We are seeking a Senior Associate Quality Control professional to join our team.
Job Description
A world-class manufacturing operation in Dublin is looking for an experienced Senior Associate Quality Control (QC) specialist to lead the calibration, qualification, and maintenance of laboratory equipment. The successful candidate will ensure that all equipment meets regulatory requirements and maintains its performance standards.
The role involves planning and conducting routine calibration and requalification activities, reviewing and filing QC documentation, and executing qualification protocols for new laboratory equipment in a cGMP environment. Additionally, the candidate will participate in technical project teams, provide subject matter expertise on instrument validation regulations, and support data integrity assessments for lab systems.
Required Skills and Qualifications
To be successful in this role, candidates should possess a Bachelor's degree in a Science-related field and have a minimum of 3 years of laboratory experience in a cGMP environment. They must have exposure to analytical instrument validation and data integrity assessments, as well as detailed knowledge of methodology, instrumentation, and analytical techniques used for biopharmaceutical testing.
Candidates with demonstrated success in managing an equipment qualification or maintenance program will be advantageous. A strong understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity is also essential.
Benefits
This is an excellent opportunity to work in a world-class manufacturing operation with a strong culture of continuous improvement and innovation. The company is committed to striving for solutions that improve health outcomes and dramatically improve people's lives.
In addition, the role offers a challenging and rewarding career path, with opportunities for professional growth and development. Candidates will have the chance to make a real impact on the organization's success and contribute to the production of high-quality medicines for patients around the world.