Quality Assurance Associate

LocationPortlaoise, Ireland
DepartmentQuality
Reports ToQuality Assurance Specialist
Position Overview

The Quality Assurance (QA) Associate will report directly to the QA Specialist and is responsible for supporting the Quality Management System by ensuring compliance with established procedures and quality/business requirements and supporting manufacturing operations.

Duties & Responsibilities
  • Document Management – e.g. – Batch Records, Labels, Supporting Documentation
    • Engaged with production, demonstrating strong process knowledge to issue & audit batch records, labels & supporting documentation per schedule & approved procedures
    • Control and issue batch records and labels in accordance with procedures
  • Change Control Process
    • Support Change Controls for SOPs, forms, & process, engaging with Product Manager. Manage appropriate approvals, review for applicability, maintain logs, and support closure of change control. Participate in change control committee
  • Deviations
    • Supporting the logging, tracking, & closing out of deviations. Participate in root cause analysis and corrective action development as needed
  • Document Archive/Management
    • Ensure controlled documents are correctly filed, archived, & maintained in accordance with ISO and GMP requirements
  • CAPA (Corrective and Preventative) Management
    • Maintain CAPA Log including customer’s complaints
    • Work with department managers/assigned parties to write action plans when needed
    • Support review of root causes and plans, evidence, verification of effectiveness.
    • Review trends and communicate concerns
  • Quality Management Inputs
    • Participate and support site on quality audits
    • Support Quality Agreement Process with Customer, Legal and Quality
  • Internal Auditor
    • Where required, support Internal Audit programme
  • Quality Management Inputs:
    • Participate and provide feedback at Quality management review.
Skills & Qualifications
  • Experience: 2-5 years in a regulated environment
  • Knowledge of GMP manufacturing processes an advantage
  • ISO 9001 and cGMP experience preferred
  • Proficient in Excel and Word
  • Strong communication and interpersonal skills
  • Proven work experience and qualifications as a collaborative and agile team member
  • Strong organization and time-management skills
  • Ability to thrive in a fast-paced environment
  • Attention to detail is a must.
Qualities
  • Possesses Company values of honesty, integrity, respect, commitment and open to change while modelling the Company Core Principles in all activities
  • Ability to foster collaborative, cross department relationships to meet common objectives.