Investigator II

Position Summary

The Investigator II is a hands-on role responsible for conducting investigations and providing guidance to other investigators related to deviations.

Duties and Responsibilities

Lead cross functional teams in the investigation of equipment and complex deviations Author deviation investigations and associated reports within required timeframes Manage the timely review and investigation of and respond to deviation queries from internal and external sources Collaborate with various departments to gather information, evaluate causal factors, and develop and implement effective corrective and preventive actions (CAPAs) Support and participate in client communications and responses related to deviations and investigations, working closely with program team leads, quality, and leadership Facilitate meetings with cross-functional stakeholders to drive alignment, clarify issues, and achieve desired outcomes for deviation investigations Prioritize and manage multiple investigations in a fast-paced environment while meeting quality and timeline expectations Evaluate data trends and perform trend analysis to make informed recommendations that improve quality processes and reduce recurrence of deviations Contribute to continuous improvement of quality assurance processes by sharing insights, lessons learned, and best practices from investigations.

Interface with Engineering, Quality, Materials, Manufacturing, and Project Management. Observe and investigate on the manufacturing floor and mechanical areas. Assist in compiling information for the Key Performance Indicators (KPI) on an as needed basis Attend and complete all mandatory training Demonstrate SSM values and behaviors at all times Other duties as assigned Regulatory Responsibilities Support Manufacturing Investigation function during FDA, corporate GMPs and customers compliance audits Participate in internal audits as applicable Supervisory Responsibilities Provide leadership in daily operations to other investigators Experience Four (4) years of relevant post - degree work experience in an Engineering, cGMP or quality position Education Associates degree Bachelor’s or Master’s degree in a technical field preferred An equivalent combination of education and experience may be considered Knowledge, Skills & Abilities Proficient in the use of MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area Familiarity of engineering concepts Time management Attention to detail while executing multiple tasks Well - organized Good oral and written communication skills, i.

e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills Physical Requirements Frequent standing and walking throughout the facility Satisfactory audio-visual acuity