Xyntek Inc

QC Systems Administrator - Empower

Xyntek Inc  •  Cork, IE (Onsite)  •  3 hours ago
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Job Description

Catalyx is seeking a QC Systems Admin to join our team and work on our customer site in Cork.

Who We Are:

Catalyx is a machine vision and automation company that integrates technology and people to help global manufacturers and logistics companies achieve next-generation levels of quality and throughput. For over thirty years, the minds behind Catalyx have been at work maximizing operational processes across highly regulated industries by inventing new technology applications and supporting companies with technical experts. With 9 global offices, over 550 team members, and 3,000 projects under our belt (and counting), we have the capabilities and reach to solve unique process problems at scale – and the vision to keep doing what’s never been done before. For more information visit www.catalyx.ai

The Role:

The role will act as a key point of contact for Empower, providing day-to-day system support, resolving issues and supporting wider site and global systems projects.

The successful candidate will work closely with QC teams and other stakeholders to support the effective use of Empower while maintaining compliance with applicable quality and regulatory requirements.

Responsibilities:

  • Provide day-to-day Empower support and manage the resolution of system support tickets.

  • Build and maintain Empower Master Projects, including customised fields and methods.

  • Perform system review activities.

  • Participate in site and global systems projects.

  • Act as an Empower SME during GxP inspections, where required.

  • Support the review and approval of quality investigations, CAPAs and change controls.

  • Support laboratory investigations using appropriate problem-solving methodologies.

  • Provide Empower training, mentoring and guidance to users as required.

  • Work collaboratively with QC and cross-functional teams to resolve issues and support continuous improvement.

  • Maintain compliance with company policies, procedures and applicable quality requirements.

Requirements:

  • BSc in Science, Engineering, a technical discipline or similar.

  • 3+ years’ experience working with Empower as an administrator, SME or key user.

  • Experience supporting and troubleshooting Empower within a regulated environment.

  • Knowledge of FDA and EMEA regulatory requirements.

  • Experience supporting regulatory, customer or internal audits as an SME.

  • Experience with investigations, CAPAs and change control.

  • Good problem-solving and analytical skills.

  • Ability to work independently and manage priorities to meet deadlines.

  • Good communication and stakeholder management skills.

  • Continuous improvement mindset and ability to work effectively across different teams.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.

Xyntek Inc

About Xyntek Inc

As part of CXV Global, we offer a powerful platform of combined technologies and professional services that optimise life sciences’ and high-end operations across product development, manufacturing, packaging and distribution. Key features include:

-A comprehensive portfolio of innovative automation solutions and digitization capabilities encompassing machine vision, serialization, digitization, and resourcing for R&D and manufacturing sites

-An extensive global network anchored by a strong presence in two of the world’s largest life sciences markets: Europe and the U.S.

-24×7 production activity and multi-site, multi-national and multi-lingual project support spanning 10 time zones

-High-touch service from a global workforce of 500+ employees possessing deep technical and engineering expertise

For more information visit www.cxvglobal.com

Industry
Manufacturing & Production
Company Size
11-50 employees
Headquarters
Newtown, PA
Year Founded
Unknown
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