B.S. or B.A. in Engineering, Sciences, or related discipline
Minimum two (2) years post-bachelor's 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.
Nice to Have Skills & Experience
Deviation Management
Data Analytics experience
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, 2 WFH.
Compensation:
$36-45/hr
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.