Quality Technician

About Cambrex

Cambrex is a global contract development and manufacturing organization (CDMO) focused on drug substance development and manufacturing throughout the full drug lifecycle, along with analytical and IND-enabling services. The company has more than 40 years of experience and a team of around 2,000 specialists serving clients across North America and Europe. Its technical capabilities include continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Role Overview

Cambrex is looking for a Quality Technician to join its Waterford team. This position reports to the Quality Manager in Waterford and plays an important part in the continued growth of the Quality department.

Key Responsibilities

The role supports quality management system activities, document control, and audit readiness across the site. It involves helping the business maintain compliance with company quality standards and cGMP expectations, while also assisting with electronic quality system tasks and cross-functional coordination.

• Support the company on all quality management system activities and provide guidance where needed.
• Help ensure Q1-related activities align with the company QMS and cGMP requirements.
• Monitor the QMS continuously and suggest improvements, including corrective and preventive actions.
• Investigate and document planned and unplanned changes or deviations thoroughly.
• Check completed records to confirm they meet specifications and are fully and accurately completed.
• Draft and review document updates when required.
• Maintain both electronic and paper-based indexes.
• Assign document numbers and manage controlled documents such as logbooks and execution protocols.
• Support the administration of eQMS activities.
• Work closely with other team members to keep quality processes running smoothly.
• Carry out internal reviews to support GMP certification compliance and prepare reports from those reviews.
• Coordinate and prepare for internal, regulatory, supplier, and customer audits.

Skills and Experience

• Very strong attention to detail.
• Good organisation and time management.
• Ability to work accurately with controlled documents and compliance records.
• Familiarity with quality systems in a regulated environment is beneficial.
• Comfort working with administrative tasks in a quality setting.

Education and Experience Requirements

• A degree in a science-related subject is preferred.
• Previous experience in a regulated environment is an advantage.
• About 1 to 2 years of experience in a quality or administrative role is preferred.
• Strong attention to detail and organisational ability are essential.

Working Hours

This is a full-time, permanent role. Standard hours are 8:30am to 5:00pm, Monday to Friday.

Pre-Employment Conditions

Any offer of employment depends on successful completion of a pre-employment screening process. This may include, depending on applicable laws, a drug test, criminal record check, identity verification, reference checks, and verification of education and work history. Refusal to complete testing will remove the candidate from further consideration.

Equal Opportunity

Cambrex states that all requirements may be reasonably adjusted to accommodate individuals with disabilities. The company is an equal opportunity and affirmative action employer and considers qualified applicants without regard to protected characteristics including race, colour, religion, sex, pregnancy, sexual orientation, gender identity, ancestry, national origin, place of birth, age, marital status, disability, genetic information, veteran status, or other legally protected status.

Benefits

The company offers a competitive benefits package, including healthcare, life insurance, retirement planning, and additional benefits.