Quality , Science, Pharmaceutical & Food

QC Analyst HPLC

  • Full Time
  • Remote
  • Cork
  • 41827962

POSITION SUMMARY:

Under general direction of the Laboratory Manager, and reporting to the Laboratory Supervisor, you will be primarily responsible for Quality Control testing in launching finished product; routine testing of finished product and compliance with cGMP’s. In addition you will support the regulatory requirements of finished product, supplier management and investigation of product issues.

This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate’s responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Ensures compliance with cGMP’s, Environmental, Health & Safety regulations.
  • Executes all Quality Control activities to ensure timely & compliant launch of finished products.
  • Executes all routine Quality Control testing to ensure timely & compliant release of finished products.
  • Executes the finished product Exception Program.
  • Supports regulatory requirements of finished products
  • Supports the timely receipt and release of finished products.
  • Prepares and executes method development, validation plans and protocols for the laboratory.
  • Supports the document control system & record retention.
  • Ensures laboratory equipment is calibrated & properly maintained at all times
  • Executes and supports batch record reviews to ensure timely release of finished product according to schedule

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

BSc in a scientific discipline; minimum of two (2) years in a cGMP facility in a Quality Control role. Experience in HPLC (High Performance Liquid Chromatography) is required.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

  • Ability to effectively participate in cross-functional problem solving teams
  • Ability to read and understand the English language for the purpose of following instructions
  • Ability to handle a variety of tasks simultaneously
  • Good problem solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
  • Good knowledge of Quality Assurance, cGMP and GLP.
  • Experience in using HPLC in a GMP environment is essential

Interested candidates should submit an up to date CV to Sean.Barron@peglobal.net or call Sean on 0214297900

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