Investigator I / II

Shift details: Monday-Friday. There is flexibility to work from 8 am to 5 pm or 7 am to 4 pm. There may be an occasional need for weekend and after-hours support.

What You'll Do

• Lead investigations for quality deviations, safety incidents, alert actions, and remedial action requests across manufacturing operations
• Conduct interviews, gather and analyze data, facilitate investigation meetings, and apply systematic cause analysis methodologies to identify root and contributing causes
• Author clear, concise, and compliant investigation reports within designated quality and safety systems
• Partner with cross-functional stakeholders to develop effective corrective and preventive actions (CAPAs) that reduce recurrence risk
• Ensure investigations are completed in alignment with Quality Management System (QMS) requirements, regulatory expectations, and established timelines
• Share investigative findings and lessons learned across the organization to drive continuous improvement and operational excellence
• Support complex and high-impact investigations as needed
• Present investigation outcomes and supporting documentation during internal and external audits

Who You Are

You are a curious problem solver who enjoys uncovering the underlying causes of complex operational events. You are skilled at facilitating discussions, gathering insights from multiple stakeholders, and translating technical information into actionable recommendations. You thrive in a collaborative environment and are motivated by improving systems, processes, and organizational performance.

Required Skills for an Investigator I

Pay Range $69,000 - $90,000

The following combination of academic and/or relevant experience may be considered:

• Bachelor’s degree from an accredited college or university, STEM preferred
• Associate's degree, STEM preferred and at minimum 2 years of direct experience
• A High School Diploma (or equivalent) and at minimum of 4 years of direct experience
• Experience conducting investigations, root cause analyses, or operational problem-solving activities within regulated environments
• Strong analytical and critical thinking skills with the ability to evaluate complex information and develop practical solutions
• Excellent technical writing and documentation abilities
• Strong facilitation, communication, and stakeholder management skills
• Ability to effectively collaborate across multiple functions and levels of the organization
• Working knowledge of quality systems, safety programs, and compliance requirements within manufacturing, laboratory, industrial, or regulated environments
• Demonstrated ability to manage multiple priorities and meet critical deadlines

Required Skills for an Investigator II

Pay Range $85,000 - $111,000

The following combination of academic and/or relevant experience may be considered:

• Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 2 years of direct experience
• Associate's degree, STEM preferred and at minimum 4 years of direct experience
• A High School Diploma (or equivalent) and at minimum of 6 years of direct experience
• Experience conducting investigations, root cause analyses, or operational problem-solving activities within regulated environments
• Strong analytical and critical thinking skills with the ability to evaluate complex information and develop practical solutions
• Excellent technical writing and documentation abilities
• Strong facilitation, communication, and stakeholder management skills
• Ability to effectively collaborate across multiple functions and levels of the organization
• Working knowledge of quality systems, safety programs, and compliance requirements within manufacturing, laboratory, industrial, or regulated environments
• Demonstrated ability to manage multiple priorities and meet critical deadlines

Preferred Skills

• Experience with Human & Organizational Performance (HOP) principles
• Knowledge of systematic cause analysis methodologies such as Event & Causal Factor Charting, Logic Fault Tree Analysis, or similar techniques
• Experience supporting manufacturing, pharmaceutical, biotechnology, chemical, industrial, or other highly regulated operations
• Knowledge of cGMP, cGLP, OSHA, EMA, FDA, or similar regulatory requirements
• Experience participating in regulatory inspections or audits