What We're Looking ForWe 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- Lead, conduct, and document investigations into laboratory deviations, non-conformances, OOS/OOT (Out-of-Trend) results, and quality events.
- Perform detailed root cause analysis using analytical data, laboratory records, and supporting documentation.
- Analyze and interpret complex analytical chemistry data to identify trends, anomalies, and potential risks.
- Develop, recommend, and track corrective and preventive actions (CAPAs) to ensure timely and effective resolution.
- Prepare clear, concise, and compliant investigation reports in accordance with internal procedures and regulatory requirements.
- Collaborate cross-functionally with Quality Assurance, Production, R&D, and Regulatory Affairs to support investigations and implement solutions.
- Ensure investigations are completed within established timelines and meet compliance standards.
- Support internal and external audits by providing documentation and subject matter expertise as needed.
- Identify recurring issues or trends and contribute to continuous improvement initiatives.
- Maintain a strong understanding of current regulatory guidelines and industry best practices related to analytical chemistry and quality systems.
Who You Are- Bachelor's degree in Chemistry, Analytical Chemistry, or a related scientific discipline (Master's degree preferred).
- 3-5+ years of experience in a regulated laboratory environment (e.g., pharmaceutical, biotechnology, or related industry).
- Strong knowledge of analytical techniques such as HPLC, GC, UV-Vis, FTIR, or similar instrumentation.
- Experience with OOS, deviation investigations, and CAPA processes.
- Familiarity with GMP (Good Manufacturing Practices) and relevant regulatory requirements (e.g., FDA, ICH).
- Excellent problem-solving, critical thinking, and analytical skills.
- Strong written and verbal communication skills with the ability to clearly document findings.
- High attention to detail and strong organizational skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Experience in method validation, method transfer, or stability testing.
- Prior involvement in regulatory inspections or audits.
- Knowledge of statistical analysis tools and trending methodologies.
- Laboratory and office-based role with regular interaction across multiple departments.
- May require occasional extended hours to support critical investigations or deadlines.
