Element has an opportunity for a Chemist 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 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 position is $27.00/hr - $35.00/hr.
Responsibilities:
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
Expertise in ICPMS analysis on pharmaceutical products preferred.
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
We are an equal opportunities employer and welcome applications from all qualified candidates.
