Quality Assurance Specialist

Duration:
Contract until Dec 2026 (Possible extension)

Description: The Senior Quality Specialist is part of the Quality Assurance Department at Ridgefield, NJ. This role is responsible through participation in the Supplier Management Team, track and manage Supplier Change Notice (Third Party Change Notification Process), maintaining the supplier corrective action program, and interaction with the individual supplier/vendor. The responsibilities include the following:

• Responsible for the site's Third-Party Change Notification process (TPCN), which includes logging, triaging, assigning, and determining the level of criticality.
• Responsible for tracking TPCN completion and preparing presentations for monthly meetings.
• Assist in reviewing and approving Third Party investigation reports related to Third Party Complaint and Supplier Corrective Action Report (SCAR).
• Additional tasks including updating Standard Operating Procedures (SOPs) and serving as a backup for various Quality Supplier department tasks.
• Assist in maintaining the Supplier Qualification Program for existing and new suppliers.
• Maintain professional relationships with suppliers/vendors to ensure adherence to quality standards and facilitate an environment of continual improvement.
• Implement projects, initiatives, and improvements as an individual contributor or as part of a team, ideally with project management experience.
• Perform trending and metric generation to ensure compliance and provide confidence that the relevant quality systems are operating in control.
• Collaborate with Manufacturing Operations, QA Management, Procurement, Suppliers, and Service Providers to provide advice and support in resolving compliance-related concerns and initiatives, proactively identifying areas of risk to compliance GMPs.
• Author, review, and approve GMP documentation and develop and deliver training related to supplier management topics.
• Assist in authoring, revising, and maintaining QTA’s between vendors and service providers, liaising with procurement and legal parties.

• Minimum two years of pharmaceutical industry experience.
• Strong understanding of FDA CFR Parts 11, 210, 211, and 820, ISO 13485, 9001 and/or other applicable regulations.
• Strong knowledge of quality and compliance in a regulated GxP/QMS environment.
• Handling ASL and QTAs, usage of Athena, QMS System.
• Very good communicator, writing, and organizational skills.
• Ability to multi-task.
• Adaptable to change.
• Ability to work in a team as well as independently.
• Ability to draw on past experiences to influence future outcomes.
• Ability to research information for problem resolution to projects.