LIMS Project Manager

LIMS Project Manager

Onsite Role

Responsibilities/Deliverables:

• Project Manager for deployment of LabVantage LIMS/LES at site.
• Participates in global meetings for LabVantage LIMS and communicates information to local team.
• Leads local site meetings with cross-functional teams to develop project plans and track deadlines for LIMS implementation.
• Supports builds of master data by collecting feedback from local site.
• Able to review and understand basic and advanced topics with LIMS development.
• Partners and builds relationships with Local Quality Laboratory and View email address on click.appcast.io team.
• Authors and reviews documents for equipment and software interfaced with LIMS system.
• Provides oversight and supports continuous improvement of quality systems as they relate to the QC lab.
• Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices
• Implements and complies with corporate, site, and laboratory safety standards.
• Develops training materials for local site training of LabVantage.

Education/Experience:

• Bachelor's degree in Scientific Field
• 7+ years in pharmaceutical leadership with Quality Control experience, including leading or working effectively with a cross-functional group.
• 1+ years with project management
• Additional Skills/Preferences:

• Deep understanding of compliance requirements and regulatory expectations
• Demonstrated accuracy and proficiency in analytical skills.
• Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
• Excellent written and oral communication skills
• Previous LEAN experience: ability to drive continuous improvement.
• Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems.
• Strong technical aptitude and ability to train and mentor others.
• Project management experience
• Demonstrated problem-solving and decision-making capability.
• Demonstrated technical writing skills