About This Role
We are seeking a highly skilled QC Separation Specialist to join our team in Cork, Ireland. As a key member of our quality control group, you will play a critical role in ensuring the accuracy and reliability of our biotechnology products.
Responsibilities
* Achieve high competency in laboratory methods and procedures to support in-process and release testing.
* Review and approve laboratory test results.
* Perform analytical testing activities for method validation and technical transfer, ensuring compliance with ICH, USP, and EP guidelines.
* Validate, operate, maintain, calibrate, and troubleshoot equipment and its associated software.
* Write and execute reports, reviewing IQ/OQ and PQ protocols to qualify relevant equipment for cGMP use.
* Ensure timely completion, review, and approval of all testing within agreed turnaround times.
* Implement QC activities in accordance with product license commitments, cGMP, and company quality standards.
* Train other QC analysts in laboratory methods and procedures when required.
* Develop and review TMs, SOPs, and WIs as needed.
* Address invalid assays, non-conformances, and deviations as necessary.
* Promote lean initiatives, such as Kaizen, 6S, and Gemba, within the QC group.
* Maintain and enhance knowledge of analytical technology and cGMP standards.
Requirements
* Bachelor's degree in a relevant field (e.g., chemistry, biology, or pharmaceutical sciences).
* Minimum 2 years of experience in a similar role, preferably in a GxP environment.
* Strong understanding of laboratory methods and procedures.
* Excellent analytical and problem-solving skills.
* Ability to work effectively in a team-oriented environment.
What We Offer
We provide a stimulating work environment, opportunities for professional growth, and a competitive compensation package.
This is an excellent opportunity for those looking to develop their expertise in quality control and contribute to the success of our organization.
Please submit your application, including your resume and a cover letter outlining your qualifications and experience.
We look forward to hearing from you.