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GxP Systems Support

ProStaff Solutions

  • New Brunswick, New Jersey
  • 8 days ago

    Highlights

    Assist with QMS processes and documentation related to change control, impact assessments, CAPA execution and managing deviations and incidents through root cause analysis for GxP systems changes. The role will support critical business functions by ensuring GxP systems remain compliant with regulatory requirements while providing technical support, system administration, and quality documentation assistance.

    Numbers & Facts

    LocationNew Brunswick, New Jersey
    IndustryStaffing/Employment Agencies
    Company Size100 to 499 employees
    Websitehttp://prostaffnj.com/

    Description

    Our client, a leading pharmaceutical manufacturing company, is seeking an experienced GxP Systems Support professional to join its team in New Brunswick, NJ. This onsite contract opportunity is ideal for candidates with experience supporting GxP-regulated systems and applications within a pharmaceutical or life sciences environment. The role will support critical business functions by ensuring GxP systems remain compliant with regulatory requirements while providing technical support, system administration, and quality documentation assistance. Candidates with a strong understanding of computer system validation, quality management systems, and FDA regulations are encouraged to apply.

    On-site
    Contract
    Pay rate: DoE

    Primary Responsibilities:
    • Collaborate with team members and business partners in various GxP functions such as Quality Control Lab, Manufacturing, Packaging etc. to:
    • Provide support on a variety of GxP applications including, but not limited to, user access management, periodic reviews and other assigned activities in line with the regulatory agency expectations and organization’s SOPs,
    • Perform GxP assessments as mandated by the Quality unit or Regulatory Agencies.
    • Resolve reported issues in a compliant and a timely manner.
    • Ensure that all support and administration activities are executed in alignment with regulatory expectations, 21 CFR Part 11requirements and the organization’s SOPs.
    • Assist with QMS processes and documentation related to change control, impact assessments, CAPA execution and managing deviations and incidents through root cause analysis for GxP systems changes.
    • Propose alternate processes, procedures and process automation pathways to streamline and increase effectiveness and efficiency of IT operations in GxP areas.
    • Support regulatory, customer and other such audits from IT department.
     
    Qualifications and Experience:
    • Minimum of a Bachelor's Degree. Preference will be given to a candidate having a bachelor’s degree in Life Sciences, Pharmacy, Computer Science or Computer Information Systems (CIS) or related field. 
    • Minimum of 5 years of experience in a similar environment.
    • Proven ability to support instrumentation applications such as Trackwise, OpenText D2, LMS, Empower3, LabX, FTIR, UV/Vis or similar.
    • Excellent understanding of GAMP 5, 21 CFR Part11, Computer System Validation and Quality Management System.
    • Ability to multi-task, manage competing priorities and flexibility to shift workload when needed.
    • Excellent written and verbal communication skills and working knowledge of Microsoft Office Applications.
    • A team player with ability to work with people at all levels and diverse skill sets.
     
    Other Considerations:
    • May require travel to other manufacturing sites (Princeton, NJ / NY / MA) as required.

    About ProStaff Workforce Solutions
    We are a fast growing and successful agency that treats all its clients and candidates with a personal touch. ProStaff Workforce Solutions is a group of industry experts—many hailing from larger agencies—who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail. Our mission is to match quality people with quality jobs and quality companies to maximize productivity and profitability. We develop long-term relationships and provide a level of customer service and expertise that instill confidence and trust in our client companies and candidates.

    Our Values
    • Integrity
    • Commitment
    • Quality
    • Diversity

    Benefits for eligible employees
    • Direct deposit
    • Weekly pay
    • Medical benefits
    • 401(k) Plan

    Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.


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    About Company

    ProStaff is unlike other staffing or recruiting agencies.

    We are a fast growing and successful agency that treats all its clients with a personal touch. Headquartered in South Amboy, ProStaff Solutions is a small group of industry experts—many hailing from larger agencies—who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail.We all pick up the phones, so it’s not unusual to get our executives on the line when you call. We want to be accessible and accountable to you.

    What makes us unique?
    Customer service and responsiveness are required of everyone who works at ProStaff. Our mission is to bring the right people to the right job every time. This is not easy, but it can be done.

    To accomplish this, we make the effort to learn about your needs and use a careful screening process before we do any introductions. We value your time. If we bring you the wrong candidates or send you to the wrong companies, we’re not doing our job.

    ProStaff can handle rush orders with skill, but we always understand our clients before proceeding. That’s why many people are loyal to us. We have worked with blue chip names such as Bed, Bath and Beyond and US Foods, as well as internet-based newcomers such as Blue Apron and Burlington Coat Factory.

    Underlying ProStaff’s success are these values:

    • Hard work
    • Integrity
    • Honesty
    • Helping the communities we serve

     

    When we uphold our values, ProStaff Solutions Maintains Its good name–which is of utmost importance to us. It’s the heart of our business.

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