Job Title:
Quality Specialist I

Introduction: 
At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life- changing medicines to patients. We are seeking a Quality Specialist I to join our team. As a Quality Specialist, you’ll be joining a fast-paced, driven environment that’s helping to make life-changing difference 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.  

Who we’re looking for:  

• 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. 

What you’ll do:  

• Execute quality checks of medicinal products and other quality critical clinical trial supplies during receipt, production, and distribution. 

• Provide support for change control management related to premises, equipment, and processes. 

• Support premise and equipment (P&E) maintenance and cleaning.

• Perform reviews of Production Batch Records.

• Identify process improvement opportunities and champion their implementation. 

• Participate in SOP and process development. 

• 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.  

Additional Details: 

• 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. 

• Must be educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or have equivalent years’ experience. 

• This is an in-person position at Parexel's North America Distribution Center located in Quakertown, PA.

Why join us:  

• Be part of groundbreaking projects that are pushing the boundaries of the industry.  

• Experience a collaborative and inclusive work environment that appreciates your expertise.

• Unlock your full potential with professional growth and development opportunities.  

Parexel US Benefits:  
Health, Vision & Dental Insurance  
Tuition Reimbursement  
Vacation/Holiday/Sick Time  
Flexible Spending & Health Savings Accounts  
Work/Life Balance  
401(k) with Company match  
Pet Insurance  
Full list of benefits available here: https://www.parexel.com/us-benefits  

If this job doesn’t sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, send them the link to apply!  

At Parexel we embrace flexibility and understand that in today’s fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you’re exposed to a world of experiences and open doors.