Overview
Quality Assurance Specialist Jobs in Waterford Metropolitan Area at EFOR
Title: Quality Assurance Specialist
Company: EFOR
Location: Waterford Metropolitan Area
Job Purpose: The QA Specialist is responsible for ensuring compliance with quality standards and regulatory requirements within the organization. The specialist will focus on inspection readiness, perform investigations into non-conformances, and drive corrective and preventive action (CAPA) processes to maintain and improve product quality.
Key Responsibilities:
Quality Assurance:
- Oversee and monitor adherence to internal quality standards, SOPs, and regulatory requirements.
- Participate in development and revision of quality documentation and procedures.
Inspection Readiness:
- Ensure that all areas and records are consistently prepared for regulatory and client inspections/audits.
- Lead inspection preparation activities and participate in mock audits.
Investigations:
- Conduct thorough investigations into deviations, non-conformances, and complaints using root cause analysis methods.
- Document investigation findings and recommend appropriate actions.
CAPA:
- Manage the CAPA process including initiation, tracking, and verification of effectiveness for corrective and preventive actions.
- Collaborate with cross-functional teams to resolve issues and implement improvements.
- Maintain accurate records of quality activities and critical incidents.
- Provide training and guidance to staff regarding quality systems and inspection readiness.
- Support other quality-related functions as needed.
Qualifications & Experience:
- Bachelor’s degree in Life Sciences, Engineering, or related field (preferred).
- Minimum of 2 years in a Quality Assurance role within regulated industry (pharmaceutical, biotechnology, medical device, etc.).
- Experience with regulatory inspection processes and requirements.
- Knowledge of investigations and CAPA methodologies.
- Familiarity with GMP, ISO, FDA, or similar standards.
Skills & Competencies:
- Strong analytical skills; ability to conduct root cause analysis.
- Excellent organizational and documentation abilities.
- Effective communication skills for cross-functional collaboration.
- High attention to detail and accuracy.
- Ability to prioritize and manage multiple tasks.
