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