Overview
We are seeking a committed and motivated Chemist II to join our team. This role involves overseeing the day-to-day operation of the laboratory, scheduling testing, and analysts, and carrying out testing as required. The Chemist II will be the first point of contact for analysts on technical issues, coordinate stability testing, and provide support in areas such as cGMP, regulatory compliance, technical investigations, troubleshooting, and training.
Job Title: Chemist II
Location: Ireland - Cork
Duties
1. Oversee the daily operations of the laboratory, including scheduling testing and analysts.
2. Conduct analytical testing on commercial, stability, and non-routine samples.
3. Participate in test method development, validation, and technical transfers.
4. Provide technical guidance and troubleshooting support.
5. Ensure compliance with cGMP, regulatory requirements, and quality systems.
6. Maintain laboratory scorecards and trackers to ensure performance objectives are met.
7. Perform equipment calibration, qualification, and maintenance as needed.
8. Review laboratory quality systems and participate in regulatory and vendor audits.
9. Train and mentor laboratory staff, ensuring compliance with mandatory training requirements.
10. Support laboratory management in budgeting, procurement, and inventory control.
11. Participate in out-of-specification (OOS) investigations and corrective action implementation.
12. Represent the laboratory on cross-functional project teams and attend relevant meetings.
13. Lead or assist with laboratory continuous improvement initiatives.
Qualifications
1. BSc in Analytical Chemistry or a related science field.
2. 4+ years of experience in a GMP-regulated laboratory environment.
3. Experience with analytical techniques such as HPLC, FTIR, UV, and wet chemistry.
4. Preferred experience with GC, USP App-4, and KF coulometry.
5. Working knowledge of cGLP/cGMP and applicable FDA, EMA, and ICH guidelines.
6. Strong documentation and data management skills.
7. Excellent communication skills, both written and verbal.
8. Strong problem-solving abilities and technical acumen.
Who You Are
1. A detail-oriented professional with strong analytical skills.
2. A self-motivated individual who thrives in a fast-paced, regulated environment.
3. A strong team player with the ability to mentor and train others.
4. A problem solver who can troubleshoot and identify solutions efficiently.
Where You Come From
1. You have a background in analytical chemistry or a related scientific discipline.
2. You have experience in method development, validation, and stability coordination.
3. You are familiar with laboratory instrumentation and software applications.
4. You have prior experience working in a GMP-regulated laboratory setting.
What We Offer
1. Competitive salary and benefits package.
2. Opportunities for professional development and career growth.
3. A collaborative and innovative work environment committed to excellence.
4. A permanent full-time position with long-term career prospects.
We will only be replying to candidates who progress to the next stage.
Diversity and inclusion are essential to our mission and achieving our vision. The diversity we foster is one of our greatest strengths in delivering excellence through collaboration, respect, quality, and integrity without compromise. We are an Equal Opportunity Employer.
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