Deviations Investigator

ELIQUENT Life Sciences; Bloomington (IN); Hybrid; USD 95,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

401(k) matching

Paid time off

Flexible work arrangements

Equal Opportunity Employer

Job summary

ELIQUENT Life Sciences is seeking a Deviations Investigator for our Indianapolis Consulting Team. This hybrid role entails leading CAPA investigations, defining analysis scope, assembling a cross-functional team, and documenting results to support quality and compliance.

Minimum of 3 years of pharma/biotech investigation experience with a science-related degree is required. The role offers a competitive salary and comprehensive benefits, with two weeks onsite and one week remote.

Qualifications

• Pharma/biotech investigation experience of 3+ years.

Responsibilities

• Develop the Investigation Plan and present it to management or CAPA review board.
• Determine the Define/Measure/Analyze elements of the investigation.
• Lead the Investigation phase of a CAPA and own its scope.
• Assemble the Investigation Team with cross-functional members.
• Confirm corrections/containment based on results.
• Utilize appropriate investigation tools and data sources.
• Investigate root causes and document results clearly.
• Communicate results to affected departments.
• Ensure adherence to CAPA procedures and data entry requirements.
• Maintain the Investigation record with current information.
• Collaborate to develop Action Plans and Effectiveness Plans.

Skills

Investigation experience

Education

Science-related degree

Job description

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. For more information, please visit our website at eliquent.com.

We are seeking a Deviations Investigator to join our Indianapolis Consulting Team. This role will be hybrid, with two weeks onsite, one week remote.

The Deviation Investigator will:

• 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

Qualifications:

• At least 3 years of experience in investigations for pharma/biotech with a science related degree

What We Offer:

Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy for full-time employees, and additional perks. Compensation is commensurate with professional experience.

Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.

Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.