Lab Systems Lead, QC Technical Support (QC Lab Systems)

Reporting to the QCTS Manager, Lab Systems this role will be primarily responsible for coding and implementing QC test methods in an Electronic Lab Notebook (Biovia Smartlab).  Additional responsibilities include supporting and building methods for LIMS and Empower.  Incumbent may have other duties assigned and may participate on a variety of network teams (technical/ strategic) in support of business processes/improvements. KNOWLEDGE AND SKILL: Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline is preferred, or its equivalent. Working knowledge of databases and laboratory applications including LIMS, Biovia ELN (Smartlab), Aegis Discoverant, NuGenesis, and Waters Empower software desired. Knowledge of interfacing of the above applications and impact to each other. Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices Significant back room auditexperience. Can speak to a basic SOP in the front room. Minimum of 4-6 years of industry experience. MAJOR DUTIES AND RESONSIBILITIES: Provides Quality System input, support, training, and troubleshooting to the Analytical and Microbiology laboratories for data management systems.  This includes conversion of Electronic Lab Notebook (ELN - Smartlab) methods, Empower updates, LIMS static data builds, configuration of system reports, and updates to Aegis Discoverant. Sustains and enhances data management systems as required to support routine testing activities, method transfers and validations, and change control activities around these methods or systems. Applicable methods systems include, but not limited to HPLC, spectroscopy, ELISA, Bioassay, and GC methods. Communicates issues, technical failures, and projects status updates to direct supervisor. Review and implement change controls associated with these applications for impact the QC laboratories.  Assist in the definition of implementation plans as required. Perform project management activities in support of business process improvements. Represent QC laboratories at site, company and external system meeting. Duties may include internal compliance or efficiency improvement efforts within department. Performs broad range of troubleshooting techniques and leads such within area of expertise. CONTACTS: Work with Digital Plant / IT team regarding technical issues, upgrades and updates to systems as required. Work with the global IT team, QC Analytical and Microbiology teams.  Some contact with general business functions and BMS staff at other locations, including corporate headquarters.  Occasional contact with outside vendors and contact with representatives from health authorities / regulatory agencies during site audits. WORKING CONDITIONS: Work is largely performed in a modern office and a cGMP laboratory / manufacturing facility where one must maintain a high attention to detail and to be aware of the presence of workplace hazards including pressurized liquids gases, steam, biohazards and hazardous chemicals.  The use of Personal Protective Equipment (PPE) will be required in the laboratories and in some portions of the facility. R1511500
Salary Range: NA
Minimum Qualification
Less than 5 years

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