Key Responsibilities :
- Interpret GC-MS data (primarily EI) for identification of unknowns using spectral deconvolution and comparison to library databases for chemical characterization studies.
- Evaluate spectral quality, match scores, and fragmentation patterns using a weight-of-evidence approach, including critical assessment of database matches.
- Apply knowledge of retention indices and chromatographic behavior to confirm compound identity.
- Collaborate with technical analysts, chemists, and project managers to communicate findings, resolve discrepancies, and meet client expectations.
- Ensure data integrity and compliance with regulatory and accreditation standards (e.g., ISO 10993, ISO 17025, GLP).
- Document findings in established systems, supporting traceability and reporting.
- Contribute to method development and optimization by providing feedback on spectral data trends and anomalies.
- Support improvement of SOPs, templates, and data analysis workflows.
- Identify and troubleshoot potential prep or instrument-related issues affecting data integrity.
- Participate in continuous improvement initiatives and inter-laboratory collaborations.
- Other duties as assigned by management.
Additional Knowledge / Qualifications :
BS / B.Sc in Chemistry or a related field with 5+ years relevant experience, or MSc. / PhD with 2+ years of relevant experience.Proficient in interpreting GC-MS and chromatographic data.Experience working in a regulated environment (ISO 17025, ISO 10993, GLP / GMP).Familiarity with Microsoft Excel for data documentation and review.Preferred Candidate :
Background in organic chemistry, including fragmentation patterns under EI / CI, volatility, retention index behavior.Experience with extractables & leachables, particularly in a medical device or pharmaceutical context.Understanding of instrumental analysis workflows and solution preparation.Awareness of how sample prep or instrument anomalies affect data outcomes.Familiarity with relevant databases and software for compound identification.