Pharmaceutical quality control jobs in Wayne, New JerseyCreate job alerts

Job Description Ingenus Pharmaceuticals offers a generous Paid Time Off policy, as well as, 14 paid holidays per year. Medical, Dental and Vision benefits are offered to all associates and are effective on the 1st day of the following month after hire. Enrollment in 401k after 90 days. The Manufacturing Operator/Technician II is responsible for all functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. Major Areas of Responsibility  Execute Batch Record and logbook documentation with clear details and accuracy.  Execute the procedures used to clean pharmaceutical production equipment and facilities.  Operates pharmaceutical production machinery and executes procedures for manufacturing such as dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing etc.,  Executes total changeovers and cleaning.  Identifies and assists in the corrective actions of processing related issues.  Maintains production reporting for assigned work unit operation.  Performs required in-process product quality checks and document accurately.  Execute procedures to complete tasks in a safe, compliant and efficient manner.  Works in collaboration with others as part of a team.  Assists with on the job training of other production trainees and operators.  May determine methods and procedures on new assignments and may provide assistance to other support personnel.  Effectively communicates issues to supervisor.  Adheres to all cGMPs, compliance/regulatory mandates and quality requirements.  Assists in the identification and implementation of continuous improvement opportunities.  Performs other related duties as assigned to meet departmental and Company objectives. Required Knowledge, Skills and Abilities  Knowledge of Metric and English weighing and measurements systems.  Basic understanding of mechanical machinery and the operating principles of control systems.  Demonstrated mathematical ability in addition, subtraction, multiplication, division, ratios and percentages.  Ability to use a calculator.  Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation.  Accurate and precise in recording data and batch information.  Ability to work in both independent and team environments.  Proficient in reading and writing English to understand work instructions and document results.  Ability to operate pharmaceutical processing equipment.  Ability to meet required standards of cGMPs.  Demonstrated understanding of the unit operations and the ability to assist with on-the-job training of manufacturing trainees and operators. Education and Experience  High school diploma or general education diploma (GED).  Two years’ related experience or equivalent technical training/certification preferred; or a combination of related experience and technical training/certification. Physical Demands The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job:  Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear without any aids.  Capable of lifting or carrying and walk with a minimum of 30 kg alone without any support or aid and higher weights with support or aid as required.  Capable of moving the machines, filled containers, and other accessories alone or with support or aid as required.  Work different operational shifts from time to time as required.  Weekends / holidays and extended hours as required.  Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.  Operate trucks and other industrial vehicles to transfer the containers/production equipment.  Manufacturing operator/technician II are expected to operate any industrial machinery such as Forklifts, Hi-Lo, Reach Truck, Hand truck, Pallet Jack, Drum lifter etc. to lift, carry, push, pull or otherwise move objects. Work Environment The work environment characteristics described here are representative of those an individual encounter while performing the essential functions of this job:  Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.  Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.  Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.  Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face (Dust / Mist Respirator & Half-Face Air Purifying Respirator) and full-face negative pressure respirators  Individual may be required to wear hearing protection under certain conditions  Any employee required to use any type of Air Purifying Respirator must not have facial hair and must be cleanly shaven to assure a proper seal. Ingenus Pharmaceuticals LLC. is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, sex, color, religion, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status. Company DescriptionIngenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.Ingenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.

Job Description Job Title: Coating Operator II Department/Division: Manufacturing/Coating Reports to: Manager, Coating About LTS: LTS Lohmann Therapy Systems is a premier, global Contract Development and Manufacturing Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners’ market advantage. Every one of our 1,000 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes. We Care. We Create. We Deliver. Job Summary Lohman Therapy Systems North America is seeking a highly motivated and experienced Machine Operator with a strong focus on coating processes to join our growing team. In this role, you will play a crucial part in the successful production of high-quality products by operating and maintaining various coating equipment, ensuring optimal performance, and maintaining a safe and clean work environment. This is a full-time onsite position located in West Caldwell, NJ • Control and align multiple web paths during manufacturing with tension drive units, pressure rollers, and an edge guiding system., • Perform machine setups and correct machine functions., • Handle raw stock materials with a pallet jack., • Splice materials with a utility knife, tape gun, and splicing table., • Ensure proper disposal of hazardous waste, cleaning solutions, and adhesive compounds., • High school diploma or equivalent., • 4–5 years of machine operator experience, with at least 3 years of GMP manufacturing experience, preferably in the pharmaceutical field., • Experience with coating is preferred., • A strong mechanical aptitude and familiarity with equipment operation., • Strong math skills are a must., • Good reading, writing, and verbal skills., • Good computer skills to navigate systems and fill out necessary forms and documents., • Knowledge of laminating pressures for various types of films, fabrics, and foams., • Knowledge of Corona Treatment. LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job DescriptionCompany Description Derex Technologies Inc specializes in providing IT consulting, staffing solutions and software services. Globally headquartered in Harrison New Jersey since 1996 Derex delivers the highest quality technology professionals and an array of customized IT talent solutions designed to improve productivity and drive results to global clients throughout North America. With over two decades of unparalleled experience, Derex provides supports to its clientele, across such industries as Systems Integration, Banking and Finance, Telecommunications, Pharmaceutical and Life Sciences, Energy, Healthcare, Technology, Transportation, and local and federal Government agencies. Job Description Position: Software Engineer – DevOps Location: Parsippany, NJ (On-Site) Full Time Job Overview Seeking a highly motivated and experienced DevOps Engineer to join our dynamic technology team. In this role, you will be instrumental in building, automating, and maintaining our robust and scalable infrastructure, ensuring our applications and services' smooth and efficient delivery. You will collaborate closely with development, operations, and security teams to streamline our deployment processes, enhance system reliability, and drive continuous improvement. Responsibilities: • Utilize strong Git knowledge for version control, branching strategies, and collaborative development workflows., • Proficiently manage code merges, resolve conflicts, and ensure code quality within the Git repository., • Develop and maintain automation scripts and tools for infrastructure provisioning, configuration management, and application deployments., • Implement and manage continuous integration and continuous delivery (CI/CD) pipelines using industry-standard tools., • Design, implement, and manage our Windows-based infrastructure, including Windows Servers and Internet Information Services (IIS)., • Monitor system performance, identify bottlenecks, and implement solutions to optimize efficiency and reliability., • Troubleshoot and resolve application deployment issues in a timely and effective manner., • Collaborate with development teams to understand application requirements and ensure smooth and efficient deployments., • Implement and maintain security best practices within the infrastructure and deployment processes., • Participate in on-call rotation to support production environments., • Document infrastructure configurations, deployment procedures, and troubleshooting steps., • Stay up to date with the latest DevOps trends, tools, and best practices. Skills and Qualifications • Bachelor’s degree in computer science, Engineering, or a related field., • 5-7 years of experience in DevOps,, • Deep understanding and hands-on experience with Internet Information Services (IIS) configuration, management, and troubleshooting., • Strong scripting skills in PowerShell., • Experience with CI/CD tools such as Azure DevOps, Jenkins, GitLab CI, and similar., • Experience with configuration management tools such as Ansible, Chef, or Puppet (PowerShell DSC preferred)., • Familiarity with cloud platforms such as Azure or AWS., • Experience with monitoring and logging tools (e.g., Dynatrace, Prometheus, Grafana, ELK stack, Azure Monitor)., • Excellent problem-solving and analytical skills., • Strong communication and collaboration skills., • Demonstrated strong knowledge of Git and Git workflows., • Proven ability to effectively manage code mergers and resolve conflicts. Qualifications • Experience as a .NET developer or strong understanding of the .NET development lifecycle and deployment processes., • Experience with containerization technologies such as Docker and orchestration tools like Kubernetes., • Knowledge of security best practices in cloud and on-premises environments., • Bachelor’s or master’s degree in a computer-related field. Key Competencies Communicates effectively– Attentively listens to others, provides timely and helpful information and is effective in a range of professional settings. Gives and receives feedback in a productive, professional manner. Demonstrates excellent oral and written communication skills. Manages Ambiguity -Operating effectively, even when things are not certain, or the way forward is not clear. Is flexible in approach and is able to adapt their approach to meet changing business needs. Manages complexity -Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems. Has strong organizational skills and is able to manage multiple activities at once. Has high attention to detail. Ensures Accountability -Follows through on commitments and makes sure others do the same. Able to work independently as part of a small team. Regards, Manoj Derex Technologies INC Contact : 973-834-5005 Ext 206 Additional Information All your information will be kept confidential according to EEO guidelines.

Job DescriptionCompany Description The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you’re looking for a rewarding career, a place to call home, apply with us today! Job Description POSITION SUMMARY: We have an exciting opportunity to support our client in analytical testing and implementation of novel analytical methodologies for our clients CAR-T cell therapy products. These Scientists will work with a talented and experienced client team in Research and Development and will be important points of contact for the coordination and execution of molecular, potency and characterization assays, qualification studies, and method transfer activities within area of expertise. This team will interface regularly and build relationships with other functions at the client site such as Process Development, Quality Control and Manufacturing Sciences & Technology to collaboratively drive projects to meet the established timelines while maintaining the highest quality and data integrity standards. POSITION RESPONSIBILITIES: • Perform analytical testing including flow cytometry, cell count, cell viability, qPCR/dPCR, ELISA, potency, etc. following appropriate SOPs and procedures. In addition, review and approve data by other team members, • Record and maintain meticulous records in electronic laboratory notebook in compliance with Quality standards, • Identify opportunities for method improvement, • Execute qualification/optimization of analytical methods, • Drive project timelines and deliverables while meeting internal quality and data integrity requirements, • Communicate effectively and present complex data within the department and cross-functionally, • Author and review method related technical documents to ensure completeness, accuracy, consistency and clarity, • Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiencyQualifications BASIC MINIMUM QUALIFICATIONS: • BA/BS or MS in biology, chemistry, biochemistry, microbiology or other related science, plus 1+ year of prior experience in industry or academia., • Understanding of the basic scientific principles underpinning the analytical methods such as flow cytometry, PCR, ELISA, cell-based assays, • Expertise with aseptic technique, • Ability to communicate clearly with internal or cross-functional teams, • Detail-oriented with expertise in problem solving & demonstrated ability to work in a team environment, • Established ability to work in a regulated environment, • Good presentation skills and scientific/technical writing skills, • Understanding of the concepts of cGxP, • Experience with mammalian cell culture, Human T-cell culture, • Experience writing laboratory SOPs and technical instructions, • 1-3 years of experience in pharmaceutical, biologics industry Additional Information Position is Full Time, Monday – Friday First Shift. Candidates currently living within a commutable distance of East Hanover, NJ are encouraged to apply. Excellent full-time benefits include: • Comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match, • Paid vacation and holiday, • Yearly goal-based bonus & eligibility for merit-based increases

Job DescriptionCompany Description The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you’re looking for a rewarding career, a place to call home, apply with us today! Job Description POSITION SUMMARY: We have an exciting opportunity for a Senior Scientist Group Leader to support and lead a team supporting our client in analytical testing and implementation of novel analytical methodologies for our client's CAR-T cell therapy products. This team will work with a talented and experienced client team in Research and Development and will be important points of contact for the coordination and execution of molecular, potency and characterization assays, qualification studies, and method transfer activities within area of expertise. This team will interface regularly and build relationships with other functions at the client site such as Process Development, Quality Control and Manufacturing Sciences & Technology to collaboratively drive projects to meet the established timelines while maintaining the highest quality and data integrity standards. POSITION RESPONSIBILITIES: • Perform analytical testing including flow cytometry, cell count, cell viability, qPCR/dPCR, ELISA, potency, etc. following appropriate SOPs and procedures. In addition, review and approve data by other team members, • Supervise PSS team, • Record and maintain meticulous records in electronic laboratory notebook in compliance with Quality standards, • Identify opportunities for method improvement, • Execute qualification/optimization of analytical methods, • Drive project timelines and deliverables while meeting internal quality and data integrity requirements, • Communicate effectively and present complex data within the department and cross-functionally, • Author and review method related technical documents to ensure completeness, accuracy, consistency and clarity, • Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiencyQualifications BASIC MINIMUM QUALIFICATIONS: • BS in biology, chemistry, biochemistry, microbiology or other related science with 5+ years industry experience or MS and 3+ years of industry experience, • Leadership skills, • Understanding of the basic scientific principles underpinning the analytical methods such as flow cytometry, PCR, ELISA, cell-based assays, • Expertise with aseptic technique, • Ability to communicate clearly with internal or cross-functional teams, • Detail-oriented with expertise in problem solving & demonstrated ability to work in a team environment, • Established ability to work in a regulated environment, • Good presentation skills and scientific/technical writing skills, • Understanding of the concepts of cGxP, • Experience with mammalian cell culture, Human T-cell culture, • Experience writing laboratory SOPs and technical instructions, • 3-5 years of experience in pharmaceutical, biologics industry Additional Information Position is Full Time, Monday – Friday First Shift. Candidates currently living within a commutable distance of East Hanover, NJ are encouraged to apply. Excellent full-time benefits include: • Comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match, • Paid vacation and holiday, • Yearly goal-based bonus & eligibility for merit-based increases

Job Description We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall Responsibilities For Quality Operations And Initiatives, Including • Quality Assurance management:, • Documentation control (master batch record, specification and method), • Batch record review and product disposition, • Investigations, complaints, deviations, CAPAs, APRs, • Production and Pharmaceutical Development support, • APRs, GMP training and SOP review, • Validation / qualification documentation review and approval, • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site, • Develop, maintain, and enhance training programs and systems, • Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives., • Must be able to move about the facility, • Experience with FDA Audit, • Extensive knowledge of US and EU current Good Manufacturing Practices, • Experience with a CDMO would be preferable, • In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for: i). Quality Compliance management: ii). All audits, internal, external - regulatory, client and vendor iii). Vendor management program iv). QA Agreements with clients & contractors v). License renewals Company DescriptionWe are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..

Job DescriptionCompany Description Derex Technologies Inc specializes in providing IT consulting, staffing solutions and software services. Globally headquartered in Harrison New Jersey since 1996 Derex delivers the highest quality technology professionals and an array of customized IT talent solutions designed to improve productivity and drive results to global clients throughout North America. With over two decades of unparalleled experience, Derex provides supports to its clientele, across such industries as Systems Integration, Banking and Finance, Telecommunications, Pharmaceutical and Life Sciences, Energy, Healthcare, Technology, Transportation, and local and federal Government agencies. Job Description Position: Senior Software Engineer (Healthcare Interoperability) Location: Parsippany, NJ(On-Site) Full Time Job Overview The Senior Software Engineer will be responsible for the full development life cycle—from architecture and design, development, integration, and testing, to deployment, documentation, and support. The role emphasizes healthcare interoperability, FHIR integrations, and secure, scalable, microservices-based applications. This is a hands-on technical role involving both independent and team-based collaboration, requiring excellent communication skills, leadership qualities, and deep technical expertise. Responsibilities • Architect, design, and develop enterprise applications and microservices using Microsoft .NET/.NET Core, ASP.NET Core, C#., • Design and implement FHIR servers and RESTful APIs, ensuring compliance with HL7, SMART on FHIR, and interoperability standards., • Integrate FHIR services with EHR/EMR systems, HL7 v2/v3, and other healthcare data sources., • Implement authentication/authorization frameworks (OAuth2, OpenID Connect, SMART on FHIR) for secure data exchange., • Design and develop ETL processes and healthcare data import/export pipelines (JSON, XML, HL7, FHIR Bundles)., • Ensure applications conform to HIPAA, data security, and OWASP best practices., • Collaborate with Product Managers, Business Analysts, and clients to ensure timely delivery of business requirements and solutions., • Mentor and guide software engineers and support teams while coordinating with offshore/onshore teams., • Participate in Agile (Scrum) ceremonies, CI/CD, testing strategies, and DevOps pipelines., • Provide technical support for business applications post-deployment. Skills & Qualifications • 8+ years of software development experience in enterprise application design and development., • 2+ years of hands-on experience with healthcare interoperability standards (FHIR resources/bundles/search, HL7 v2/v3, SMART on FHIR)., • Strong proficiency in .NET, .NET Core, ASP.NET Core, C#, MVC, Web APIs, ADO.NET, Entity Framework, Dapper., • Experience with FHIR Servers/APIs (HAPI, Firely, Microsoft FHIR Server)., • Expertise in microservices, containerized application development (Docker, Kubernetes), and Azure DevOps/CI-CD pipelines., • Strong database experience with SQL Server performance tuning skills preferred., • Knowledge of SOLID design principles, object-oriented and functional programming., • Strong experience with source control systems (GitHub, TFS)., • Exposure to cloud platforms, particularly Microsoft Azure., • Strong problem-solving, analytical, and communication skills., • Ability to work independently in a fast-paced environment with changing priorities. Key Competencies • Communicates effectively– Attentively listens to others, provides timely and helpful information and is effective in a range of professional settings. Gives and receives feedback in a productive, professional manner. Demonstrates excellent oral and written communication skills., • Manages Ambiguity -Operating effectively, even when things are not certain, or the way forward is not clear. Is flexible in approach and can adapt their approach to meet changing business needs., • Manages complexity -Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems. Has strong organizational skills and can manage multiple activities at once. Has high attention to detail., • Ensures Accountability -Follows through on commitments and makes sure others do the same. Able to work independently as part of a small team. Regards, Manoj Derex Technologies INC Contact : 973-834-5005 Ext 206 Additional Information All your information will be kept confidential according to EEO guidelines.

Position: Analytical Lab Technician Location: Fair Lawn, NJ 07410 Duration: 6 Months Job Type: Temporary Assignment Work Type: Onsite Pay Rate: $30 to $35/hr Overview: TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands. Position Summary: The Process Engineer / Analytical Lab Technician will be responsible for developing and maintaining process control systems to ensure consistent product quality, with a focus on supporting the insourcing of materials and components. This role leads cross-functional efforts to qualify internal processes, validate materials, and transition manufacturing activities from external suppliers. The engineer ensures compliance with GMP, GDP, and regulatory standards while driving process improvements, supporting investigations, and managing documentation throughout the insourcing lifecycle. Key Responsibilities: • Develop, implement, and maintain process control systems to ensure consistent product quality and process efficiency, especially in areas impacted by insourced materials., • Analyze production and supply chain processes to identify bottlenecks, deviations, and improvement opportunities related to the insourcing of components or materials., • Collaborate with Quality Assurance, Product Development, Process Development, and Manufacturing teams to support the insourcing of materials by qualifying internal processes, materials, and suppliers., • Lead and support cross-functional initiatives to transition manufacturing processes or materials from external suppliers to internal operations., • Facilitate root cause analysis during quality investigations, particularly when introducing new internal processes or materials, and incorporate corrective and preventive actions., • Develop and review technical documentation (e.g., batch records, material specifications, validation protocols) to support the qualification and validation of insourced materials., • Coordinate with engineering and project teams to define inspection criteria, material acceptance standards, and validation procedures for internally sourced materials., • Manage documentation routing, review cycles, and project tracking to ensure timely completion of insourcing projects., • Prepare and route documentation for approval, ensuring adherence to Good Documentation Practices (GDP) and applicable regulatory requirements (e.g., FDA, GMP)., • Act as a liaison across internal teams (Manufacturing, Supply Chain, IT, Quality Control, etc.) to ensure seamless integration of insourced materials., • Occasionally interface with external suppliers and partners during the transition period to gather technical data or resolve quality issues., • Support execution of project plans related to material insourcing, ensuring actions, milestones, and deadlines are met., • Provide training for team members on new processes or materials introduced through insourcing efforts., • Ensure compliance with internal SOPs, GMP standards, GDP, and regulatory requirements during all phases of material insourcing and process control. Qualifications: • Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related technical field., • Experience with validation, process transfer, or insourcing/technology transfer is highly preferred., • Should have strong hands-on experience in preparing and analyzing samples and standards using basic laboratory equipment and instrumentation., • Experience with wet chemistry techniques and basic lab instrumentation (e.g., pH meter, balances, UV-Vis, titrations) is required., • Basic understanding of compendial methods (e.g., USP, EP, ACS)., • Strong understanding of GMP, GDP, and FDA quality system regulations., • Demonstrated ability to lead cross-functional projects and manage multiple priorities., • Excellent written and verbal communication skills., • Proficiency in technical writing and documentation control systems. TekWissen® Group is an equal opportunity employer supporting workforce diversity.

QC Manager – Fairfield, NJ Summary: The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. This position will manage the staff to schedule and perform all necessary testing to support manufacturing and release requirements. Responsible for training and personnel development. This is a hands- on position. In addition to managerial responsibilities, this position will be performing analytical testing including wet chemistry, GC, HPLC, etc. as needed Responsibilities: • Lead, coach and manage a team of analysts to ensure data integrity and performance to meet business objectives, • Train and develop analysts, • Formulate, document, and maintain quality control standards and on-going quality control objectives, • Schedule workload to meet release objectives and deadlines, • Review, interpret, analyze and report HPLC/GC/UV/FTIR data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines, • Author analytical methods and SOPs, • Clean, maintain, and troubleshoot HPLC/GC/UV/FTIR instruments, • Develop specifications and analytical methods as required, • Develop analytical methods to support product development projects, • Prepare analytical method validation protocols and reports, • Perform Laboratory Investigations, root cause analysis, CAPA, Change Controls, Validations, Stability Programs, APRs, statistical analysis, environmental monitoring of air, water, and surfaces, as needed., • Manage the outsourcing process of testing to contract laboratories, • Ensure lab safety and manage chemical inventory, • Improve the compliance of the laboratory operations as well improve the efficiency and reduce the cost of the operations, • Perform duties of QC Analyst as needed including HPLC sample preparation and testing and any other testing requirements, • Audit the work of QC Analysts, • Other duties assigned by Management Education: • Bachelor’s degree in a scientific discipline (Chemistry preferred) with a minimum of 5 years’ experience in laboratory management OR Master’s degree in a scientific discipline (Chemistry preferred) with a minimum of 3 years’ experience in laboratory management Experience Requirements: • Experience with Empower 3, • Experience working in an FDA regulated environment, • Experience with GC sample preparation and testing, • Knowledge of USP Monograph testing, analytical method development & validation, • Knowledge of CFR & ICH Regulatory Guidelines, • Knowledge of cGMP processes, lab safety and GDP. Computer Skills: • Proficiency in Microsoft Word, • Proficiency in Microsoft excel, • Proficiency in Empower 3 Other requirements: • Has significant technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory., • Able to perform complex mathematical problems, • In depth knowledge of all laboratory equipment, practices, and procedures, • Demonstrated managerial abilities, • Problem analysis, solving and resolution skills, • Has excellent oral and written skills, • Has excellent interpersonal skills, • Is self motivated, • Has a very high attention to detail, • Has a positive attitude, • Must speak, read, and write in English, • Able to lift 25 pounds, • Able to stand for extended periods Hours: • Standard: 8:30 AM to 5:00 PM, Monday through Friday, • Occasionally: Extended hours and/or Saturday and Sunday may be required as necessary to support manufacturing.

OVERVIEW: Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Clinical Lab Specialist. ** JOB ID: 52448 ** JOB TITLE: Clinical Lab Specialist ** LOCATION: Onsite Role 1 Becton Drive Franklin Lakes, NJ 07417 ** DURATION: 12 months + Pay Rate: $40.00/hr. - $44.00/hr. (depending upon experience) JOB RESPONSIBILITIES: • This laboratory-based position will provide input to design, evaluation, execution and reporting for safety and efficacy of new or modified in-vitro diagnostic devices, as well as provide innovative ideas cross functionally with other business units. Possess a technical competence and works with human blood in clinical laboratory disciplines such as phlebotomy, chemistry, hematology, coagulation, urinalysis, point of care and capable operation of numerous instrument platforms. Responsible for managing clinical laboratory studies and complaint testing through a variety of clinical testing methods. Knowledge and expertise demonstrating safety and efficacy of new or modified in-vitro diagnostic devices, as well provide innovative ideas outside of the core business. Develop/implement new testing methodologies in collaboration with R&D. Responsible for understanding product design, function and able to apply quality and regulatory standards. Capable of performing Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab. Utilizes technical/scientific judgment to resolve technical issues. Works with many different disciplines (manufacturing, marketing, quality, regulatory, etc.), materials, products and processes in the development of core clinical laboratory and outside the core clinical laboratory products and services. Possesses a strong commitment to quality and continuous improvement., • Provides input to and conducts scientific investigations in areas of considerable scope and complexity. Explores, identifies and recommends solution, concepts and principles., • Adapts methodologies as needed for areas related to the core clinical laboratory., • Conducts clinical testing, maintains laboratory instrumentation/reagent test systems and inventory to strategically align with the priorities within the lab and business objectives., • Implements and documents Quality Assurance and Quality Control procedures as they pertain to instrumentation and methodology., • Conducts instrument verification per CLSI guidelines, assists with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP., • Performs Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab., • Keeps current in the field of Clinical Laboratory Science through review of technical literature, participation in continuing education via webinars/symposia and or customer visits., • Trains new associates (permanent or temporary) on the Laboratory workflow., • Senses and monitors trends in laboratory practice and utilizes this information to recommend new projects and influence ongoing projects., • Participates in development of the clinical strategy for all client IDS- Specimen Management products and is responsible for generation of scientific and clinical information to support product conceptualization, feasibility and development., • Responsible for scientific integrity and clinical accuracy of all claims and communications made concerning specific PAS products globally., • Responsible for management of individual focused projects to complex projects involving multiple internal clinical studies/evaluations., • This position provides support from a base of clinical experience and knowledge to resolve customer complaints through clinical investigations., • This position will also provide support to guide and implement innovation, product development, clinical testing, manufacturing, and post market surveillance via interfacing with R&D and GCD to insure successful and timely completion of projects. JOB REQUIREMENTS: • Education: BA/MA in Clinical Laboratory Science or Medical Technology, Biology Life Sciences or health related field required., • MT/MLT CLS (ASCP) or equivalent experience in a Research environment, • 5 years+ experience in the Clinical Laboratory environment, • Strong working knowledge of clinical laboratory science, • Excellent verbal and written communications skills, • Awareness/basic knowledge of GCP/GLP and ISO regulations, • Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab, • Phlebotomy is a plus, • Experience with human blood specimen collection products, • Product Trouble shooting as it relates to clinical results, • Strong computer skills, • Strong project planning and budget management skills, • Develop/implement new testing methodologies in collaboration with R&D, • Proven understanding of clinical laboratory testing, blood collection, Urinalysis, POC and LIS/LIMS systems and an ability to apply knowledge to innovative concepts/projects beyond the core clinical laboratory I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you. Recruiter Name: Lalit Malgotra Title: Lead Recruiter Email ID: Company Overview: Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally: as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with a service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward. Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Applicants with criminal histories are considered in a manner that is consistent with local, state and federal laws.

The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. Formulate, document, and maintain quality control standards and on-going quality control objectives. Has significant technical knowledge of scientific principles, theories, and practices of

Job Description About CP Engineers With forty years of experience, CP Engineers delivers innovative solutions in site/civil, water/wastewater, municipal, MEP, and environmental engineering. Our project portfolio spans private, municipal, county, and regional clients, many of whom have partnered with us for decades. Remote work flexibility, competitive compensation and benefits, and a supportive culture have helped CP earn back-to-back Best Places to Work in NJ awards and driven strong employee retention. Due to expansion, we are seeking a Project Manager to join our MEP team. The salary range for this position is $110,000.00-$150,000.00, depending on experience. Key Responsibilities: • Lead and manage MEP engineering projects for industrial and manufacturing clients from concept through construction while building strong relationships., • Serve as the primary point of contact for clients, contractors, and internal teams ensuring effective communication and collaboration throughout the project., • Develop and maintain detailed project plans, budgets, and schedules to align with client expectations. Review deliverables ensuring the requirements of the project contract are being satisfied., • Coordinate multi-disciplinary engineering teams including mechanical, electrical, plumbing, structural, and fire protection., • Oversee and contribute to the preparation of engineering reports, design drawings, technical specifications, permit applications, and bid documents., • Provide Quality Control of prepared engineering documents., • Ensure all work complies with applicable codes, standards, and client requirements., • Conduct regular project status meetings with clients and team members., • Proactively identify and manage risks, delays, or design conflicts., • Oversee project staffing, scope changes, and contract compliance., • Ensure accurate invoicing and monitor receivables for projects., • Monitor project profitability and implement corrective actions, as necessary., • Foster relationships with new and existing clients to understand their needs and identify opportunities for additional work or services that can generate revenue., • Participate in business development activities by contributing to proposals, presentations, and relationship-building efforts with potential clients. Preferred Experience: • Industrial sectors such as pharmaceutical, food processing, automotive, warehousing/logistics, or advanced manufacturing., • Proven track record in commercial and industrial markets, managing large-scale mechanical/electrical systems and process utilities., • Experience acting as an owner’s representative, collaborating with clients and third parties on project delivery to ensure smooth execution from start to finish., • Ability to close deals and understand client needs, delivering tailored solutions., • Experience with vendor relations, contract negotiations, and overseeing project operations., • Track record of identifying new market opportunities and working closely with clients to align technical solutions with business goals and a focus on building strong relationships., • PMP Certification (helpful for project management)., • Bachelor’s degree in Engineering, Engineering Management, Project/Operations Management or related field preferred; significant experience in the MEP industry, particularly managing complex clients in the commercial and industrial sectors will be considered in lieu of preferred degree., • Minimum 5–8 years of relevant experience in engineering project management and/or owner’s representative experience overseeing MEP engineering projects. A background in project management methodologies and team leadership is essential for success in this role., • Proven experience managing projects in manufacturing and/or industrial facilities is strongly preferred., • Strong ability to engage with clients, understand their business needs, and identify opportunities for growth., • Strong understanding of building systems design, construction processes, and industrial facility requirements., • Proficient in project management software, including but not limited to project planning, task management, reporting and analytics to track progress and performance metrics., • Excellent leadership, communication, and organizational skills., • Flexible Work Options: Hybrid/remote work arrangement, • Work/Life Balance: Flexible hours, 20 days paid time off, • Financial Security: 401(k) with 4% company match, • Professional Growth: Tuition reimbursement, professional license and association fee coverage, • Comprehensive Health: Medical, dental, and vision insurance, • Supportive Culture: Commitment to employee well-being and career development

This position provides an exceptional opportunity to leverage your expertise in analytical chemistry to support the production and development of high-quality materials.

This position provides an exceptional opportunity to leverage your expertise in analytical chemistry to support the production and development of high-quality materials.

This position provides an exceptional opportunity to leverage your expertise in analytical chemistry to support the production and development of high-quality materials.

This position provides an exceptional opportunity to leverage your expertise in analytical chemistry to support the production and development of high-quality materials.

This position provides an exceptional opportunity to leverage your expertise in analytical chemistry to support the production and development of high-quality materials.