Job Description
Quality Assurance Lead Investigator – Sharonville, OH
Kelly Scientific is searching for Lead Investigators with Pharma Manufacturing Quality experience to work on non-critical deviations.
- Title: Lead Investigator
- Location: Sharonville, Ohio Area
- Length of Assignment: 6-12 months
- Rate: $40-43/hr. with full benefits provided (PTO, insurance, etc.)
Responsibilities :
- Conducts organized investigations with a well-defined scope, strategy, and timeline documenting status and progress of the investigation.
- Authors reports that document the investigation of issues including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
- Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations.
- Collaborates with a cross functional team to determine:
- Communication strategy so all stakeholders have appropriate information.
- Investigation strategy including a clear and actionable problem statement.
- Investigation tools.
- Investigation action plan and timing.
- Root cause.
- Solution selection.
- CAPA action plan and effectiveness checks.
- Prioritizes work to aid in timely decisions and completion of investigations. Escalates issues as appropriate.
- Completes other duties as assigned.
Requirements:
- Bachelor’s degree, preferably in Science, Engineering, or other related technical discipline.
- Experience in Quality Deviation Management
- Experience in Pharmaceutical Manufacturing or other similar regulated industry.
- Familiarity with problem-solving tools.
- Understanding of the internal core business process including relevant cGMP and regulatory.
- Ability to quickly assess and assimilate technical data and conduct a thorough investigation
- Ability to present findings, conclusions, and complex information in a clear, concise, and logical manner.
- Excellent written and verbal communication skills, including technical writing capability.
- Ability to work in a fast-paced and rapidly changing environment.
- Ability to take accountability with excellent follow through, showing ownership through the full investigation process.
- Proficiency with Microsoft Office Suite and have a working knowledge, or the ability to learn, QMS systems such as Veeva
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