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QC Specialist

2 weeks ago


Cork, Cork, Ireland beBee Careers Full time

Analytical Quality Assurance Specialist

Main Objectives:

  • Evaluate and improve analytical methods to ensure quality and consistency.
  • Analyze quality control issues and implement corrective actions.
  • Develop and maintain analytical documents and procedures.
  • Qualify and validate analytical equipment for accuracy and reliability.
  • Train and mentor personnel in analytical techniques and documentation.
  • Review and approve team member documentation as required.

Compliance and Governance:

  • Establish and maintain accurate documentation, including SOPs and validation records.
  • Own quality systems actions (IR's, CAPA, CC) to ensure timely resolution and performance tracking.
  • Participate in internal and external audits and address audit findings.
  • Identify opportunities for process improvement and implement changes for increased efficiency and compliance.

Background and Qualifications:

  • Minimum 2 years of experience in the pharmaceutical or medical device industry.
  • Degree (or equivalent) in Chemistry, Microbiology, or related field.
  • Experience in analytical quality assurance with focus on quality control and method evaluation.
  • Proven expertise in analytical equipment qualification and data integrity.
  • Familiarity with QC systems and processes, particularly LIMS, MODA, and Veeva.
  • Track record of data compilation, review, and reporting.
  • Knowledge of data integrity requirements for QC and regulatory compliance.
  • Project management skills, including leadership, oversight, and collaborative roles.

Skills and Expertise:

  • High level of attention to detail with emphasis on precision and accuracy.
  • Self-motivated and goal-oriented with high accountability.
  • Technical problem-solving skills with ability to analyze complex data sets.
  • Strong organizational skills with ability to prioritize tasks and manage multiple projects.
  • Ability to work collaboratively in a team environment.