Quality Technician

About Cambrex

Cambrex is a prominent global contract development and manufacturing organization (CDMO) providing drug substance development and production solutions throughout the complete drug lifecycle. The company delivers extensive analytical and IND enabling services with over four decades of expertise. Employing about 2,000 professionals, Cambrex supports clients primarily in North America and Europe. Their specialized capabilities include continuous flow processes, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and handling highly potent APIs.

At Cambrex, employees are encouraged to engage in work that directly impacts customers and patients. The company fosters a supportive environment for learning new skills while promoting a culture of safety and collegiality. Cambrex values building connections among its workforce and the surrounding community. They provide comprehensive benefits covering health care, life insurance, and retirement planning.

Role Overview

We are currently recruiting for the role of Quality Technician, reporting to the Quality Manager in Waterford, Ireland. This crucial position supports the growth of our Quality department by ensuring adherence to established quality standards and regulatory compliance.

Key Responsibilities

• Assist and advise the organization on Quality Management System (QMS) activities ensuring compliance with company policies and cGMP standards.
• Continuously monitor and recommend improvements and corrective/preventative actions within the QMS.
• Investigate and accurately document any deviations, whether planned or unplanned.
• Review completed documentation to verify compliance with specifications and completeness of records.
• Propose and review document changes as needed, maintain both electronic and physical indexes.
• Manage the issuance of document numbers and controlled documents such as logbooks and protocol executions.
• Provide administrative support for all electronic QMS activities.
• Collaborate effectively with other team members.
• Conduct internal audits and reviews to ensure ongoing compliance with GMP certifications.
• Coordinate preparation and documentation for all internal, regulatory, customer, and supplier audits.

Qualifications and Skills

• Degree in a science-related field is preferable.
• Prior experience (1-2 years) in a quality or administrative role, preferably within a regulated environment.
• Excellent attention to detail and organizational capabilities.

Working Hours and Conditions

• This is a permanent full-time position with work hours from 8:30 am to 5:00 pm, Monday through Friday.
• Employment offers are conditional upon successful completion of a comprehensive pre-employment screening, including drug testing, criminal background checks, identity verification, reference, education, and employment validation.
• The company is dedicated to providing accommodations for qualified individuals with disabilities.
• Cambrex is an Equal Opportunity/Affirmative Action employer and considers all applicants without discrimination.