Quality Specialist I Logistics

Parexel•Quakertown, PA

8d•Onsite

About The Position

Parexel is seeking a Quality Specialist I to join our onsite team within the Depot/Warehouse at our North America Distribution Center in Quakertown, PA, where you’ll play a key role in supporting quality operations that help bring life‑changing medicines to patients. As a Quality Specialist I, you’ll be joining a fast-paced, driven environment that’s helping to make life-changing differences to patients by identifying process improvement opportunities, contributing to the development of training materials, and providing audit and inspection support. Through collaboration and diversity of teams, the Quality Specialist I is provided with multiple opportunities to excel and discover where your skills can take you.

Requirements

Communicative individual with excellent interpersonal, verbal, and written communication.
Reliable contributor with the ability to take initiative and have a flexible approach to work assignments and new learning.
Critical thinker with a client focused mindset.
Multi-tasker that will manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills.
Able to work independently and also as part of a team.
Experience of working a minimum of one year in a GMP environment.
Must be educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or have equivalent years’ experience.

Nice To Haves

Relevant experience in the Clinical Research field (pharmaceutical industry or CRO), clinical or medical experience or other relevant experience in the areas Logistics Quality Management (LQM) support preferred.

Responsibilities

Execute quality checks of medicinal products and other quality critical 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, including depot and warehouse environments.
Support premise and equipment (P&E) maintenance and cleaning.
Undertake local P&E quality tasks as defined in Parexel procedures to cover local QA tasks.
Perform reviews of Production Batch Records.
Perform and support P&E qualification and validation activities.
Participate in SOP and development.
Serve as a quality consultant to designated operational group(s), including process authoring and review, process re-engineering support, provision of GxP and process expertise, contribution to the development of training materials as a process subject matter expert, support for identification, management, and prevention of quality issues, audit and inspection support, and assistance with the collection and reporting of quality metrics, as assigned.
Provide quality consultancy to operations personnel.
Verify compliance with GxP guidelines, local regulations, protocol, Parexel procedures and/or sponsor requirements.
Remain informed about developments in relevant regulations and guidelines.