Description:
There is an opportunity for a scientist to serve as Analytical Lab Operations Coordinator in the Regulatory Analytical Sciences Team within Global Regulatory Sciences R&D.
Specifically, we are seeking a technician with strong instrument maintenance and software installation experience, preferably in a regulated environment.
• Weekly Schedule (how many hours/days): 40 hours
• Shift Times: 8AM - 5PM
• Any specific skills, requirements or experience you want in a candidate: AS/BS/MS Chemistry. PhD candidates are likely overqualified for this role.
• Any additional Medical Surveillance testing required? No
• Any exposure to common allergens? Plants, Chemicals, Latex
Manager Note 10/28: We are specifically looking for candidates that have substantial analytical instrumentation maintenance/cleaning/upkeep/troubleshooting experience. This instrumentation experience is mainly for LC-MS/MS systems, but other experience could be applied to our lab. Daily calibration checks were listed on numerous resumes, but isn't really applicable to our needs. Anyone that has experience in PM/IQ/OQ/PQ of analytical instrumentation would be a good fit.
Primary Responsibilities
• Manage routine maintenance for several instrument systems including LC-MS/MS, GC-MS/MS, electronic and mechanical pipettes, sample grinding/preparation, evaporators, etc.
• Coordinate with internal resources and external vendors to repair, maintain, and upgrade instrumentation.
• Assist with major LC-MS/MS software upgrade initiative tied to Windows 11 compliance. This project will require coordination with external and internal partners to schedule, upgrade, and validate each instrument.
• Order supplies required for performing method development and assist with maintenance of equipment needed for this task.
• Follow specific protocols to perform routine lab support tasks including the following:
o Equipment, maintenance and validation
o Instrument cleaning and performance verification
o Computer systems validation
o LC-MS/MS batch setup and execution
o Mobile phase preparations
• Comply with all laboratory safety procedures, GLP Standards, and all other study-specific or pertinent regulatory agency requirements Documents activities in the required manner. Maintenance of neat, accurate, and complete records.
• As needed, follow Good Laboratory Procedures (GLP) and prepare related support documentation.
• Additional responsibilities could include:
o Standard solutions preparation
o Maintaining catalog and GLP documentation with respect to chemical standards and solutions.
Job Qualification
Required Qualifications:
• Minimum of an Associate Degree in a science related field, BS preferred.
• General knowledge of mass spectrometry, liquid chromatography and associated software.
• Ability to manage routine instrument upkeep and maintenance in a fast-paced, regulated, and time sensitive environment.
• Hands-on analytical laboratory experience is highly desired.
Preferred Qualifications:
• Experience with quantitative weighings, solution preparations for various analytical techniques.
• Quantitative LC-MS/MS analytical experience in small molecules.
• An understanding of GLP regulations.
• Excellent interpersonal skills. Must be able to effectively interact with a diverse group of customers, peers, and R&D regulatory and residue experts.
