Job Description

One of our large pharmaceutical clients is actively seeking a Deviation Management Specialist to join the specialty products & services and incoming materials team located in West Point, PA. They will be responsible for ensuring that deviations are thoroughly investigated, risks are managed, and corrective actions are taken to maintain equipment quality & compliance in the pharmaceutical industry. This person needs to have experience authoring investigations & incidents for pharmaceutical raw materials. Their main responsibility is coordinating QNs (Quality Notifications), identify point of occurrence, investigate root cause, and evaluate product impact by using DM tools to close incidents and investigations by assigned due date.

 Authors incident and investigation reports for deviations

 Coordinates and completes Corrective Actions and Preventive Actions (CAPAs)

 Authors and reviews Incident Trend Reports

 Supports deviation reduction efforts

 Supports, executes, and/or leads continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process.

 Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.

 Authors, updates, and/or reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a Good Manufacturing Practice environment.

 Provides on-the-floor support for project implementation and studies, as required

 Leads or participates in Quality Risk Assessments.

 Supports team safety, environmental, and compliance objectives.

 Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.

 Collaborates effectively with Operations, Quality, Planning, project teams, and external vendors.

This role is a year long contract, potential extensions. 3 days onsite, 3 WFH.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

B.S. or B.A. in Engineering, Sciences, or related discipline

Minimum two (2) years post-bachelors degree experience in a regulated environment.

Experience in deviation management and/or change control and/or bio-pharm equipment

Technical Writing

Highly developed communication, leadership and teamwork skills. Deviation Management

Data Analytics experience null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.