Senior Quality Systems Specialist

3 weeks ago


Raritan, New Jersey, United States J&J Family of Companies Full time

Job Summary:

We are seeking a highly skilled Senior Quality Systems Specialist to join our team at J&J Family of Companies. As a key member of our Quality Systems team, you will be responsible for independently performing Quality Systems activities, identifying issues, and implementing resolutions. You will assess data and prepare and review documentation to ensure compliance with our Quality Systems procedures and policies.

Key Responsibilities:

• Provide support and guidance for Quality Systems, including document management and metrics reporting.

• Ensure compliance to the Quality Systems procedures and policies.

• Actively participate in global super user network meetings and communicate relevant information to the team/site.

• Review a wide variety of documents for compliance to procedures, including SOPs, Work Instructions, Technical Documents, Logbooks, Forms.

• Drive alignment and efficiencies between global and local processes.

• Provide quality input on quality systems related issues and represent the department in meetings.

• Coordinate and conduct Quality Systems Review meetings.

• Support internal and external audits, inspections, pre-inspection readiness, certifications, tracking, and trending activities.

• Work closely with management and various team members to propose and complete improvements activities.

• Ability to respond swiftly to departmental and interdepartmental requests.

• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.

Requirements:

• Minimum of a Bachelor's degree in a relevant field, such as Biology, Engineering, Science, or equivalent technical subject area.

• A minimum of four (4) years of experience in Quality Systems, Quality Assurance, Quality Control, Validation, or Engineering in the pharmaceutical industry, across various roles.

• Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness, and adaptability.

• Ability to work on complex issues with minimal direction and think analytically.

What We Offer:

• Competitive salary range: $76,000-$121,900.

• Performance-based compensation programs.

• Comprehensive benefits package, including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Eligibility for the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• Time off benefits, including vacation, sick time, holiday pay, and personal and family time.

About Us:

J&J Family of Companies is an Affirmative Action and Equal Opportunity Employer. We are committed to creating a diverse and inclusive work environment that values the contributions of all employees. We believe in the importance of promoting a culture of respect, empathy, and understanding, and we strive to create a workplace where everyone feels valued, supported, and empowered to succeed.

How to Apply:

Interested candidates should submit their application through our website. We look forward to reviewing your qualifications and discussing this opportunity further with you.



  • Raritan, New Jersey, United States J&J Family of Companies Full time

    Job Title: Senior Specialist, Quality SystemsJob Summary:We are seeking a highly skilled Senior Specialist, Quality Systems to join our team at J&J Family of Companies. As a Senior Specialist, Quality Systems, you will be responsible for independently performing Quality Systems activities, identifying issues, and implementing resolutions. You will assess...


  • Raritan, New Jersey, United States J&J Family of Companies Full time

    Job Summary: We are seeking a highly skilled Senior Quality Systems Specialist to join our team at Janssen Pharmaceuticals, Inc., a member of the J&J Family of Companies. The successful candidate will be responsible for independently performing Quality Systems activities, identifying issues, and implementing resolutions.Key Responsibilities:Perform Quality...


  • Raritan, New Jersey, United States Johnson and Johnson Full time

    We are seeking a highly skilled Quality Systems Specialist to join our team at Johnson & Johnson. In this role, you will independently perform Quality Systems activities, identify issues, and implement resolutions, assess data, and independently prepare and review documentation.Key Responsibilities:Provide support and robust guidance for Quality Systems,...


  • Raritan, New Jersey, United States Johnson and Johnson Full time

    Johnson & Johnson is seeking a Senior Manager of Quality Management Systems to oversee the operations of the company's Technology Services QMS. This role will be responsible for ensuring the quality system is flawless, world-class, and adheres to GxP requirements and ISO regulations.The ideal candidate will have 8-10 years of progressive experience in the...


  • Raritan, New Jersey, United States Pioneer Data Systems Inc Full time

    Job Title: Packaging Quality Specialist IJob Description:The Packaging Quality Specialist I will support the Brand Protection Lab's operations by managing and inspecting product samples and ensuring the integrity of processes.This role requires strong attention to detail, adherence to procedures, and effective coordination with internal teams.The Packaging...


  • Raritan, New Jersey, United States Johnson and Johnson Full time

    Job SummaryJohnson & Johnson is seeking a Senior Manager of Quality Management Systems to oversee the operations of the company's Technology Services QMS. This role will be responsible for ensuring the highest standards of quality and compliance, and will work closely with the Director of the QMS to establish and maintain quality assurance standards.Key...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job Title: Master Data Governance Senior SpecialistJob Summary:Legend Biotech US is seeking a highly skilled Master Data Governance Senior Specialist to join our Technical Operations team based in Raritan, NJ. As a key member of our team, you will be responsible for designing and implementing a global standard data creation workflow process that supports our...


  • Raritan, New Jersey, United States Global Channel Management Full time

    About the role of Senior Laboratory Specialist at Global Channel Management:As a Senior Laboratory Specialist, you will be responsible for testing and validation of methods on Immunohematology products. You will ensure compliance with company standards and applicable regulatory agencies.Key responsibilities include:Performing testing and validation of...


  • Raritan, New Jersey, United States Sunrise Systems, Inc. Full time

    Job Title: Learning Technology SpecialistJob Summary:Sunrise Systems, Inc. is seeking a Learning Technology Specialist to support Learning inside the R&D organization. This role is located remotely.Key Responsibilities: Create and manage IM R&D platform-specific deliverables such as learning channels, journeys, pathways, smart cards, curricula, learning...


  • Raritan, New Jersey, United States Tekfortune Inc Full time

    At Tekfortune Inc, we are seeking a highly skilled Senior CSV Validation Specialist to join our team of experts in the pharmaceutical industry.The ideal candidate will have a strong background in system development lifecycle, computer system validation, and FDA regulations. They will be responsible for performing qualitative and quantitative analyses to...


  • Raritan, New Jersey, United States National Retail Systems Full time

    Job SummaryWe are seeking a skilled Transportation Specialist to join our team at National Retail Systems. As a key member of our logistics team, you will be responsible for delivering freight to dedicated accounts in a timely and safe manner.Key ResponsibilitiesDeliver freight to dedicated accounts on time and in good condition.Perform pre-trip and...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job SummaryWe are seeking a highly skilled Cell Therapy Quality Assurance Specialist to join our Quality team based in Raritan, NJ.The successful candidate will be responsible for performing quality control testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job DescriptionLegend Biotech US is a global biotechnology company dedicated to treating and curing life-threatening diseases. Our mission is to advance the promise of immunotherapy in the treatment of multiple myeloma.Job SummaryWe are seeking a highly skilled Quality Control Specialist to join our team based in Raritan, NJ. The successful candidate will be...


  • Raritan, New Jersey, United States SEBCO Full time

    Job OverviewAs a Senior Accounting Specialist/ Accounts Payable and Receivable, you will play a critical role in ensuring the smooth operation of our company's financial processes. Key ResponsibilitiesProcess and reconcile monthly invoices, ensuring accurate coding and entry into our accounting systems.Collaborate with our offshore bookkeeping team to...

  • IT Support Specialist

    1 month ago


    Raritan, New Jersey, United States TEKsystems Full time

    Job DescriptionTEKsystems is seeking a skilled IT Support Specialist to join our team. As a Helpdesk Technician, you will be responsible for providing technical support to clients, troubleshooting hardware and software issues, and escalating complex problems to senior technicians.Key Responsibilities:Provide technical support to clients via phone, email, and...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job SummaryLegend Biotech US is seeking a highly skilled Quality Control Specialist to join our team in Raritan, NJ. As a key member of our Quality team, you will be responsible for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job Title: QA Document Control LeadLegend Biotech US is seeking a highly skilled QA Document Control Lead to join our Quality team based in Rarita, NJ.Job Summary:The QA Document Control Lead will be responsible for supporting the document management process within a cell therapy manufacturing facility to meet both clinical and commercial requirements in a...


  • Raritan, New Jersey, United States Ortho Clinical Diagnostics Full time

    The OpportunityQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are a global organization with over 6,000 employees, operating in more than 130...


  • Raritan, New Jersey, United States Pyramid Consulting, Inc Full time

    Job Summary: We are seeking a highly skilled Administrative Support Specialist to join our team at Pyramid Consulting, Inc. as a contract position. The ideal candidate will have a minimum of 6-10 years of experience in an administrative capacity supporting senior management.Key Responsibilities:Provide proactive calendar coordination, including scheduling...

  • AI Systems Architect

    1 month ago


    Raritan, New Jersey, United States Snapx Full time

    We are seeking a highly skilled Gen AI Architect to join our team at Snapx. The ideal candidate will have a strong background in computer science, artificial intelligence, and machine learning, with a proven track record of developing and implementing innovative Gen AI solutions.Key Responsibilities:Design and develop advanced Gen AI models using techniques...