Deviations Investigator

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices.

About the role

This role will be hybrid, with two weeks onsite and one week remote in Indianapolis.

Responsibilities

• Develop the Investigation Plan and present the Investigation Plan to management or CAPA review board
• Determine the Define/Measure/Analyze elements of the investigation
• Determine scope of the investigation
• Assume ownership and lead the Investigation phase of a CAPA
• Identify appropriate/cross-functional team members and assemble the Investigation Team
• Confirm corrections/containment identified based on the investigation results
• Identify and employ appropriate investigation tools
• Determine the appropriate data sources to be evaluated for the investigation, and obtain the required data
• Investigate the root cause(s) of the issue
• Clearly document the investigation results
• Communicate the investigation results to affected departments
• Ensure investigation follows the CAPA procedure, including all data entry requirements
• Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
• Collaborate with Action Owner/CAPA Owner to develop the Action Plan/Effectiveness Plan
• Document Action Plan
• Document Effectiveness Plan, including acceptance criteria and timeframe/number of opportunities

Requirements

• At least 3 years of experience in investigations for pharma/biotech
• Science related degree

Benefits

• Competitive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance
• 401(k) plan with employer match
• Generous paid time off policy for full-time employees
• Additional perks
• Opportunities for professional growth and advancement within a supportive and innovative environment
• Flexible work arrangements and a commitment to maintaining a healthy work-life balance