Quality Technician - Military veterans preferred

Cambrex


Quality Technician

IE--Waterford

Job ID: 2025-4379
Type: Regular Full-Time
# of Openings: 1
Category: Quality Assurance
Cambrex - Waterford

Overview

The Quality Lead is responsible for verifying that quality is being maintained throughout the stability storage and sample management process.

Specific responsibilities include but are not limited to:

QMS:

• Provision of assistance and advice to the Company on all QMS activities.
• Ensure that all Q1 activities meet the quality standards specified by the Company QMS and in accordance with cGMP standards.
• Continually monitors the QMS system suggesting improvements and CAPA measures.
• Administration of quality manuals, continuous improvement initiatives & interaction with management personnel on quality initiatives.
• Ensure all planned and unplanned changes (deviations) are adequately investigated and documented.

Audits:

• Ensure compliance to GMP certification by conducting and reporting internal reviews.
• Co-ordinates, prepares and is the lead for all internal, regulatory, supplier and customer audits.

Operational Activities:

Administration of quality documents, continuous improvement initiatives and interaction with management personnel on quality issues to include but not limited to:

• Providing admin assistance to the Company on all QMS activities issuing controlled documents (logbooks, protocols for execution, etc.).
• Maintenance of indexes 
• Issue of document numbers.
• Review of completed documents for compliance to specification and to ensure all entries are complete.
• Proposing/reviewing document changes as appropriate.
• Performing daily checks on stability cabinets/room conditions as appropriate (in the absence of Operations).
• Providing support as required for checking of samples on receipt at Q1 Scientific/on return to Client as appropriate.
• Reviewing calibration and temperature mapping activities

• Primary degree preferable but not essential
• Experience in working in a regulated environment
• 2-3 years experience in QA 

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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