Sr. Lab Analyst

Role Specific Responsibilities

• Lead the setup, daily tuning, and routine operation of ICP-MS and other specialized analytical equipment such as AA, GC, HPLC, etc.
• Perform analytical and wet chemistry testing in accordance with approved methods and specifications.
• Design and develop robust analytical methods for trace elemental analysis using ICP-MS across various matrices.
• Author and execute validation protocols in accordance with ICH and USP guidelines.
• Establish appropriate digestion techniques (e.g., microwave-assisted, open-vessel) and optimize collision/reaction cell parameters (KED/CRI) to mitigate polyatomic interferences.
• Prioritize and coordinate daily QC laboratory activities with the Quality Unit including sample testing, data review, documentation and timely batch release.
• Perform complex troubleshooting of instrument hardware and software.
• Review and approve analytical data batches for accuracy, ensuring full adherence to data integrity principles and CGMP.
• Oversee the preventive maintenance schedule and calibration programs for laboratory instrumentation to ensure zero downtime.
• Oversee the stability testing program and ensure compliance.
• Manage relationships with external service providers and coordinate equipment qualification activities (IQ/OQ/PQ) for new equipment installations.
• Maintain inventory of NIST standards and reagents for calibration.
• Develop and deliver technical training programs for Lab Analysts on elemental testing, equipment maintenance, and sample preparation techniques.
• Serve as the technical lead during internal and external audits (e.g., FDA, ISO, Customer Audits).
• Mentor staff on proper laboratory safety and hygiene and the "trace-metal mindset" required for ppb/ppt-level analysis.
• Support investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and corrective and preventive actions (CAPAs).
• Collaborate effectively with cross-functional teams including Manufacturing, QA, Supply Chain, Warehouse and EH&S.

Problem Solving and Innovation

• Complies with company Health, Safety and Environmental policies, procedures and arrangements.
• Reports all Health, Safety and Environmental accidents, incidents and near misses promptly.
• Acts in a safe and responsible manner at all times.

Education and Qualifications

• Active participation within continuous improvement activities.
• Participates in problem solving.
• Takes responsibility and ownership for own learning and development in the spirit of continuous improvement of both self and the business.
• Affords assistance in the training, mentoring and assessment of other team members.
• Exercises autonomy and judgement subject to overall direction or guidance.

Experience

• B.S./M.S. in Chemistry, Analytical Chemistry, or a related scientific field.
• Strong working knowledge of cGMP regulations and laboratory compliance.
• Demonstrated ability to operate independently or in a team environment.

Knowledge, Skills, and Abilities

• 5–8 years in an analytical laboratory environment, with a minimum of 3 years of hands-on expertise specifically in ICP-MS, HPLC, GC, AA and wet chemistry testing.
• Deep understanding of cGMP and pharmacopeial requirements (USP, EP, JP) for elemental impurities.
• Familiarity with method development, validation and stability testing activities.