Quality Control Analyst

2 weeks ago

Dublin, Dublin City, Ireland Independent Solutions Full time
Overview

QC Bioanalytical Analyst responsible for performing analytical testing within the Biologics laboratory.

Start Date - ASAP

Location - Dublin, Ireland

Duration - 11 Months (FTC)

Responsibilities
  • Perform and carry out a variety of routine analytical techniques, including but not limited to HPLC, Compendials, UV, Raw Materials, DNA PCR, and Bioassay ELISA testing in compliance with GMP requirements.
  • Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations, and industry standards.
  • Support the laboratory testing schedule to achieve an efficient QC system.
  • Receive and manage samples that come into the lab for stability, in-process and release testing.
  • Reagent preparation, cleaning, and routine equipment maintenance.
  • Maintain good housekeeping and hygiene within the laboratory.
  • Calibrate and maintain all designated laboratory instruments.
  • Participate in risk assessments, inspections, audits, incident investigations, and implement and follow up on corrective/preventative measures.
  • Ensure training is current for all job functions performed.
  • Order, stock, and receive laboratory supplies.
  • Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
  • Ensure that cGMP standards are always maintained.
  • Promote and participate in the implementation and maintenance of the relevant safety programs.
Experience, Knowledge & Skills
  • 1 - 5 years of laboratory testing experience in the pharmaceutical industry.
  • Relevant experience and skill set in their area of expertise that add value to the business; ideally in a manufacturing, preferably in a GMP setting.
  • Experience and critical skills in the area of expertise that add value to the business; ideally, bioassay and DNA tests.
  • Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
  • Knowledge of cGMP & Laboratory Quality Systems.
  • Effective communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.
Qualifications & Education

Qualification in Science/Chemical Engineering/Biological Engineering.

Seniority level
  • Associate
Employment type
  • Contract
Job function
  • Quality Assurance, Product Management, and Science
Industries
  • Pharmaceutical Manufacturing
  • Biotechnology Research
  • Medical Equipment Manufacturing

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