R&D Technician

Job title: Quality Specialist

Job duration: 12 months

Job location: Rahway, NJ

Job description:

This position reports to the Associate Director of Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via supporting disposition activities for clinical finished goods provided by our Company for worldwide clinical trials.

Specifically, this includes direct support for batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (GMP) regulations and relevant regulatory filing submissions.

Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types to support clinical protocols as well as Managed Access Programmes, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc.

Responsibilities may include, but are not limited to, the following:

Primary Responsibilities:

Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable. Policies/procedures of our Company and compliance with all governing regulations.

Coordinate and/or support the preparation of procedures, processes and quality improvements.

Assists in the coordination of significant quality events including fact-finding, investigation support, and coordination of clinical quarantine and recovery actions.

Collaboration across Integrated Process Team (IPT) functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.

Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.

Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times.

Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans, when possible.

Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (PS) tools, both in problem solving and day-to-day operational activities.

Qualifications:

Education Minimum Requirements:

Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred.