Job Title: QC Analyst
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About the Company:
A global leader in pharmaceutical manufacturing, our Cashel site is dedicated to innovation and quality. We ensure the highest industry standards while delivering life-changing products worldwide.
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Job Summary:
We are hiring a QC Analyst to support laboratory setup, conduct essential testing, and ensure compliance with cGMP standards. This role offers an opportunity to work in a fast-paced environment and contribute to key quality operations.
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Key Responsibilities:
* Support laboratory setup and equipment qualification.
* Prepare and review laboratory procedures, protocols, and reports.
* Perform QC testing in line with SOPs, cGMP, and regulatory requirements.
* Conduct method verification, validation, and technical transfers.
* Manage laboratory consumables and ensure proper tracking.
* Assist in regulatory audits and maintain audit readiness.
* Collaborate with cross-functional teams, including technicians, operations, and warehouse staff.
* Maintain compliance with Good Documentation Practice (GDP) and Quality Management Systems (QMS).
* Ensure EHS standards are upheld in the laboratory.
* Liaise with CROs and conduct audits as needed.
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Requirements:
* Degree in Chemistry, Biochemistry, Pharmaceutical Science, or related field.
* Experience in a cGMP-regulated QC or ARD laboratory.
* Strong understanding of method validation, technical transfer, and regulatory compliance.
* Excellent documentation, reporting, and communication skills.
* Ability to manage multiple tasks in a fast-paced environment.
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Benefits:
* Competitive salary & annual bonus
* Flextime options for work-life balance
* Laya Healthcare for employee, partner & dependents
* 5% employer-matched pension plan
* Educational assistance & career development support