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Job Title:

 

 

Senior Trace Metal Specialist

 

 

 

Reports To:

 

 

Compliance Chemist 

 

 

 

Direct Reports:

 

 

N/A

 

 

 

Emergency / Absentee Backup:

 

 

Compliance Chemist/QC Analysts

 

 

 

Job Summary:

 

 

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.

 

 

 

Essential Duties and Responsibilities:

 

 

·   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

 

 

 

Qualifications:

 

 

·    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

 

 

 

Physical Requirements:

 

 

·    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

 

 

 

Work Hours & Schedule:

 

 

·    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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Wind Gap

Rensselaer, NY

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