Empower Specialist role
* Provide Empower 3.0 technical support in a GMP regulated environment globally.
* Applies knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory practices
* Working knowledge and proficiency with Microsoft Office software
* Writes and executes protocols and reports
Responsibilities include but not limited to:
* Supporting end user system needs (Level 1).
* Creating, reviewing, and locking Empower Instrument Methods, Method Sets and Processing templates.
* Trouble shooting all aspects of using Empower by end users.
* Trouble shooting instrument connectivity issues, custom field calculations, rebooting LACEs, and optimizing processing methods.
* Good working knowledge of laboratory testing processes and automation using Empower. Knowledge includes but not limited to: Fraction Collection, Mass Spec, Dissolution, Multi-Component analysis, Labware LIMS interface, and NuGenesis SDMS.
* Minimum 3 years' experience using the functionality of Empower in the pharmaceutical, biotechnology, or other related industry.
* Experience using NuGenesis SDMS and Labware LIMS preferred. * Experience in Quality Control laboratory environment preferred.
* Solid understanding of analytical chemistry and instrumental analysis. Hands-on proficiency and problem-solving skills with HPLC, GC, LC-MS and other chromatographic techniques. Familiarity with spectroscopic techniques is an advantage.
* Strong analytical, problem-solving and technical skills to develop practical solutions to business problems.
* Good working knowledge of laboratory testing processes and automation using various instrument software packages.
* Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), service management, IT project lifecycle and other regulatory requirements or policies
* Excellent verbal and written communication skills. Ability to work successfully independently and as part of a group. Ability to communicate effectively with technical and non-technical audiences.
Knowledge Experience Skills Experience in a support role is preferable bachelor's degree with 3 years of experience
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.