New Jersey pharmacy operations. This role carries full accountability for regulatory compliance, pharmacy operations, and team performance while maintaining a strong focus on patient-centered care. The ideal candidate brings deep pharmacy operations experience, strong leadership skills, and a proactive approach to quality, compliance, and continuous improvement. Key Responsibilities * Serve as the designated Pharmacist-in-Charge (PIC)/ with full accountability for pharmacy operations * Ensure compliance with all New Jersey Board of Pharmacy, state, and federal regulations, including DEA, Medicare, and Medicaid requirements * Lead, mentor, and support a team of 5–10 pharmacists and pharmacy technicians * Partner with the Operations Manager to streamline workflows, improve productivity, and maintain exceptional service levels * Collaborate with executive leadership on strategic initiatives, service expansion, and operational improvements * Manage pharmacy inventory, including procurement, storage, and controlled substance accountability * Oversee quality assurance programs, audit readiness, and continuous process improvement initiatives * Serve as the primary contact for regulatory inspections, audits, and third-party payer reviews * Evaluate, implement, and oversee pharmacy technology systems; ensure staff training and compliance * Resolve escalated patient issues while maintaining a high standard of patient-centered care Qualifications * Doctor of Pharmacy (PharmD) or equivalent degree from an accredited institution * Active, unrestricted New Jersey pharmacist license (required) * Minimum 5–7 years of pharmacy operations experience, including 2+ years in a PIC or leadership role * Strong knowledge of USP, DEA, FDA, and NJ State Board of Pharmacy regulations * Proven experience managing teams and workflows in a complex pharmacy environment * Proficiency with pharmacy management systems and related software * Excellent communication, organizational, and leadership skills * Demonstrated commitment to patient safety, quality, and service excellence Preferred Qualifications * Experience in specialty, long-term care, or mail-order pharmacy * Familiarity with Medicare Part D and third-party payer processes * Strong analytical, reporting, and process-improvement skills Compensation & Benefits * Competitive salary: $135,000 – $150,000 (commensurate with experience) * Paid time off and paid holidays * Professional development support and continuing education reimbursement * Collaborative, mission-driven work culture Why Join PersonalRx? At PersonalRx, you’ll have the opportunity to make a meaningful impact every day—enhancing medication safety, improving patient outcomes, and leading a talented pharmacy team in a supportive, growth-oriented environment. Apply today! A member of our leadership team will review your application promptly. PersonalRx is an EOE Powered by JazzHR 5L1wi41I2r

Job DescriptionTitle: Pre-weigher Reports to: Bulk Manufacturing Manager Department: Operations Responsibility Summary: The Pre-weigh personnel are responsible for the raw material weighing in support of the manufacturing of bulk products. All work requires accurate documentation, performance & adherence to SOPs in order to meet requirements set by our customers & the FDA. Pre-weigh personnel must be detail oriented, with strong basic math skills Responsibilities: The Pre-weigher is responsible for supporting the company's business events through a variety of tasks, including: • Clean, sanitized and calibrate scales at the beginning of each working day., • Complete and verify pre-weigh documentation as required., • Uses scales, computer, and scanners to measure and record raw material transactions., • Operate various material handling equipment to move materials to and from pallet racks., • Follow instructions on pre weigh sheet/batch records, SOP’s, and departmental procedures., • Identify and communicate discrepancies with materials, products or equipment immediately to the manager., • Pull all raw materials by FIFO., • Verify and document all lot numbers that are being consumed in batch., • Maintain a clean and professional personal appearance and working area., • Wear personal protective equipment as required.Qualifications:, • Physical & Other Requirements:, • No allergies or sensitivities to chemicals or required personal protective equipment., • Good overall physical condition., • Able move up to 50 pound bags or drums., • Able to handle full 55 gallon drums., • Able to work independently and as a team member., • Blending and mixing ingredients experience., • Forklift experience a plus., • Demonstrates attention to detail., • Computer literate., • Education Requirements:, • High school education or equivalent,, • Or 1-2 year pre weighing experience., • Good communications skills: speaking, reading, and writing., • Good math skills: addition, subtraction, multiplication, and division., • Language Skills:, • Ability to read, analyze and interpret common weighing procedures, safety rules, operating, and maintenance instructions and procedure manuals of scales. Powered by JazzHR QTBLI5BUp5

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

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

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

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

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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

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

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

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

Job DescriptionThis is a temporary 6-month contracted 1099 position with no benefits. The pay range for this position is $70-$85/hr (depending on prior experience) Job Functions: • Applies expertise as an emerging authority in the mechanical engineering discipline., • Conceives and develops solutions to difficult analytical and pneumatic/mechanical/electrical design problems., • Participates in establishing system or component design objectives and writes portions of complex specifications and engineering reports., • Reviews and helps to develop product specifications, • Conducts conceptual design studies using MCAD and other applicable design tools. Collaborates with other engineering functions, • Develops prototype hardware using internal manufacturing resources and outside vendors, • Tests product to verify that designs meet specification requirements such as environmental, regulatory and safety requirements, • Generates documentation supporting the design, • Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software., • Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable., • Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable., • Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data., • Experience with electronic document control systems in medical device and/or medical equipment design and development., • Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis., • Ability to create and meet scheduled timelines (manage and coordinate tasks as required)., • Ability to work in a team environment., • Strong communication skills., • Familiarity with dimensioning and tolerance, thermal and structural analysis, and vibration testing/analysis, • Intermediate knowledge of FDA, IEC and UL standards relating to medical electronic equipment, • Strong technical and analytical ability, verbal and written communication skills, ingenuity and creativity, interpersonal and project management skills, • Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM’s and oscilloscopes, • BSME or MSME and a minimum of 10 years of related experience in design/product development of electro pneumatic assemblies including technical supervision of sub-projects, • Formal training in basic and advanced topics in Solid Works is strongly preferred, • Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat, • Advanced proficiency with SolidWorks, MCAD/CAE software and database management software preferred, • Advanced proficiency with Microsoft Visio and Microsoft Project preferred Important Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to . Powered by JazzHR QpHnpP1sVI

Job 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 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: This is an individual contributor role that supports the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH, local Regulatory requirements and NS Pharma standard operating procedures. This is a hybrid role that requires employees to come into the office twice a week. Essential Duties and Responsibilities: • Assist in the planning, implementation and management of assigned regional or global clinical studies., • Facilitate CRO./vendor selection process., • Maintain oversight of assigned study vendors (e.g. central labs)., • Perform assigned activities in the selection of clinical sites., • Attend and participate in site visits including pre-study assessments, site initiations, co-monitoring and ad-hoc site visits based on the study’s needs., • Review site visit reports, identify issues and ensure issues are resolved., • Oversight of patient recruitment and development of recruitment strategies and plans., • Track, review, report and present study metrics including enrollment, protocol deviations, issues, risks, data resolution, and other study related metrics., • Support the development of study related documentation (protocol, ICF, CRF, operations manuals, etc.); facilitate internal review of these documents as assigned., • Tracking of clinical data, regulatory documents, and patient, • Assure compliance of investigational sites with SOPs, FDA regulations, ICH guidelines and protocol requirements., • Facilitate internal review of clinical trial agreements and ancillary agreements, • Implement and maintain study-specific training program., • TMF oversight review during study conduct and TMF management during study closeout., • Support creating and maintaining clinical SOPs as part of global QMS., • Perform administrative tasks (e.g. setting-up and facilitating meetings, clinical registrations)., • Thorough understanding of clinical operations including strong knowledge on essential documents as related to the planning, launching, and closing clinical studies, • Must be able to manage and coordinate with the Clinical Lead(s), Study Manager(s), Operations Program Lead and study team members at Headquarters Office in Japan to achieve study objectives and team goals, • Must have the ability to identify and manage/solve study team’s performance issues if they arise with minimal supervision, • Must have demonstrated ability to support the development and management of various aspects of the study operational plans from start-up to close-out., • Must be able to work effectively in a multi-cultural, global team environment and support drug development collaboration with global project teams, Headquarters Office in Japan, external partners and vendors., • Ability to handle multiple tasks and prioritize., • Strong organizational, attention to details, communication and presentation skills., • Team player, flexible, ability to adapt to change, • Ability to interact with Investigators in-person to discuss protocol requirements and study drug., • Bachelor’s Degree in sciences (highly preferred) or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience, • Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials., • Program and project management experience preferred., • Global clinical trial experience is also preferred. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $110,000 to $135,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training, • Flexible Work Arrangement Programs Applications will be accepted until April 30, 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 JOB DESCRIPTION: • The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Companys compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials., • The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience., • This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES: • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials., • Plan and conduct audits of specific clinical processes based on risk., • Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor., • Develop audit reports and distribute them to appropriate stakeholders., • Own and manage related clinical vendor non-conformances., • Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.)., • Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors., • Support the preparation, coordination, and participation of regulatory agency inspections., • Participate in and support quality improvement projects. QUALIFICATIONS: • 5+ years of pharmaceutical experience, • 2+ years of RadioPharmaceutical and Quality Assurance experience, • BS degree in scientific, health care or related discipline, • Intensive GCP and safety background, • Experience with both internal and external process and systems audits, • Strong knowledge of development policies, procedures and standards (SOPs, QMS), • Ability to work with global clinical teams in developing objectives for audits of clinical studies, • 10% Traveling required

Job Description JOB DESCRIPTION: • The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials., • The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience., • This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES: • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials., • Plan and conduct audits of specific clinical processes based on risk., • Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor., • Develop audit reports and distribute them to appropriate stakeholders., • Own and manage related clinical vendor non-conformances., • Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.)., • Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors., • Support the preparation, coordination, and participation of regulatory agency inspections., • Participate in and support quality improvement projects. QUALIFICATIONS: • 5+ years of pharmaceutical experience, • 2+ years of RadioPharmaceutical and, • 2+ years of GCP quality experience, • BS degree in scientific, health care or related discipline, • Intensive GCP and safety background, • Experience with both internal and external process and systems audits, • Strong knowledge of development policies, procedures and standards (SOPs, QMS), • Ability to work with global clinical teams in developing objectives for audits of clinical studies, • 10% Traveling required

Job Description The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company's compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES: • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials., • Plan and conduct audits of specific clinical processes based on risk., • Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor., • Develop audit reports and distribute them to appropriate stakeholders., • Own and manage related clinical vendor non-conformances., • Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.)., • Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors., • Support the preparation, coordination, and participation of regulatory agency inspections., • Participate in and support quality improvement projects. QUALIFICATIONS: • 5+ years of pharmaceutical experience, • 2+ years of RadioPharmaceutical, • 2+ years of GCP quality experience, • BS degree in scientific, health care or related discipline, • Intensive GCP and safety background, • Experience with both internal and external process and systems audits, • Strong knowledge of development policies, procedures and standards (SOPs, QMS), • Ability to work with global clinical teams in developing objectives for audits of clinical studies, • 10% Traveling required

Job DescriptionJOB DESCRIPTION:The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES:Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS:5+ years of pharmaceutical experience Must have experience with Radiopharmaceuticals and Quality BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

Job DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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

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

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

Job Description Manager-Director, Business Development - Clinical Research Manager-Director, Clinical Business Development Full Time Remote-USA Based (Preferably East Coast) Reports to: Senior Vice President, Clinical Services Frontage Laboratories Inc. Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials. Frontage Clinical Services At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion. Position Summary: The Business Development role involves the creation of long-term valued business relationships for the Company with both existing and new customers, with primary emphasis on new account development. The position title can be Business Development Manager to Director depending on experience. Responsibilities: • Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers., • Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes., • Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization., • Ensure appropriate strategy/solution is proposed to clients., • Monitor actions and results against plans., • Lead client visits to the Frontage facilities., • Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities., • Monitor sponsor satisfaction by regular communication with the clients/sponsors., • Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (salesforce) system., • Represent Frontage at trade shows and other meetings. Education, Skills and Experience Required: • BS degree or above, life science preferred., • Must have 2+ years’ experience in selling Pre-Clinical or Phase 1 clinical research services., • Solid understanding of the principles of drug discovery and development., • Knowledge and experience in DMPK & Safety Toxicology, • Knowledge and understanding of FDA, GCP, and ICH regulations and guidance, • Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel., • Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities., • Excellent oral and written communication skills., • Ability to travel., • Established industry client network is a plus. Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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

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

Job DescriptionJOB DESCRIPTION:The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES:Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS:5+ years of pharmaceutical experience 2+ years of RadioPharmaceutical and Quality Assurance experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

Job DescriptionSr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionJOB DESCRIPTION:The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES:Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS:5+ years of pharmaceutical experience 2+ years of RadioPharmaceutical and 2+ years of GCP quality experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

Job 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 DescriptionThis position will report into the Manager of QC Analytical. The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control and technical standards. The QC Analytical Supervisor will also provide oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Schedules and monitors daily operation of department based on projected client demands., • Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices., • Approval of investigations and documentation of non-confirming events and OOS., • Recommends process improvements to achieve greater efficiency within the department and between sites., • Participates in department and cross functional meetings., • Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness., • Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Direct reports: QC Analysts (Approximately 8-10 reports), • Other duties as assigned.REQUIREMENTS, • BS degree in Science or relevant field;, • 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent., • Strong knowledge of FDA and EU regulatory standards. cGMP experience required., • Strong knowledge of analytical test methods and philosophies., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office and LIMS, • Competencies/Candidate Profile, • Acts decisively, • Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively., • Builds and maintains relationships, • Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders., • Communicates effectively, • Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback., • Fosters continuous improvement and innovation, • Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies., • Fosters integrity and honesty, • Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically., • Supervises and manages performance, • Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues., • Manages projects and functions, • Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication., • GxP/GDP TrainingWorking EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Must have the ability to work with specialized equipment.The employee must be able to comply with the company's personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification as well as annual re-qualification as a core competency requirement of their employment in this role. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAbout MMS Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. Applicants must be legally authorized to work in the U.S. for any employer; we cannot sponsor visas (e.g., H-1B) or offer work authorization transfers at this time. Job Specific Skills: • Mastery and trained on generating tables, listings, and graphs from clinical trial databases using SAS., • Utilizes System Development Life Cycle (SDLC) for programming deliverables., • Advanced user in SAS programming, SAS Base, and SAS Macros., • Advanced knowledge of E-Submission Standards, Guidelines and Regulations., • Mastery and trained on SDTM standards including ability to write specifications., • Advanced knowledge of ADaM standards including supporting specification writing., • Proficient with MS Office applications., • Advanced knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements., • Advanced experience with pooling of data sets for submissions., • Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP., • Lead study or small programming project teams.Job Requirements:, • Masters required for all Statistics roles., • Minimum of 5 years’ experience in Statistical Programming or similar field required., • Expert knowledge of scientific principles and concepts., • Reputation as emerging leader in field with sustained performance and accomplishment., • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Excellent problem-solving skills., • Good organizational and communication skills., • Familiarity with current ISO 9001 and ISO 27001 standards preferred., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements. WWrkvz8zoZ

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

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

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

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

Job DescriptionSalary: $165,000-$185,000 Mamas Creations, Inc. (NASDAQ: MAMA) is a leading marketer and manufacturer of fresh deli prepared foods, found in over 8,500 grocery, mass, club and convenience stores nationally. The Companys broad product portfolio, born as MamaMancinis, from a rich history in Italian foods, now consists of a variety of high quality, fresh, clean and easy to prepare foods to address the needs of both our consumers and retailers. Our vision is to become a one-stop-shop deli solutions platform, leveraging vertical integration and a diverse family of brands to offer a wide array of prepared foods to meet the changing demands of the modern consumer. For more information, please visit . We have an excellent opportunity for a highly skilled and experienced leader to serve as the Senior Director, Plant Operations of our East Rutherford facility. You will be the senior site leader responsible for the overall performance, safety, Grandma Quality, controls, culture, and financial results of the manufacturing facility. This role serves as the plants general manager, accountable for translating enterprise strategy into consistent, disciplined execution with excellence at the site level. The Senior Director leads through people, systems, and standards, ensuring production, FSQA, maintenance, warehousing, and workforce leadership operate in alignment with Grandma Quality. This role balances results with responsibility, honoring Mamas heritage while building scalable, sustainable operations. Key Responsibilities • Own end-to-end plant performance, including safety, food safety, quality, service, cost, labor efficiency, and employee engagement., • Own overall plant efficiency and throughput performance, ensuring production capacity, labor models, and operating practices support enterprise targets., • Drive improvement in throughput, yield, and line performance by setting expectations, removing barriers, and holding leaders accountable for results., • Serve as the strategic leader for the site, translating enterprise priorities into clear site-level strategies, initiatives, and execution plans., • Partner with the Senior Manager, Production Operations to ensure production schedules and execution plans support optimal efficiency and service outcomes., • Own the plant operating budget, including labor, overtime, supplies, and controllable costs; ensure performance aligns with financial targets., • Balance cost discipline with Mamas commitment to Grandma Quality, safety, and employee well-being., • Use KPIs and financial data to evaluate performance, prioritize investments, and guide decision-making., • Partner with OpEx/CI to identify and sponsor continuous improvement initiatives that deliver measurable, sustainable gains in efficiency, throughput, and cost performance., • Ensure efficiency gains and cost improvements are sustainable and embedded into standard work and leadership routines., • Lead, coach, and hold accountable all direct reports, site functional leaders, and the downline., • Serve as the primary owner of plant culture, reinforcing values-based leadership, respectful supervision, and consistent accountability., • Ensure site execution aligns with enterprise standards of excellence and Grandma Quality while addressing location-specific risks and opportunities., • Partner with FSQA leadership to maintain strong food safety culture, regulatory compliance, and audit readiness., • Own site-level labor strategy, workforce planning, and performance management in partnership with People Operations., • Drive operational discipline through KPIs, operating practices, and structured problem-solving., • Partner with Reliability & Asset Management to support uptime, preventive maintenance execution, and capital improvements., • Support capital projects, expansions, and equipment installations at the site level., • Participate in operational diligence and integration activities related to acquisitions or expansions impacting the facility., • Serve as the primary escalation point for site risks, performance gaps, and employee relations matters., • Build strong cross-functional relationships that nurture trust, accountability, and pride in workmanship., • Collaborate closely with Senior Directors and plant leaders at other facilities to share best practices, standardize where appropriate, and drive enterprise-wide operational improvement., • Participate in cross-facility working groups, initiatives, and problem-solving efforts to strengthen consistency, performance, and scalability across the enterprise., • Champion collaboration between facilities while respecting site-specific strengths, constraints, and heritage., • Other related tasks, as necessary to drive results and support the business. Qualifications • Bachelors degree in Operations Management, Engineering, Business, or related field; or equivalent experience., • 15+ years of progressive leadership experience in manufacturing operations, preferably in food manufacturing or regulated environments., • 10+ years of experience leading multi-shift operations and managing leaders (managers/supervisors)., • Demonstrated experience owning site KPIs, budgets, labor planning, and operational performance improvement., • Expert usage of ERP systems. NetSuite preferred., • Strong working knowledge of food safety/regulatory environments (USDA/FDA), HACCP, GMPs, and audit readiness expectations., • Proven ability to lead through change while maintaining operational stability and culture., • Strong communication, planning, and cross-functional leadership skills., • Lean/Six Sigma knowledge/certification, preferred., • Bilingual (English/Spanish) highly preferred. Essential Physical Requirements • Ability to regularly walk, stand, and move throughout the manufacturing facility., • Ability to navigate stairs, catwalks, and uneven surfaces safely., • Ability to visually and audibly observe operations and employee practices., • Ability to wear required PPE (hair/beard nets, safety shoes, gloves, safety glasses, hearing protection)., • Ability to work in varying environmental conditions (heat, cold, noise, humidity)., • Ability to sit for extended periods while performing administrative work., • Ability to travel locally as required., • Ability to communicate clearly and effectively. We offer a comprehensive compensation package that includes a base salary (to $185k,) plus bonus eligibility, paid time off, holiday pay, medical, dental, vision, and life insurances, FSA, EAP, and 401(k.)