What We're Looking For
We are seeking a highly skilled and detail-oriented Investigation Specialist with expertise in Analytical Chemistry to join our team. This role is responsible for leading and supporting investigations related to laboratory deviations, out-of-specification (OOS) results, and other quality-related issues. The ideal candidate will possess strong analytical capabilities, a thorough understanding of laboratory operations, and the ability to interpret complex scientific data to drive effective root cause analysis and corrective actions.
What You Will Do
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Lead, conduct, and document investigations into laboratory deviations, non-conformances, OOS/OOT (Out-of-Trend) results, and quality events.
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Perform detailed root cause analysis using analytical data, laboratory records, and supporting documentation.
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Analyze and interpret complex analytical chemistry data to identify trends, anomalies, and potential risks.
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Develop, recommend, and track corrective and preventive actions (CAPAs) to ensure timely and effective resolution.
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Prepare clear, concise, and compliant investigation reports in accordance with internal procedures and regulatory requirements.
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Collaborate cross-functionally with Quality Assurance, Production, R&D, and Regulatory Affairs to support investigations and implement solutions.
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Ensure investigations are completed within established timelines and meet compliance standards.
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Support internal and external audits by providing documentation and subject matter expertise as needed.
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Identify recurring issues or trends and contribute to continuous improvement initiatives.
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Maintain a strong understanding of current regulatory guidelines and industry best practices related to analytical chemistry and quality systems.
Who You Are
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Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline (Master’s degree preferred).
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3–5+ years of experience in a regulated laboratory environment (e.g., pharmaceutical, biotechnology, or related industry).
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Strong knowledge of analytical techniques such as HPLC, GC, UV-Vis, FTIR, or similar instrumentation.
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Experience with OOS, deviation investigations, and CAPA processes.
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Familiarity with GMP (Good Manufacturing Practices) and relevant regulatory requirements (e.g., FDA, ICH).
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Excellent problem-solving, critical thinking, and analytical skills.
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Strong written and verbal communication skills with the ability to clearly document findings.
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High attention to detail and strong organizational skills.
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Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
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Experience in method validation, method transfer, or stability testing.
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Prior involvement in regulatory inspections or audits.
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Knowledge of statistical analysis tools and trending methodologies.
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Laboratory and office-based role with regular interaction across multiple departments.
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May require occasional extended hours to support critical investigations or deadlines.
Who We Are
Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at www.eagleanalytical.com.
