Investigator II

Investigator II

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