Job Title: |
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Senior Trace Metal Specialist
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Reports To: |
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Compliance Chemist
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Direct Reports: |
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N/A
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Emergency / Absentee Backup: |
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Compliance Chemist/QC Analysts
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Job Summary: |
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The Senior Trace Metal Specialist is responsible for trace metal analysis by ICP-MS and ICP-OES. The Senior Trace Metal Specialist will work directly with the Compliance Chemist to implement new methods, streamline existing methods, and assist with getting new instrumentation operational for trace metal analysis.
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Essential Duties and Responsibilities: |
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· Assist the QC analysts with troubleshooting the ICP instrumentation in the laboratory · Assist with product development projects including Solid Phase Extraction and metal scavenging studies · Assist with protocol generation, data review and the report generation for trace metal analysis · Assist with sourcing new instrumentation and getting it operational · Function as a trace metal analytical Subject matter Expert (SME) · Knowledge of USP <232><233> and ICH Q3D guidelines to ensure compliance · Train QC analysts to perform trace metal analysis · Other duties may be assigned as deemed appropriate by management. · Perform elemental impurity analysis on existing and new products · Perform method development feasibility studies and execute method protocols · Perform trace metal analysis on sample submission, if applicable · Review validation data and notebooks for completeness and accuracy |
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Qualifications: |
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· Bachelor’s degree or higher in Science Field, Chemistry Degree or other related field and/or commensurate experience required. · Experience in pharmaceutical or related industry in a laboratory setting, with knowledge of cGMP and related compliance regulations and guidance, is required. · Ability to interpret data, perform complicated analytical calculations and statistical analysis · Must be able to communicate technical, scientific, and regulatory information, both written and verbally · Must be able to work in a cross-functional environment to interact with multiple departments · Must be able to train QC analysis to perform trace metal analysis. · Prior experience in writing analytical protocols and reports · Prior experience with Trace metal, elemental impurity analysis, with a minimum of 3-5 years of direct hands-on trace metal experience in a GMP laboratory is required. · Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word
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Physical Requirements: |
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· Lift up to 20 lbs. · Bend, stoop, carry, and reach · Climb and/or stand on an elevated bench or step stool · Sit and/or stand for extended periods · Ability to see and distinguish color · Work with chemicals and/or hazardous materials
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Work Hours & Schedule: |
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· Exempt Position · Minimum of 40-45 Hours Week, or other agreed upon documented schedule · Ability and willingness to work from all BioSpectra facilities
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