Involves conducting chemical and physical analyses in a production site laboratory. Responsibilities include performing product release and in- process control tests, conducting stability tests, maintaining and calibrating analytical equipment, managing sample administration in SAP/LIMS, and performing root cause analyses for nonconformities. Additionally, the role supports GMP operations through computer system validation, method validation, raw data control and archiving, and the creation of GMP documents and regulations. The primary responsibilities of this role, Lab Analyst I, are to: Perform routine analytical testing as directed by protocols and work instructions; Work a variety of shifts (including weekends and holidays); Request additional work to increase team productivity; Prepare solutions, clean glassware, dispose of solid/liquid waste and other duties to help in the overall operations of the laboratory; Train others on waste management; Alert lab leadership of issues or discrepancies involving sample integrity, supply inventory, safety concerns, or analysis irregularities; Communicate troubleshooting opportunities in testing processes; Perform routine analytical testing as directed by protocols and work instructions; Work a variety of shifts (including weekends and holidays); Request additional work to increase team productivity; Conduct basic (operational) preventative maintenance according to work instructions. Identify and communicate operational issues of laboratory instruments and equipment KPIs. Understand and operate the Laboratory Information Management System (LIMS), Chromatography Data System (CDS) system, and other instrument specific computer systems; Search various databases for test methods, specifications, and standards to locate information required to complete analyses; Promptly and accurately record, calculate, and report analytical results; Review analytical data and various LIMS reports; Communicate and discuss any issues with team members and the supervisor; Complete data entry for metrics and KPIs. Identify process improvement ideas and communicate opportunities; Assist in improving established procedures and implementing continuous improvement projects; Communicate testing results to customers as required; act with customers in mind. Notify leads when supplies/consumables are at critical levels; Observe good safety and housekeeping practices; Participate in lab/site safety programs and cross-site initiatives; Maintain knowledge of RCRA hazardous waste regulations, waste determinations, waste codes, and how to immediately communicate the discovery of spills and leaks.
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Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees