Responsible for the proper testing and disposition of raw material, in-process and finished product according to all applicable procedures and guidelines. Performs all aspects of test procedures used, including preparation of solutions and samples, maintenance and calibration of analytical instruments, and interpretation of statistical analyses/results. Prepares and revises test procedures for the laboratory as required. Coordinates laboratory activities and work flow as deemed necessary with other QC laboratory personnel. ESSENTIAL RESPONSIBILITIES & FUNCTIONS include the following. Others may be assigned. Performs analysis on bulk and packaged final products utilizing methods that comply with regulatory, compendial (i.e., FCC, USP/NF, EP) or organizational requirements. Performs analysis on in-process samples to monitor and/or confirm that manufacturing specifications are being met. Participates in SQC charting of control samples; analyzing variations; and troubleshooting when necessary. Assures proper quality control of finished product for shipment and releases material in LIMS (Laboratory Information Management System) and SAP (Inventory Management System) as authorized by lab or quality management. Performs calibration, maintenance, basic diagnostic, and troubleshooting procedures for laboratory instruments as needed. Assists in managing the Laboratory Information Management System (LIMS). Generates Certificates of Analysis using the lab computer systems that comply with customer specifications. In the absence of the QC laboratory supervisor, coordinates laboratory activities and work flow as directed. Assesses Out-of-Specifications (OOS) results, determines the impact on the product, and ensures timely resolution or corrective action as needed. Establishes and maintains laboratory supply inventory. Prepares samples along with necessary paperwork for shipment to potential customers as requested. Maintains historical records by implementing record keeping systems and filing documents. Maintains general housekeeping tasks to assure a clean and organized work area. Performs all activities in a safe and conscientious manner. Understands and follows all organizational policies, procedures and rules, ensuring that all laws are obeyed and equal employment, safety and environmental protection are practiced. Must be able to work in excess of eight hours per day or forty hours per week on any shift or travel as needed. Normal work schedule includes rotating 1st , 2nd, 3rd shifts and on-call duty as required. Consistently demonstrates prompt, regular and reliable attendance. Communicates development and career goals to immediate supervisor and takes ownership of personal development plan. Contributes to team efforts by accomplishing related results as needed. Able to handle change productively and other tasks as assigned.
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Job Type
Full-time
Career Level
Entry Level
Number of Employees
501-1,000 employees