As an ICPMS Analyst you will perform analytical analysis of elemental impurities of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include but not be limited to compendial analysis and method development of elemental impurities and wet chemistry techniques used in raw materials. You will be performing analysis of Raw Materials using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development according to USP/EP methods.
Primary Duties and Responsibilities
- Set-up, perform, and/or supervise analytical testing.
- Prepares samples for analysis by ICP-MS.
- Analysis of sample solutions by ICP-MS to adequately resolve and identify all elements.
- Coordinate ICP-MS findings with sample data from other testing results including GC-MS and LC-MS analyses.
- Author detailed cGMP reports outlining study findings.
- Develop ICP-MS methods for drug product stability testing.
- Performs system maintenance and calibrations to ensure equipment is operating with specified requirements. Ensures all work performed strictly adheres to Company, client and Pharmacopeial requirements.
- Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
- Confers with chemists and other client personnel regarding research, procedures performed and related results and prepares technical papers and reports.
- As a subject matter expert, confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.
- Provides over site to projects and assist other Analysts as needed.
- Performs advanced data generation, analysis and solves complicated problem solving independently with minimal rework.
- Reviews and assesses discrepancies; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting.
- Supervises, trains, and mentors other chemists on an as needed basis.
- Documents work in a clear and organized manner.
- Follows all safety rules and regulations and conducts periodic safety audits.
- Follows all cGMP rules and regulations.
Qualifications include a Bachelor’s degree or higher in Chemistry related discipline, Master’s Degree in Analytical Chemistry a plus. Must have at least 2 years laboratory experience including hands on instrumental analysis (ICP/MS) interpreting, reporting and reviewing data generated by software, troubleshooting and training experience. Knowledge of cGMPs and related compliance regulations and guidance required.
Minimum Skills Requirements:
- Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
- A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
- Must have excellent organizational, verbal communication and technical documentation skills.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members.
- Demonstrated ICP-MS operation and data interpretation capability.
- Documented success managing complex projects to completion within customer expectations for deadline, cost, and overall deliverable.