Full-Time

QC Technician

Confirmed live in the last 24 hours

CAI

CAI

1-10 employees

Consulting for operational readiness in healthcare

Compensation Overview

€35k - €80k/yr

Mid, Senior

Limerick, Ireland

The position is onsite in Limerick, Ireland.

Category
Lab & Research
Interdisciplinary Research
Life Sciences
Requirements
  • BS or MS in a relevant science or engineering field, or equivalent experience.
  • 3+ years of industry related experience
  • Strong oral and written communication skills, with a focus on clear documentation and reporting.
  • Excellent problem-solving skills with a Quality Control mindset.
  • Strong customer-service orientation.
  • Proficient in life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or with equivalent experience.
  • Willing and able to travel domestically and internationally, if required.
Responsibilities
  • Support Quality Control by ensuring compliance with data integrity (DI) and IT standards throughout all documentation and equipment qualification activities.
  • Assist in the preparation, review, and management of technical documents related to IT systems and data integration, focusing on accuracy, clarity, and adherence to regulatory standards.
  • Develop and maintain clear procedures for data handling, system validation, and IT processes to ensure robust quality and DI practices are embedded within workflows.
  • Review and verify Test Outlines and Procedures (TOPs) for IT systems, ensuring alignment with quality and DI specifications.
  • Help coordinate IT system qualification activities, including data verification and validation tasks, while adhering to timelines and quality benchmarks.
  • Prepare and maintain Qualification Summary Reports (QSRs) and other documentation to track compliance with quality and DI standards.
  • Conduct reviews of system Design Evaluations, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to verify quality outcomes for IT systems.
  • Manage QC processes related to IT qualifications, including document control, change controls, and oversight of DI compliance.
  • Collaborate with IT project teams, contractors, and vendors to execute and validate testing, ensuring strict adherence to data integrity and quality control.
  • Allocate resources and support the organization of documentation and materials needed to meet QC and IT deliverables.
  • Provide quality assurance support throughout IT system qualification, ensuring that all documentation meets regulatory and DI requirements.

CAI Technical Consulting Malaysia SDN, under the brand cagents.com, offers consulting services focused on operational readiness for clients in the pharmaceutical, biotechnology, and healthcare sectors. They conduct operational readiness assessments to evaluate a company's preparedness and tailor their services accordingly, which include project planning and asset management. CAI stands out from competitors by emphasizing professional development and industry collaboration, ensuring their team stays updated on industry trends. Their goal is to help clients achieve operational excellence and readiness for full-scale production.

Company Size

1-10

Company Stage

Pre-seed

Total Funding

$3.4M

Headquarters

Overland Park, Kansas

Founded

1996

Simplify Jobs

Simplify's Take

What believers are saying

  • Demand for digital transformation in life sciences boosts CAI's automation consulting services.
  • Personalized medicine trends create opportunities for flexible manufacturing process consulting.
  • Data centers' focus on energy efficiency aligns with CAI's energy management expertise.

What critics are saying

  • Competition from specialized firms in digital transformation may erode CAI's market share.
  • In-house consulting teams in corporations could reduce demand for CAI's services.
  • Remote work models decrease demand for traditional on-site consulting, impacting CAI's operations.

What makes CAI unique

  • CAI offers comprehensive consulting services across multiple industries, including life sciences.
  • Their expertise in energy management aligns with the sustainability focus of data centers.
  • CAI's risk management services cater to the growing cybersecurity needs in process manufacturing.

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Benefits

100% Employee Owned

24 Days PTO/5 Sick days per year + Additional Holidays depending on Country

Medical / Dental / Vision (In accordance with each countries’ applicable regulations)

Professional Development (Approximately $5,000 paid career-related, continuing education)

ESOP/401k – 15% Company Contribution

Company Paid Long-Term Disability

Company Paid Life Insurance

Company Paid Parental Leave (In accordance with each countries’ applicable regulations)

Other Benefits Depending on Country