LabVantage Deployment Lead - GMP & Data SME

BioSpace; Indianapolis (IN); On-site; USD 63,000 - 162,800; Full time

Benefits offered by this job

401(k)

Pension

Health benefits

Flexible benefits

Life insurance

Paid time off

Well-being programs

Job summary

A global healthcare company in Indianapolis seeks a LabVantage Deployment Specialist. The role involves overseeing LabVantage implementation at sites, ensuring compliance with GMP requirements, and providing ongoing support. Candidates should possess a bachelor's degree and a strong background in laboratory operations. This position offers competitive compensation with a range of $63,000 - $162,800, along with potential bonuses and comprehensive benefits.

Responsibilities

• Lead the sites on the implementation of LabVantage through the different phases of deployment.
• Act as SME in QA, QC Lab, or Stability.
• Assist sites during data discovery to identify master data elements.
• Evaluate feasibility and global impact of site change requests.
• Work with project manager to identify and report key process indicators.
• Collaborate with and manage third-party partners.
• Ensure LabVantage processes are compliant with data integrity and GMP requirements.
• Understand local requirements and communicate changes to promote adoption.
• Provide ongoing support and issue resolution for LabVantage.
• Raise issues to the Site Council and/or LabVantage leadership team.
• Share best practices to promote transferable processes.
• Provide answers during inspections and audits.

Skills

Experience working in/with GMP laboratories

Strong scientific background

Clear understanding of quality laboratory issues and activities

Experience in defining and improving business processes

Knowledge of cGMP and quality systems

Solid understanding of GMP requirements and data integrity principles

Proven ability to work with computer systems and adapt them to business processes

Knowledge of product release processes

Experience managing stability programs

Ability to manage multiple priorities simultaneously

Education

Bachelor's degree

Bachelor's degree in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related field

Job description

A global healthcare company in Indianapolis seeks a LabVantage Deployment Specialist. The role involves overseeing LabVantage implementation at sites, ensuring compliance with GMP requirements, and providing ongoing support. Candidates should possess a bachelor's degree and a strong background in laboratory operations. This position offers competitive compensation with a range of $63,000 - $162,800, along with potential bonuses and comprehensive benefits.