Quality Specialist I Logistics

Parexel•Quakertown, PA

5d•$24 - $33•Onsite

About The Position

We are seeking a Quality Specialist I to join our team in an on-site capacity at our North America Distribution Center in Quakertown, PA. As a Quality Specialist I, you will support quality operations that help bring life-changing medicines to patients. This position plays a key role in quality assurance, regulatory compliance, and clinical supply chain integrity. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to quality operations from receipt through distribution. Responsibilities include executing quality checks on medicinal products, performing quality control tasks in depot and warehouse operations, and providing quality consultancy to operations personnel. You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through quality assurance, process improvement, and regulatory excellence. With diverse teams and continuous learning opportunities, the Quality Specialist I can explore career paths and expand skills across clinical research and supply chain operations.

Requirements

Bachelor's degree in technology, biological science, pharmacy, or other health-related discipline, or equivalent years of professional experience
Minimum 1 year of experience in a GMP (Good Manufacturing Practice) environment
Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
Experience with quality management systems and processes in a clinical or pharmaceutical setting
Strong communication, organization, and problem-solving skills

Nice To Haves

Experience in clinical research, pharmaceutical industry, or Clinical Research Organization (CRO) environments
Familiarity with Logistics Quality Management (LQM) support functions
Experience with quality management systems and documentation
Background in depot, warehouse, or supply chain quality operations

Responsibilities

Execute quality checks of medicinal products and clinical trial supplies during receipt, production, and distribution
Perform quality control tasks in depot and warehouse operations as assigned
Undertake local quality management tasks as described in Parexel controlled documents
Provide support for change control management related to premises, equipment, and processes
Support premise and equipment maintenance and cleaning activities
Perform reviews of Production Batch Records and support qualification and validation activities
Participate in Standard Operating Procedure (SOP) and process development initiatives
Serve as a quality consultant to operational groups, including process authoring, review, and expertise in GxP guidelines
Contribute to the development of training materials as a process subject matter expert
Support identification, management, and prevention of quality issues through audit and inspection support
Provide quality consultancy to operations personnel and verify compliance with GxP guidelines and regulations