The Investigator II is a hands-on role responsible for conducting investigations and providing guidance to other investigators related to deviations.
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
Support Manufacturing Investigation function during FDA, corporate GMPs and customers compliance audits
Participate in internal audits as applicable
Provide leadership in daily operations to other investigators
Four (4) years of relevant post-degree work experience in an Engineering, cGMP or quality position
Associates degree
Bachelor's or Master's degree in a technical field preferred
An equivalent combination of education and experience may be considered
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
Frequent standing and walking throughout the facility
Satisfactory audio-visual acuity
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