Technical Support

3 weeks ago

Dublin, Dublin City, Ireland Charles River Full time

For 75 years, Charles River employees have collaborated to aid in the discovery, development, and safe production of new drug treatments. When you join our team, you'll make a significant impact on global well-being. It doesn't matter if your expertise lies in life sciences, finance, IT, sales or any other field – your skills will be crucial to our work. In return, we'll help you build a career that truly inspires you.

ROLE REQUIREMENTS:

  • Assist customers with testing support and address queries and issues related to our product lines (Celsis and Endosafe).
  • Aid in product returns and complaints, ensuring accurate documentation as per SOP and site-specific GDP requirements.
  • Collaborate with quality assurance teams in Dublin and Charleston-USA to investigate and resolve customer complaints effectively.
  • Conduct IQ, OQ, PQ of lab equipment like Advance II, Biotek, Cartridge readers (MCS, PTS) and maintain necessary documentation.
  • Provide training to internal colleagues and ensure proper documentation of all training sessions in line with site-specific SOPs.
  • Handle contract testing for Celsis and LAL, including method development and validation studies, accessory releases, CSE/RSE, LAL water, among others.
  • Engage in laboratory tasks essential for isolating, cultivating, and preserving bacterial cultures.
  • Ensure compliance with relevant regulatory standards (cGMP, FDA, ISO), departmental procedures, and safety regulations [SOPs, biosafety protocols].
  • Review and update SOPs, protocols, and other controlled documents for Technical Service, aligning them with GMP regulations and internal policies.
  • Participate in inspections and audits as necessary.
  • Generate sample testing reports and peer review reports following SOPs and Protocols.
  • Compile and present process metrics associated with Technical Service for management review, analyzing data to identify trends or potential issues and recommending corrective measures.
  • Utilize effective data review and analysis processes (Statistical review, Minitab, PowerBI, etc.) with necessary training provided.
  • Perform any other relevant duties as assigned.

QUALIFICATIONS:

  • Education: Bachelor's Degree (B.A. /B.S.) in Microbiology / Biology or a related field.
  • Experience: 1-2 years experience as a Microbiologist. 2 years experience in quality systems, data review, metrics collection and reporting in a GMP/GLP environment; or an equivalent combination of education and experience.
  • Other: Advanced computer skills required, especially in Microsoft Excel. Attention to detail and organizational abilities are a must.

Note: To be considered for this role, a resume is mandatory. If you haven't uploaded yours yet, please do so in your candidate profile.

About Microbial Solutions
Our Microbial Solutions division offers a wide range of endotoxin testing, microbial detection, and identification products and services tailored to the industry's evolving needs. We assist clients in ensuring product safety and quality through user-friendly, reliable testing solutions that meet regulatory standards, aiding crucial decision-making and enhancing operational efficiency.

About Charles River
Charles River is a leading contract research organization (CRO) specializing in early-stage services. We leverage our expertise in laboratory animal science to provide diverse discovery and safety assessment services, both GLP and non-GLP, supporting clients from target identification through preclinical stages. Additionally, we offer products and services to facilitate clients' clinical laboratory testing and manufacturing operations. This comprehensive portfolio helps clients adopt a more adaptable drug development model, cutting costs, and accelerating time-to-market.

With a global workforce of over 20,000 employees across 110 facilities in 20 countries, we can effectively harness worldwide resources and diverse perspectives to address our clients' unique challenges. Our client base includes global pharmaceutical and biotechnology firms, government entities, hospitals, as well as academic institutions worldwide.

At Charles River, we are dedicated to enhancing people's quality of life. Our mission, scientific excellence, and unwavering sense of purpose drive us every day, knowing that our efforts contribute to global health and well-being. We are proud to have supported the development of 86% of FDA-approved drugs in 2021.

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