Aseptic Manufacturing Expert

3 days ago


Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Aseptic Manufacturing Expert: We are seeking an experienced Aseptic Manufacturing Expert to join our team in Allendale, NJ. In this role, you will be responsible for ensuring the safe and efficient manufacturing of cellular products. Your tasks will include reviewing and approving batch records, SOPs, qualification and validation reports; managing internal and external audits; and developing and implementing quality systems and procedures. You will also work closely with cross-functional teams to ensure effective implementation of quality systems and procedures.

This role involves exercising judgment within generally defined practices and policies when selecting methods and techniques for obtaining solutions. You will also have the opportunity to work independently and as part of a team to achieve goals and objectives. Other responsibilities include prioritizing, scheduling, and managing multiple projects and resources; ensuring the safe release of cellular products according to company and/or client procedures and requirements; promoting compliance with applicable CGMP and GTP regulations and company SOPs; and providing input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.

Requirements:
  • BS in biological sciences or other relevant field of study
  • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics.
  • Working knowledge and technical understanding of aseptic manufacture of biologics
  • Understanding of quality system applications
  • Experience in both clinical and commercial manufacturing is preferred.
  • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc.
  • Computer skills (Microsoft Office, Outlook)

Salary: $90,000 - $120,000 per year

  • Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job OverviewWe are seeking an experienced Manufacturing Process Associate to join our production team at Lynkx Staffing LLC in Allendale, NJ. In this role, you will be responsible for processing and manipulating cell products, ensuring quality and safety standards are met.Key ResponsibilitiesProcess and manipulate cell products according to established...

  • Operations Manager

    4 weeks ago


    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job OverviewLynkx Staffing LLC is a leading staffing agency specializing in the Biotechnology, Pharmaceutical, and Medical Devices industries in New Jersey. As an Associate Director of Manufacturing Operations, you will play a crucial role in optimizing operations resources to meet customer demand.ResponsibilitiesDevelop and implement strategies for...


  • Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    About the JobWe are seeking a skilled Biotechnology Production Specialist to join our team at Lynkx Staffing LLC in Allendale, NJ. As a key member of our production team, you will be responsible for processing and manipulating cell products using aseptic techniques, following written Standard Operating procedures.Key ResponsibilitiesPerform aseptic...


  • Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    OverviewLynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical, and Medical Devices industries in New Jersey. We are committed to delivering exceptional service to our clients while providing our candidates with unparalleled opportunities. As a Quality Assurance Compliance Specialist, you will play a vital role...


  • Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job Title: Quality Assurance AssociateThe Lynkx Staffing LLC team is seeking a skilled Quality Assurance Associate to join their dynamic organization in Allendale, NJ. As a key member of the quality assurance team, you will be responsible for performing quality assurance activities with minimal supervision. Your tasks will include document management,...


  • Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Lynkx Staffing LLC is seeking an experienced Quality Assurance Associate III to join our team. As a member of our quality assurance department, you will play a critical role in ensuring the quality of our products and services. This position requires a strong understanding of quality systems and procedures, as well as excellent communication and...


  • Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Cell Processing Technician II Job DescriptionWe are seeking a highly skilled Cell Processing Technician II to join our production team at Lynkx Staffing LLC in Allendale, NJ. In this role, you will be responsible for processing and manipulating cell products, ensuring quality and safety standards are met.Key ResponsibilitiesProcess and manipulate cell...


  • Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    About the PositionThis Manufacturing Regulatory Expert role at Lynkx Staffing LLC offers a challenging opportunity to work in the Pharmaceutical industry. As part of our team, you will be responsible for ensuring compliance with regulatory requirements, including Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory...


  • Oak Brook, Illinois, United States Novipax Buyer LLC Full time

    Job SummaryThe Manufacturing/Project Engineer is a key member of the engineering team at Novipax. This role is responsible for the execution of complex projects from cradle-to-grave, ensuring alignment with the company's strategic objectives.You will work closely with operations and technical experts to solve internal customers' most challenging projects....


  • Oak Brook, Illinois, United States TreeHouse Foods Full time

    Company OverviewTreeHouse Foods is a leading manufacturer of private label packaged foods and beverages. With a network of production facilities and corporate offices across the United States and Canada, we are committed to excellence in our products and people.About the RoleThis Manufacturing and MII Architect position requires a technical expert who can...


  • Oak Brook, Illinois, United States Blistex Inc Full time

    About the Role:We are looking for an experienced Formulation Development Expert to join our Blistex Inc R&D team. This role involves formulating and scaling up various formulation types, requiring a strong understanding of the physical, chemical, biological, microbiological, engineering, and regulatory aspects of the development and technology transfer...


  • Oak Brook, United States Novipax Buyer LLC Full time

    Headquartered in Oak Brook, Illinois, with plants strategically located across the USA, Novipax is safeguarding the future by partnering with fresh protein and produce processors, grocery retailers, foodservice providers, packaging distributors, and healthcare providers to deliver absorbent solutions that protect packaged fresh food and healthcare...


  • Pine Brook, United States Kearfott Corporation Full time

    Company OverviewKearfott Corporation is a global leader in the design and manufacture of precision motion control products and inertial navigation components. With over 100 years of expertise, Kearfott is dedicated to providing quality, reliability, and cutting-edge technology to customers worldwide.

  • Peloton Expert

    2 weeks ago


    Oak Brook, United States Disability Solutions Full time

    ABOUT THE ROLEAs a Peloton Expert, you are passionate about fitness, technology, and all things Peloton. Reporting to a Store Manager, you provide excellent in-store experiences and sales support within our retail stores. You educate visitors on the portfolio of Peloton products and content, creating meaningful interactions, customized solutions, and closing...


  • Brook Park, Minnesota, United States Ambient Enterprises Full time

    Job SummaryAmbient Enterprises seeks a skilled Senior VFD Technician to join our team. As a key member of our technical services group, you will be responsible for the installation, troubleshooting, and commissioning of VFD units out in the field. With a strong focus on safety procedures and minimal callbacks, you will ensure precise and efficient operation...


  • Oak Brook, Illinois, United States Winland Foods Full time

    Company Overview:">Winland Foods is a leading private label food manufacturer with nearly 3,000 employees operating out of 14 production facilities in the US, Canada, and Italy.We are creating an innovative and agile organization that delivers high-quality food to our customers and communities.">Salary: $67,000 - $72,000 per year, depending on experience and...


  • Oak Brook, Illinois, United States Cullerton Group Full time

    About Cullerton GroupCullerton Group is a renowned company seeking an experienced SAP Warehouse and Distribution Specialist to join our team. This role requires 50% travel and offers a competitive compensation package, including $160K/yr + 20% bonus ($192K/yr total compensation).Job Description:We are looking for a skilled SAP professional to design,...


  • Oak Brook, United States Barry-Wehmiller Companies Inc Full time

    About Us: BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine...


  • Oak Brook, Illinois, United States Winland Foods Full time

    Job Overview:We are looking for a highly skilled Product Development Specialist to join our Research, Development & Innovation team at Winland Foods.This role involves applying packaging science principles to meet project objectives, working closely with experienced professionals, and gaining hands-on experience in finance, project management, and...


  • Oak Brook, United States Winland Foods Full time

    Winland Foods, Inc., based in Oak Brook, IL, is a global manufacturer of private label and branded foods for retail and co-pack customers. We use only the finest ingredients and ensure every product we make meets the highest standards of taste, quality and accessibility. Across all our food categories, we offer customers a range of premium and value...


  • Oak Brook, United States TreeHouse Foods Full time

    Employee Type:Full timeLocation:IL Oak BrookJob Type:Information TechnologyJob Posting Title:MFG and MII Architect, Business Systems Analyst About Us : TreeHouse Foods (NYSE: THS) is a leading manufacturer of private label packaged foods and beverages, operating a network of more than two dozen production facilities and several corporate offices across the...

  • SAP MII Architect

    5 months ago


    Oak Brook, United States TreeHouse Foods Full time

    About Us: TreeHouse Foods (NYSE: THS) is a leading manufacturer of private label packaged foods and beverages, operating a network of more than two dozen production facilities and several corporate offices across the United States and Canada. At TreeHouse Foods, our commitment to excellence extends beyond our products and revolves around our people. We are...

  • SAP MFG Architect

    11 hours ago


    Oak Brook, United States TreeHouse Foods Full time

    About Us: TreeHouse Foods (NYSE: THS) is a leading manufacturer of private label packaged foods and beverages, operating a network of more than two dozen production facilities and several corporate offices across the United States and Canada. At TreeHouse Foods, our commitment to excellence extends beyond our products and revolves around our people. We are...


  • Oak Brook, United States Winland Foods, Inc. Full time

    Winland Foods, Inc., based in Oak Brook, IL, is a global manufacturer of private label and branded foods for retail and co-pack customers. We use only the finest ingredients and ensure every product we make meets the highest standards of taste, quality and accessibility. Across all our food categories, we offer customers a range of premium and value...

  • OT Solutions Architect

    2 months ago


    Oak Brook, United States The LaSalle Group Full time

    Our client is at the forefront of food manufacturing, specializing in innovative technology solutions that drive efficiency and excellence. They are embarking on an exciting journey to develop a cutting-edge greenfield Operational Technology (OT) program and are seeking a visionary OT Solutions Architect to lead this transformative initiative. As an OT...