QC Lab Technician

Job Title Two of the headcount will work 2-2-3 (12:00 PM -00:30 AM) after a month on M-F (8 AM-4:30 PM) for onboarding and training. The third headcount will work 2-2-3 (06:00 AM -18:30 PM) after a month on M-F (8 AM-4:30 PM) for onboarding and training. Description: Supports testing a wide range of biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods. Position is applicable to QC Analytical Testing Primary Duties: Conduct critical biological, chemical and physical analyses of in-process and final products to support manufacturing facility production schedules. Perform documentation and review of test data following good documentation practices. Enter final data in LIMS and other computerized systems. Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles. Complete all testing, including special project / protocol testing in a timely and appropriate manner. Maintain data integrity and ensure compliance with company SOPs, product specifications, FDA, GLP, QSR and cGMP regulations. Investigate deviations and write exception documents. Participate in team functions to address production, increase efficiency, solve problems, generate cost savings and improve quality. Conduct other duties as assigned. Key Skills and Abilities: Proficiency in both manual methods and instrumentation analyses. Experience performing and analyzing analytical assays. Proficient in wet and instrumental methods of analyses. Knowledge of most laboratory equipment including but not limited to GC, HPLC, ICPMS and other analytical instruments Basic knowledge of statistical methods and strong technical problem solving skills. Ability to conduct multiple tasks concurrently to meet critical timelines. Effective communication skills, ability to train others. Proficient use of TrackWise, Empower, and MiniTab software a plus. Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Knowledge of basic chemical and biological safety procedures Good computer skills, knowledge of Microsoft Word, Excel and PowerPoint. Able to identify when proper practices/ procedures are not performed. Follow SOPs and generate results. General responsibilities include: General laboratory housekeeping. Cleaning of laboratory glassware and equipment. Operation of equipment preparation and cleaning systems in QC (QC glasswashers). Maintenance and stocking of departmental consumable inventory. Routine verification of operating parameters of temperature controlled units. Routine cleaning and maintenance of temperature controlled units. Perform non-batch release testing (e.g. raw materials, cleaning). Assist in filling and archiving of departmental data, binders, reports, investigations, etc. Maintenance and disposal of waste generated throughout the laboratory. Retrieves and receives all samples into the QC Laboratories. Logs samples into logbooks. Receives samples into LIMS, EBM, and/or JDE. Enter data into LIMS. Initiate and pull Stability Studies / Samples. May lift, push, pull and carry up to approximately 25 lbs. Will work around chemicals such as alcohol, acids, and buffers that may require respiratory protection. May be required to work or be assigned to a different shift to meet business needs. Must be willing to work off shifts hours. Must be able to work supplemental hours as necessary to complete work commitments. May be required to work in a confined area. Primarily inside working conditions. Some clean room and cool/hot storage conditions. LanceSoft