Job Title: QC Analyst in Chemistry
CPL, in partnership with our Client Pfizer, is seeking a highly skilled QC Analyst to join their dedicated and effective quality control team at their state-of-the-art site in Dublin, Grange Castle. This is an on-site role for a contingent fixed-term contract.
Key Responsibilities:
* Develop and maintain quality programs, processes, and procedures ensuring compliance with established standards and agency guidelines.
* Contribute to quality risk management, commitment tracking, interpreting policies, managing site complaints, and providing process analysis oversight.
* Ensure quality assurance programs and policies are maintained and modified regularly, promoting uniform global standards and best practice sharing.
Your Expertise:
* Subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials, and equipment.
* Adapt standard methods and procedures by applying knowledge, prior work experience, and requirements.
* Make informed decisions on method and procedure suitability for different work situations.
Duties:
* Perform analysis of quality control samples, including raw materials, in-process, intermediates, stability, and finished products, adhering to Current Good Manufacturing Practices.
* Write up and execute analytical method transfer exercises for products transferred to the Grange Castle site, ensuring compliance with site, Pfizer Quality Standards, International Conference on Harmonization guidance, and filing requirements.
* Adhere to good laboratory practices and housekeeping standards.
* Assist in generating and maintaining quality procedures and reports.
* Facilitate laboratory investigations and support associated product investigations.
* Analyze wet chemistry and use analytical equipment, including UV, HPLC, FTIR, KF, iCE, ICP, CE, and compendial assays.
* Participate in Right First Time, Continuous Improvement, and unburdening activities to facilitate Lean/Agile implementation.
Qualifications:
* Third-level qualification in Science, Engineering, or equivalent preferred (not essential).
* Strong knowledge of analytical techniques, both theoretical and practical.
* Excellent interpersonal and communication skills.
* Detail-oriented, quick decision-making, self-motivated with good trouble-shooting and problem-solving abilities.
Nice-to-Have:
* Experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment.
* Some experience working in a QC laboratory or production environment preferred (not essential).
* Knowledge of computer applications, including MS Office, Excel, Laboratory Information Management System Access, and Trackwise.