Job Description

Element has an opportunity for a Chemist I to join our growing team. This Chemist's main responsibility is to assist the Metals department in testing, sample preparation and preparation of test reports.

The Chemist I is responsible for performing testing in a pharmaceutical Quality Control laboratory. All work will be conducted in accordance with standard operating procedures and test methods. This includes performing testing on raw materials, pharmaceutical products, medical devices and other samples as needed. Execute compendia method validation, method transfers and routine testing to meet client requirements and in accordance to regulatory and company guidelines. Set up and confirm suitable operation of equipment and instrumentation. Collect data and generate/report results in accordance with governing test methods and SOP’s.

The pay range for this role is set between $27hr-$35hr, but will vary depending on level of experience.

• Performs analytical testing of incoming raw materials, release testing of pharmaceutical products and medical devices using ICP-OES and ICP-MS for trace metals analysis
• Conducts testing as per applicable regulatory and company guidelines
• Assists in the execution of method development, transfers, verification and validation as per applicable USP, ICH, and company standards
• Keep accurate, legible, complete, defensible, and complete records of all experiments and observations
• Assist in audit preparedness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed
• Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.

Requirements:

• Requires a minimum of a bachelor’s degree in Chemistry, or related field with 2-5 years of experience in pharmaceutical industry or other cGMP regulated environments
• Knowledge of analytical instrumentation including ICP-MS and ICP-OES preferred
• Understanding of good laboratory practices and analytical techniques
• Meticulous, detail oriented, punctual and willing to switch shift as needed
• Able to perform work under cGMP environment
• Excellent communication skills, written and verbal Excellent skills with Microsoft Office Suite of Products (Power Point, Word and Excel)
• Able to work overtime
• Enthusiastic team player, ready to step in wherever they are needed

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