Regulatory Affairs Specialist - Intellectt INC

Murrysville, PA

Role: Regulatory Affairs Specialist
Location: Morrisville, PA
Type: Long Term Contract

Experience: 7+ years of experience in regulatory affairs with specific expertise in manufacturing line transfers.

Job Duties:

Support Manufacturing Line Transfer Activities: Ensure regulatory compliance during the line transfer process.
Quality Documentation: Assist in preparing and reviewing regulatory documents to ensure proper alignment with relevant regulatory standards.
Validation Activities: Participate in validation efforts such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) related to the line transfer process.
Trials and Statistical Techniques: Assist in the design and analysis of trials and validation using appropriate statistical methods.
Control Variables: Ensure that appropriate control variables are identified, measured, and managed during validation and line transfer processes.
Engineering Change Management: Support engineering change control processes, including the creation and management of engineering documents.
NCRs and CAPAs: Assist in identifying and addressing Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs) as required.

Required Qualifications:
Regulatory Affairs Specialist:

Bachelor's degree in a relevant field (Engineering, Regulatory Affairs, or similar).
7+ years of experience in regulatory affairs with a focus on manufacturing line transfers.
Strong understanding of validation activities including IQ, OQ, and PQ.
Experience with engineering change management and document control.

Source : Intellectt INC