QC Associate

PE Global are currently recruiting for a Senior QC Associate for a client site in South Dublin.

QC Associate – Cell Potency/Cell Culture
12 Month Contract

Overview

The QC Associate will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, with minimal supervision, acting as a role model for other lab colleagues. The QC Associate undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT). The QC Associate also represents the QC unit by liaising with internal and external customers. The applicant must have Cell based potency bioassays, Cell culture, GMP/GDP & Elisa experience

Key Responsibilities:

• Experience in a wide variety of analytical techniques including but not limited to cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique. Experience with liquid-handling robots is also preferable.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Participate in the peer review of analytical data.
• Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
• Lead training of staff on technical aspects of job as required.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Qualification of analytical equipment and related testing functions.
• Participate in Analytical Method Transfers
• Compliance with Standard Operating Procedures and Registered specifications.
• Ensure the laboratory is operated in a safe manner
• Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
• Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
• Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
• Participate in regulatory agency inspections as required.
• Plan and implement procedures and systems to maximise operating efficiency.
• Manage and contribute to the achievements of department productivity and quality goals.

Qualifications & Experience

• Bachelor’s degree in a science discipline
• Biopharmaceutical QC experience
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
• Proficient in the use of LIMS & LMES

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

Interested candidates should send their CV to sean.fitzsimons@peglobal.net or call 0214297900