Quality Assurance Specialist

Quality Assurance Lead Investigator - Sharonville, OHKelly Scientific is searching for Lead Investigators with Pharma Manufacturing Quality experience to work on non-critical deviations.***** Lead Investigator***** Sharonville, Ohio AreaLength of ***** 6-12 months***** $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 **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.**Bachelor's degree, preferably in Science, Engineering, or other related technical discipline.Experience in Quality Deviation ManagementExperience 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 investigationAbility 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

Created: 2025-02-19