Lead Investigator - Pharmaceuticals

Kelly Services

Olde West Chester (OH)

On-site

USD 44,000 - 50,000

Full time

14 days+
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Job summary

Kelly Scientific seeks a Lead Investigator in Cincinnati, OH, for a 6-12 month contract to manage detailed deviations in pharma manufacturing. You will lead investigations, document findings with root cause analysis and CAPA actions, and collaborate with specialists to improve processes and compliance.

The role requires strong technical analysis, clear communication, and a proactive ownership mindset, with proficiency in MS Office and a willingness to learn QMS systems such as Veeva.

Qualifications

  • Strong technical analysis skills to assess complex data and conduct thorough investigations.
  • Excellent communication to present findings and recommendations clearly.
  • Ability to work in a fast-paced, evolving environment with accountability.
  • Willingness to learn QMS systems such as Veeva and use MS Office daily.
  • Bachelor’s degree in Science, Engineering, or related technical field is preferred.

Responsibilities

  • Lead detailed investigations with a defined scope, strategy, and timeline and update stakeholders on progress.
  • Write robust reports documenting findings, root cause analysis, CAPA actions, and preventive measures.
  • Collaborate with internal and external experts to enhance investigation speed and quality.
  • Coordinate with cross-functional teams to develop communication plans and actionable investigation plans.

Skills

Technical analysis
Communication
Ownership
MS Office
QMS learning

Education

Bachelor's degree in Science/Engineering

Tools

Veeva QMS

Job description

Join Our Team as a Lead Investigator!

Are you experienced in Deviation Remediation with a passion for improving Pharma Manufacturing processes? Kelly Scientific is excited to offer aLead Investigatorposition for individuals like you to work on non-critical deviations in a dynamic and supportive environment. This is a6-12 month contract rolethat includes theopportunity to contribute to impactful projects in the pharmaceutical industry.

Title:Lead Investigator
Location:Cincinnati, OH
Contract Duration:6 months minimum (1year anticipated)
Compensation:$32-$36/hour

What You’ll Do:

  • Take charge of detailed investigations with a clear scope, strategy, and timeline while keeping stakeholders updated on progress and status.
  • Write impactful reports that document your findings on product impact, root cause analysis, corrective actions, and preventive measures to ensure issues don’t recur.
  • Collaborate with internal and external experts to enhance the speed and quality of investigations.
  • Work closely with cross-functional teams to:
    • Develop a clear communication strategy to ensure stakeholders are well-informed.
    • Design actionable investigation plans, including defining problems and solutions.
    • Identify root causes and implement effective CAPA action plans with follow-up checks.
    • Manage priorities to ensure investigations are completed in a timely manner, escalating issues as needed.
  • Tackle new challenges and contribute to process improvements across the organization.

What We Need From You:

  • Required:
    • Strong technical analysis skills with the ability to assess and quickly assimilate complex data to conduct thorough investigations.
    • Excellent communication skills to present findings and recommendations in a concise and effective manner.
    • Ability to work efficiently in a fast-paced, rapidly changing environment.
    • Proactive approach with a strong sense of accountability and ownership throughout the investigation process.
    • Proficiency in Microsoft Office Suite and a willingness to learn QMS systems such as Veeva.
  • Preferred:
    • Background in Pharmaceutical Manufacturing or other regulated industries.
    • Familiarity with problem-solving tools and techniques.
    • Understanding of core business processes, including cGMP and regulatory requirements.
    • A Bachelor’s degree in Science, Engineering, or a related technical field.
    • Experience in Quality Deviation Management.

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