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