Job Description

One of our large pharmaceutical clients is actively seeking a Deviation Investigator to join the specialty products & services and incoming materials team located in Lansdale, 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. This role is a year long contract with potential for extensions and has a hybrid schedule of 3 days onsite & 2 days WFH. Other responsibilities include:

• Authors incident and investigation reports for deviations
• Coordinates and completes Corrective Actions and Preventive Actions (CAPAs)
• Authors and reviews Incident Trend Reports and support 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 and 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.

Qualifications:

• Bachelor's Degree in a related field of study
• Minimum of 2 years of deviation or change control management experience within a GMP environment
• Prior quality and deviation investigation experience
• Strong technical writing skills

Pay: $33.00-$37.00/hr (flexible based on experience)

Hours: Monday-Friday, 9:00am-5:00pm

Hybrid Schedule : 3 days onsite & 2 days WFH

Hiring Method : Multiyear contract – After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year

Benefits: Medical, Dental, Vision and 401K plans available

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.

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